LabMedica - Vol. 32 No.1 • 2-3
Transcription
LabMedica - Vol. 32 No.1 • 2-3
V I S I T W O R L D ’ S C L I N I C A L L A B O R AT O R Y N E W S L E A D E R ISSN 1068-1760 Vol. 32 No. 1 • 2-3 / 2015 DAILY CLINICAL LAB NEWS ® Molecular Test Identifies Acute Transplant Rejection T he development of noninvasive molecular assays to improve disease diagnosis and patient monitoring is a critical need in renal transplantation, as acute rejection (AR) increases the risk for chronic graft injury and failure. Acute rejection after kidney transplantation occurs in about 15% to 20% of patients despite Human Genome Mapping Gaps Revealed by Latest Technology T housands of never-before-seen genetic variants in the human genome have been uncovered using a new genome sequencing technology and these discoveries close many human genome-mapping gaps that have long resisted sequencing. The human genome is arguably the most complete mammalian refer- ence assembly, yet more than 160 euchromatic gaps remain and aspects of its structural variation remain poorly understood ten years after its completion. Euchromatin is chromosomal material that is genetically active and stains lightly with basic dyes. A team of scientists led by those at University of Washington ndometriosis is diagnosed and staged at surgery, resulting in an 11-year latency from symptom onset to diagnosis, underscoring the need for less invasive, less expensive approaches. Patterns of genetic activity have been identified that can be used to diagnose endometriosis and its severity, a finding that may offer Cont’d on page 9 Cont’d on page 6 Cont’d on page 5 D iagnosis of glaucoma may be simplified by the development of a gene sequencing technique that detects mutations in the mitochondrial DNA of glaucoma patients. Primary open-angle glaucoma occurs when optic nerve damage results in a progressive loss of the visual field. This is associated with increased first-of-its-kind platform enabling faster diagnosis of serious infections has been introduced. The new platform called IRIDICA and developed by Abbott can identify over 1,000 infection-causing pathogens in less than 6 hours – much quicker than current culture-based testing. Image: Courtesy of Abbott A Cont’d on page 8 INSIDE Clinical News . . . . . . . 4-24 IFCC News . . . . . . . . . . . .25 EFLM Corner . . . . . . . . . .28 EFLM Annual Review . . .32 Product News . . . . . 18-24 Industry News . . . . . . . . .33 International Calendar . 34 See article on page 4 I S I T LINKXPRESS COM R E A D E R S E R V I C E ® P O R T A L Renew /Start your Free Subscription Access Interactive Digital Magazine Instant Online Product Information: LinkXpress codes of 1 Identify interest as you read magazine ® on LinkXpress.com 2 Click to reach reader service portal code(s) of interest on 3 Mark LinkXpress inquiry matrix ® If your subscription is not renewed every 12 months your Free Subscription may be automatically discontinued E Mitochondrial Mutations In Glaucoma Identified Breakthrough Platform Improves Infectious Disease Diagnosis and Control V Noninvasive Test for Endometriosis Developed Device Rapidly Diagnoses Prostate Cancer new device facilitates the diagnosis of prostate cancer for doctors distinguishing between benign and malignant prostate tissue and through a visual analysis, the device can reliably determine if it is carcinoma within a minute-and-a-half. A PUBLISHED IN COOPERATION WITH Cont’d on page 4 Improved Assay Determines D-Xylose in Urine and Serum Antibody Test Predicts Cold-Related Asthma Attacks A A simple method for the evaluation of intestinal lactase activity in vivo has been developed and optimized in humans with potential advantages over current tests for the noninvasive diagnosis of lactase deficiency or hypolactasia. The phloroglucinol assay is the current method for d-xylose determination Cont’d on page 5 diagnostic marker can be used to identify the risk group for asthma attacks caused by rhinoviruses and this can be assessed with a simple antibody test. Rhinoviruses (RVs) are the most common cause of respiratory illnesses in children and adults of all ages and are responsible for more than half of Cont’d on page 8 International Federation of Clinical Chemistry and Laboratory Medicine GLOBETECH >>> M E D I A <<< Scan with Smartphone to Access Latest News LINKXPRESS COM LMI-03-15 102 LINKXPRESS COM LMI-03-15 103 LabMedica Breakthrough Platform Improves Infectious Disease Diagnosis and Control first-of-its-kind diagnostics technology platform to enable healthcare professionals to more quickly diagnose serious infections is now available in Europe and other CE-marking recognized countries worldwide. The new platform called IRIDICA was developed by Abbott (Abbott Park, IL, USA; www.abbott.com) and it can identify over 1,000 infectioncausing pathogens in less than 6 hours – much quicker than the current standard-of-care (culture-based testing), which can take days, in some cases weeks. Every minute can count with serious infections and this technology was developed to give doctors information needed to act more quickly and effectively in making life-saving decisions. IRIDICA, which currently offers 5 testing panels, has the potential to change how pathogens are detected and identified. “Doctors need better tools to diagnose people with serious infections,” said Prof. François Simon, MD, PhD, chief of Microbiology at Hôpital Saint-Louis (Paris, France). “For those with sepsis, the survival rate decreases each hour treatment is delayed.” IRIDICA employs Polymerase Chain Reaction/Electrospray Ionization Mass Spectrometry (PCR/ESI-MS) to rapidly identify infection-causing pathogens directly from a patient’s sample, without culture. According to Abbott’s “RApid Diagnosis of Infections in the CriticAlly IlL” (RADICAL) study results, the technology was able to detect pathogens when the current standard-ofcare did not. In the study, after retrospectively comparing the results of Abbott’s technology versus culture, an independent panel of physicians concluded it would have prescribed a different course of treatment in nearly 60% of cases evaluated. Additional analysis suggested it could help lower associated health care costs by 30% and reduce hospital stays for people with serious A Presently to make a definitive diagnosis doctors take a biopsy of prostate tissue from the patient. In doing so, they insert a small needle into the prostate, using ultrasound images to assist with navigation. From the sample taken in this way, laboratory staff laboriously makes histological slides. The tissue sections are forwarded to a pathologist, who examines them under the microscope and even for experienced physicians, it is often difficult to distinguish between benign and malignant tissue. Scientists at the Fraunhofer Institute for Ceramic Technologies and Systems (IKTS; Dresden, Germany; www.izfp-d.fraunhofer.de) developed an optical diagnostic device to distinguish benign prostate tissue from neoplasms. According to the inventors, the physician places the removed tissue sample on a base plate, slides it into the machine, presses a button and within oneand-a-half minutes, receives a reliable indication of whether the tissue in the sample is benign or malignant. Since the sample does not require a long preparation time and can be pushed directly into the device and analyzed after it has been taken, the patient does not have to wait for days after the biopsy in order to EDITORIAL BOARD Claus Christiansen Denmark Hernán Fares Taie Argentina Bernard Gouget France Jocelyn M. Hicks United States Anders Kallner Sweden Tahir S. Pillay South Africa Christopher Price United Kingdom Andreas Rothstein Colombia Dmitry B. Saprygin Russia Rosa I. Sierra-Amor Mexico Gérard Siest France Peter Wilding United States Andrew Wootton United Kingdom A GLOBETECH PUBLICATION Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). HospiMedica International • HospiMedica en Español • HospiMedica China LabMedica International • LabMedica en Español • LabMedica China Medical Imaging International • Bio Research International • Medimaging.net HospiMedica.com • LabMedica.com • BiotechDaily.com • TradeMed.com infections by up to 8 days (for a hospital that sees approximately 500 patients with blood-related infections each year. Costs were derived from intensive care and non-intensive care lengths of stay). “Currently, when a person enters a hospital with a suspected infection, it may take several days before the source can be accurately identified,” said David J. Ecker, PhD, divisional vice president, R&D, Ibis Biosciences, Abbott, “IRIDICA can offer a better and faster way.” IRIDICA also represents a step forward in combating overuse of antibiotics. “Slower diagnostic methods, like cultures, have led to the overuse of broad-spectrum antibiotics and antimicrobials and an emergence of new resistant superbugs,” said Jean-Louis Vincent, MD, PhD, professor of Intensive Care, Université Libre de Bruxelles (Belgium). “By identifying pathogens faster with IRIDICA, a doctor can quickly prescribe the most effective therapy, potentially limiting the indiscriminate use of broad-spectrum antibiotics.” Image: The IRIDICA platform can identify more than 1,000 infection–causing pathogens in less than six hours, versus the current standard of care (culture-based testing), which can take days (Photo courtesy of Abbott). Device Rapidly Diagnoses Prostate Cancer cont’d from cover labmedica.com know the outcome. The doctor receives the results immediately and can talk with the patient much sooner about the next steps to take. The analyses are based on the autofluorescence that human tissue emits. There are fluorophores in every human body. These molecules are illuminated for a very short time when certain light falls on them. If the doctor sets the removed tissue in the device, starts the measurement, emits a dosage of laser pulse and excites the fluorophores, then the laser pulse stimulates the fluorescent molecules in the tissue to release light. The way in which this fluorescence radiation decreases differs between benign and malignant tissue. The scientists have been able to determine a clear threshold for this different behavior: If the value of the tissue sample exceeds the threshold value, carcinoma is present. The optical diagnostic device has already completed its first two clinical studies, and the third study is currently underway. A prototype is currently available. The scientists presented the 53 × 60 × 43 centimeter prototype at the COMPAMED trade fair held November 12–14, 2014, in Düsseldorf (Germany; www.compamed-tradefair.com). Dan Gueron Jacqueline Miller, PhD Raymond L Jacobson, PhD Gerald Slutzky, PhD Andreas Rothstein Marcela Jensen Joseph Ciprut Brenda Silva Paul Mills Doris Mendieta Dr. Jutta Ciolek Christina Chang Carolyn Moody Arda Turac Elif Erkan Publisher News Director News Editor News Editor News Editor Assistant Editor Assistant Editor New Products Editor Regional Director Regional Director Regional Director Regional Director Business Development Director Production Director Reader Service Manager HOW TO CONTACT US Subscriptions: Send Press Releases to: Advertising & Ad Material: Other Contacts: www.LinkXpress.com [email protected] [email protected] [email protected] ADVERTISING SALES OFFICES USA P.O.Box 800806, Miami, FL 33280, USA [email protected] Tel: (1) 954-893-0003 GERMANY, SWITZ., AUSTRIA Bad Neustadt, Germany [email protected] Tel: (49) 9771-3528 UK, FRANCE, NORDIC REG. [email protected] Gerrards Cross, UK Tel: (44) 1753-892-791 ITALY [email protected] Genoa, Italy Tel: (39) 10-570-4948 JAPAN [email protected] Tokyo, Japan Tel: (81) 3-5691-3335 CHINA Shenzen, Guangdong, China [email protected] Tel: (86) 755-8375-3877 ALL OTHER COUNTRIES [email protected] Contact USA Office Tel: (1) 954-893-0003 SUBSCRIPTION INFORMATION LabMedica lnternational is published eight times a year and is circuIated worldwide (outside the USA and Canada) without charge and by written request, to clinical laboratory specialists and administrators, and other qualified professionals allied to the field. To all others: Paid Subscription is available for a twoyear subscription charge of US$240. Single copy price is US$20. Mail your paid subscription order accompanied with payment to Globetech Media, P.O.B. 802214, Miami, FL 33280-2214. For change of address or questions on your subscription, write to: LabMedica lnternational, Circulation Services at above address; or visit: www.LinkXpress.com ISSN 1068-1760 Vol.32 No.1. Published, under license, by Globetech Media LLC; Copyright © 2015. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul, Türkiye Faks: (212) 216-6997 • P. K. 1, AVPIM, 34001 İstanbul Baskı: Promat Web Ofset Tesisi • Orhangazi Mahallesi 1673. Sokak No: 34 • 34510 Esenyurt, B. Çekmece • İstanbul, Türkiye Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır. LabMedica International February-March/2015 4 LabMedica for daily laboratory medicine news click to www.labmedica.com Molecular Test Identifies Acute Transplant Rejection cont’d from cover immunosuppressive therapy and rejection is usually heralded by an increase in the patient’s serum creatinine, which is a marker of kidney function, and a kidney biopsy is then performed to confirm whether rejection is taking place. Scientists at the University of California (San Francisco, CA, USA; www.ucsf.edu) working with an international team used 558 peripheral blood (PB) samples from 438 adult and pediatric renal transplant patients from eight renal transplant centers in the United States, Mexico, and Spain and enrolled between 2005 and 2012 to develop a quantitative real-time polymerase chain reaction (qPCR) test. They developed the test in 143 samples from adults with and without acute rejection as determined by kidney biopsy, and then finalized and validated the test in three cohorts of patients. Total ribonucleic acid (RNA) was extracted using the column-based method kits and was measured for RNA integrity using the RNA 6000 Nano LabChip Kit on a 2100 Bioanalyzer (Agilent Technologies; Santa Clara, CA, USA; www.agilent. com). Microfluidic qPCR was performed on the 96.96 dynamic array and the chip loaded via the HX IFC Controller and performing the qPCR in the BioMark qPCR platform (Fluidigm; South San Francisco, CA, USA; www.fluidigm.com). The team evaluated the differential expression of 10 out of 43 genes, selecting the same ten genes that have been validated as diagnostic for AR in PB using standardized clinical trial sample collection and processing protocols. To improve the diagnostic accuracy for AR in the 143 adult samples, various statistical modeling methods were used to include an additional seven genes which improved the accuracy of the gene panel for discriminating AR from No-AR samples, for a final selection of 17 genes. The assay was called kSORT and was able to classify patients as high risk versus low risk for AR. The kSORT assay was able to detect AR in blood independent of age, time post-transplantation, and sample source without additional data normalization. The authors concluded that the kSORT assay is a simple, robust, and clinically applicable blood test. They are using kSORT in a prospective observational trial as well as a second prospective, randomized, double-blinded clinical interventional trial, which will establish how kSORT can be used serially post-transplant to complement current clinical practice guidelines for stratifying patient immune risk, medication load, and requirement for biopsy. The study was published on November 11, 2014, in the journal Public Library of Science Medicine. Improved Assay Determines D-Xylose in Urine and Serum cont’d from cover in urine, plasma, or serum; however, its sensitivity is limited when low amounts of D-xylose are to be measured, such as in the noninvasive evaluation of intestinal lactase with 4-galactosylxylose (gaxilose). Clinical chemists at the Universidad Autónoma de Madrid (Spain; www.uam.es) obtained 25 human urine and venous blood samples from healthy subjects who attended a local hospital. D-xylose and gaxilose determination in urine and serum after oral gavage of gaxilose was performed in six hypolactasic subjects with lactase activity in small intestine biopsy of less than 10 U/g protein enrolled in a multicenter, open label, nonrandomized trial, designed to address the diagnostic performance of the gaxilose test. D-xylose determination was carried out using a modification of the phloroglucinol method and the absorbance in the colorimetric assay of D-xylose was read using a double beam spectrophotometer (Hitachi, Tokyo, Japan; www.hitachi.com) set at 554 nm. A method for gaxilose determination by gas chromatography (GC) was also optimized. The linearity of the improved D-xylose assay ranged from 0.125 to 5.0 mg/L as compared to 5 to 200 mg/L by the original method. Accuracy at the lower limit of quantification (LOQ), 0.125 mg/L, was 0.97%/2.49% in spiked urine or serum. For other quality controls (QC), it was less than 1.27%. Intra- and inter-assay precision at LOQ were 6.02% and 6.45% for urine, and 8.86% and 10.00%, respectively, for serum and for other QC; precision was less than 2.15%. Linearity of gaxilose determination by GC was 3.90 to 195.17 mg/L for urine and 9.75 to 95.17 mg/L for serum with acceptable sensitivity and reproducibility. The method proved adequate for the D-xylose determination in healthy and hypolactasic subjects after oral administration of gaxilose. The authors concluded that the modified method provides high sensitivity and robustness for D-xylose quantification in urine and serum samples for routine clinical use especially in the noninvasive diagnosis of intestinal lactase deficiency with the gaxilose test. The study was published in the November 2014 issue of the Journal of Clinical Laboratory Analysis. 5 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 105 LabMedica to read this issue in interactive digital magazine format click to www.LinkXpress.com Noninvasive Test for Endometriosis Developed cont’d from cover millions of women an alternative to surgery through a simple noninvasive procedure. Scientists at the University of California San Francisco (CA, USA; www.ucsf.edu) identified 148 archived endometrial samples from different menstrual cycle phases from 77 women with endometriosis and pelvic pain and/or infertility; 37 with no endometriosis but with uterine/ pelvic pathology (NE.UPP) including symptomatic uterine fibroids, pelvic PREMIER MULTIMEDIA PLATFORM SERVING THE WORLD’S CLINICAL LABORATORY COMMUNITY Anytime, Anywhere, On the Go... PRINT MAGAZINE INTERACTIVE DIGITAL EDITION WEB PORTAL NEW: RUSSIAN EDITION Website Editions: English Spanish Chinese Russian labmedica.com organ prolapse, and adenomyosis; and 34 with no endometriosis and no uterine/pelvic pathology (NE.NUPP), classified as normal controls. Whole-tissue samples were processed using rigorous protocols and hybridized to whole-genome microarrays. Total ribonucleic acid (RNA) was purified from specimens, and only high-quality RNA samples were processed for hybridization to Human Genome 133 Plus 2.0 high-density oligonucleotide arrays (Affymetrix; Santa Clara, CA, USA; www. affymetrix.com). Menstrual cycle phase was assigned by endometrial histology reviewed by two pathologists, and confirmed by serum estradiol and P4 levels. The team used machine learning, a computer-based technology, to analyze the gene activity of the endometrium tissue samples. With an accuracy of 90% to 100 %, a grouping system from the samples was developed. Not only could the investigators distinguish between samples from endometriosis patients and the control group but also between the endometriosis patients and those patients with other uterine disorders. They even could denote the difference between endometriosis stages. This technique also could distinguish endometriosis at different points in the menstrual cycle. As hormone levels changed throughout the cycle, the gene expression patterns in the uterine lining of women with endometriosis were distinct from those who did not have the condition. Based on this gene expression, a simple test eventually could be performed in the doctor’s office to determine endometriosis and stage. In just minutes, a tiny, thin plastic catheter could be inserted through the cervix into the uterus to remove a sample of cells for analysis. Louis V. DePaolo, PhD, a contributing author of the study said, “Laparoscopy involves general anesthesia and making an incision in the abdomen. These findings indicate that it may be possible to avoid the surgical procedure and diagnose endometriosis from a tissue sample obtained in the office setting without anesthesia.” The study was published on September 22, 2014, in the journal Endocrinology. Image: A photomicrograph showing endometriosis of the ovary (Photo courtesy of Nephron). LabMedica International February-March/2015 6 LINKXPRESS .COM LINKXPRESS .COM LMI-03-15 254 LINKXPRESS .COM LMI-03-15 260 LINKXPRESS .COM LMI-03-15 261 LINKXPRESS .COM LMI-03-15 262 LMI-03-15 253 LINKXPRESS .COM LMI-03-15 255 LMI-03-15 251 LINKXPRESS .COM LINKXPRESS .COM LMI-03-15 259 LMI-03-15 250 LINKXPRESS .COM LINKXPRESS .COM LINKXPRESS .COM LMI-03-15 256 LMI-03-15 252 LINKXPRESS .COM LMI-03-15 257 LINKXPRESS COM LINKXPRESS .COM LMI-03-15 107 LMI-03-15 258 LabMedica to read this issue in interactive digital magazine format click to www.LinkXpress.com Antibody Test Predicts Cold-Related Asthma Attacks cont’d from cover all acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD). Immunologists at the Medical University of Vienna (Austria; www.meduniwien.ac.at) working with their colleagues in the UK studied the response to infections with RV16 that were induced in 28 asthmatic patients (11 with mild asthma and 17 with moderate asthma and 11 healthy adult individuals. The healthy adult subjects were non-smoking, non-atopic and non-asthmatic volunteers aged 21 to 55 years. Patients with mild asthma were aged 19 to 53 years taking only short-acting 2 agonists (SABA). The patients with moderate asthma, aged 20–54 years were on SABA) plus inhaled corticosteroid therapy. Total immunoglobulin E (IgE) levels were measured using ImmunoCAP technology (Phadia; Uppsala, Sweden; www.phadia.com); healthy median: was 16 IU/mL; mild asthmatics median: was 207 IU/mL; and moderate asthmatics median was 132 IU/mL. Enzyme-linked immunosorbent assays (ELISA) were performed with expressed and purified recombinant RV coat proteins VP1-4, nonstructural proteins as well as Nterminal fragments of VP1 from four RV strains (RV14, 16, 89, C) covering the three known RV groups (RV-A, RV-B and RV-C) and measured specific IgG-subclass-, IgA- and IgM-responses in subjects with different severities of asthma or without asthma before and after experimental infection with RV16. The optical density (OD) values corresponding to the levels of antigen-specific antibodies were measured at 405 and 490 nm in an ELISA reader (Dynatech; Denkendorf, Germany; www.dynextechnologies.com). The results of the subsequent antibody tests using recombinant virus antigens that were developed showed that the asthmatics who experienced attacks expressed significantly higher antibodies to the structure protein VP1, which is found in all of the known 150 or so rhinovirus strains, than any of the other subjects. The raised antibody response to VP1 now allows all individuals who need particular protection against colds to be identified. The authors concluded that ultimately serological tests may be helpful for identifying the most common and clinically relevant rhinovirus strains involved in asthma exacerbations and to investigate in cross-sectional studies the possible role of rhinovirus infections in other respiratory diseases, in different geographic populations and age groups including not only children but also adults and elderly persons. The study was published on November 18, 2014, in the journal EbioMedicine. Image: A depiction of Rhinovirus 16 (RV16), a common cause of respiratory illnesses (Photo courtesy of Jean-Yves Sgro). DNA Sequencing Identifies Mitochondrial Mutations in Glaucoma Patients cont’d from cover pressure in the eye, which is caused by trabecular blockage. Since the microscopic passageways are blocked, the pressure builds up in the eye and causes imperceptible very gradual vision loss. Peripheral vision is affected first, but, if not treated, vision will eventually be lost entirely. Previous studies have produced evidence suggesting that glaucoma is linked to mitochondrial dysfunction. Investigators at the University of Liverpool (United Kingdom; www.liv.ac.uk) sought to confirm that mutations in mitochondrial DNA played a role in high-pressure primary open-angle glaucoma by analyzing new data from massively parallel sequencing of mitochondrial DNA. To this end they recruited glaucoma patients with high-tension primary open-angle glaucoma together with ethnically matched and age-matched control subjects. The entire human mitochondrial genome was amplified in two overlapping fragments by long-range polymerase chain reaction (PCR) and used as a template for massively parallel sequencing on an Ion Torrent Personal Genome Machine (Life Technologies; Carlsbad, CA, USA; www.lifetechnologies.com). Life Technologies is a subsidiary of Thermo Fisher Scientific (Waltham, Massachusetts, USA; www.thermofisher.com). Results revealed that in 16 of 32 patients with primary open-angle glaucoma, there were 22 mitochondrial DNA mutations consisting of seven novel mutations and eight previously reported disease-associated sequence variants. Eight of 22 (36.4%) of the mitochondrial DNA mutations were in complex I mitochondrial genes. Senior author Dr. Colin Willoughby, professor of aging and chronic disease at the University of Liverpool, said, “Understanding the genetic basis of glaucoma can direct care by helping to determine the patient’s clinical risk of disease progression and visual loss. Increasing evidence suggests that mitochondrial dysfunction results in glaucoma and drugs that target mitochondria may emerge as future therapeutic interventions. Further studies on larger glaucoma numbers of patients are required to firmly establish the link between genetic defects in the mitochondrial genome and glaucoma development. Our research, however, has demonstrated that massively parallel sequencing is a cost-effective approach to detect a wide spectrum of mitochondrial mutations and will improve our ability to understand glaucoma, identify patients at risk of the disease or visual loss and support the development of new treatments.” The study was published in the September 18, 2014, online edition of the journal Genetics Medicine. Image: The Ion Torrent Personal Genome machine (Photo courtesy of Life Technologies). LINKXPRESS COM LMI-03-15 108 LabMedica International February-March/2015 8 LabMedica for daily laboratory medicine news click to www.labmedica.com Human Genome Mapping Gaps Revealed by Latest Technology cont’d from cover School of Medicine (Seattle, WA, USA; www.uwmedicine.org) identified missing sequence and genetic variation, by sequencing and analyzing a haploid human genome Leukocyte Cell Derived Chemotaxin 1 (CHM1) using single-molecule, real-time DNA sequencing. The technique used is called single-molecule, real-time DNA sequencing (SMRT), which may now make it possible for investigators to identify potential genetic mutations behind many conditions whose genetic causes have long eluded scientists. SMRT whole genome sequencing (WGS) data with 41-fold sequence coverage was generated using a PacBio RSII instrument (Pacific Biosciences Menlo Park, CA, USA; www.pacificbiosciences.com) from genomic libraries generated from a complete hydatidiform mole DNA (CHM1tert). This approach successfully pinpointed millions of small variations in the human genome. These variations arise from substitution of a single nucleotide base, called a single-nucleotide polymorphisms or SNP. The standard approach also made it possible to identify very large variations, typically involving segments of DNA that are 5,000 bases long or longer. But for technical reasons, scientists had previously not been able to reliably detect variations whose lengths are in between, those ranging from about 50 to 5,000 bases in length. The SMRT technology used in the study made it possible to sequence and read DNA segments longer than 5,000 bases, far longer than standard gene sequencing technology. The team was able to identify and sequence 26,079 segments that were different from a standard human reference genome used in genome studies and most of these variants, about 22,000, have never been reported before. Evan E. Eichler, professor of genome sciences and senior author of the study said, “In five years there might be a longread sequence technology that will allow clinical laboratories to sequence a patient’s chromosomes from tip to tip and say, ‘Yes, you have about three to four million SNPs and insertions deletions but you also have approximately 30,000–40,000 structural variants. Of these, a few structural variants and a few SNPs are the reason why you’re susceptible to this disease.’ Knowing all the variation is going to be a game changer.” The study was published on November 10, 2014, in the journal Nature. Image: The PacBio RSII system, designed for monitoring and analyzing SMRT sequencing reactions (Photo courtesy of Pacific Biosciences). V I S I T LINKXPRESS COM R E A D E R S E R V I C E ® P O R T A L Renew / Start your Free Subscription Access Interactive Digital Magazine Instant Online Product Information 9 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 109 LabMedica to read this issue in interactive digital magazine format click to www.LinkXpress.com Whole Cell Glycated Hemoglobin Control Calibrated for Most Popular Instruments aboratories that measure glycated hemoglobin (HbA1c) now have available a whole blood cell control material that has been calibrated for several major autoanalyzers. HbA1c is a derivative of hemoglobin that is formed nonenzymically by reaction at the N terminus of the protein molecule with glucose. In the normal adult human such derivatives constitute a few percent of the total erythrocyte hemoglobin, the most abundant being hemoglobin A1c, which increases several fold in concentration in diabetes mellitus, and is assayed to monitor control of diabetes. Once a hemoglobin molecule is glycated, it remains that way. A buildup of glycated hemoglobin within the red cell, therefore, reflects the average level of glucose to which the cell has been exposed during its lifecycle. Measuring glycated hemoglo- L bin assesses the effectiveness of therapy by monitoring long-term serum glucose regulation. The HbA1c level is proportional to average blood glucose concentration over the previous four weeks to three months. The American Diabetes Association and the World Health Organization have suggested that an HbA1c level of 6.5% or more is an indicator of type II diabetes and an HbA1c level of between 5.7 and 6.4% is an indicator of pre-diabetes. Streck, Inc. (Omaha, NE, USA; www.streck.com), an industry leader in the development and manufacturing of products for clinical and research laboratories, has released its A1c-Cellular control product, the only HbA1c control on the market with intact red blood cells. The A1c-Cellular control is convenient to use, as it does not require reconstitution. It controls the entire HbA1c assay procedure, including the lysing of the red blood cells – a step omitted with other controls. This important feature ensures the entire system – instrument and reagents – is working properly and providing accurate patient results. The A1c-Cellular control has been calibrated and certified for use on many of the major clinical autoanalyzers including: the Abbott (North Chicago, IL, USA; www.abbott.com) ARCHITECT c Systems; the Beckman Coulter (Indianapolis, IN, USA; www.beckmancoulter.com) UniCel DxC 600/800; the Bio-Rad (Hercules, CA, USA; www.bio-rad.com) D-10/Variant II and Variant II Turbo; the Roche (Pleasanton, CA, USA; http://molecular.roche.com) cobas INTEGRA/6000/c311; the Siemens (Malvern, PA, USA; www.siemens. com) Dimension Series; and the Tosoh (Grove City, OH, USA; www. tosohusa.com) A1c analyzer, HLC723G7. A1c-Cellular control is available in two clinically significant levels: 4%–7% HbA1c (Level 1) and 9%– 13% HbA1c (Level 2). Image: The A1c-Cellular chemistry control, available in two levels (Photo courtesy of Streck). Automated Assay for Influenza and RSV Cleared he US Food & Drug Administration (FDA) has cleared an on-demand automated molecular test for rapid, reliable determination of Flu A, Flu B, and differentiation of respiratory syncytial virus (RSV) infection. Redundant targets extend coverage for detection of seasonal and emerging new influenza strains. The FDA-cleared Xpert Flu/RSV XC cartridge test from Cepheid (Sunnyvale, CA, USA; www.cepheid.com) runs on GeneXpert System, Cepheid’s leading molecular diagnostic platform, with more than 7,500 systems installed worldwide. Upper respiratory infections are one of the most common reasons for doctor and hospital visits and T in the US are the most common illnesses leading to school or work absences. RSV is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age. With Xpert Flu/RSV XC, hospitals and clinicians can be prepared to reliably diagnose and differentiate influenza strains and RSV in real-time. Doctors Donna M. Wolk and Raquel M. Martinez, investigators at Geisinger Health System, were involved in investigational testing of Xpert Flu/RSV XC during Cepheid’s product development phase. Their microbiology team is planning a pilot testing program called FluWorks, which aims to allow test results to LINKXPRESS COM LMI-03-15 110 be immediately delivered to physicians and patients or designated family members via electronic health records, web portal, or text-messaging. “We are anxious to understand the role that the Xpert Flu/RSV XC test can play in Geisinger’s FluWorks program, designed to improve patient care, clinical operations, and laboratory stewardship. Rigorous investigational testing documented the assay’s high accuracy and speed,” said Dr. Wolk, “This winter, we plan to leverage the test’s unique design to quickly test patients presenting with influenza-like illness at emergency departments, outpatient clinics, and in selected urgent-care clinics.” LabMedica International February-March/2015 10 LINKXPRESS COM LMI-03-15 111 LabMedica to read this issue in interactive digital magazine format click to www.LinkXpress.com Fecal Testing Effective For Familial Colorectal Cancer Screening ecal immunochemical tests may be as effective as colonoscopies when it comes to detecting colorectal cancer among first-degree relatives of patients with colorectal cancer (CRC). First-degree relatives of patients with nonsyndromic colorectal cancer (CRC) are at higher risk of developing CRC than the general population and personal risk in these individuals has mostly been related to the age of the index case at diagnosis, degree of kinship, and number of relatives affected. Gastroenterologists at the Universidad de La Laguna (Tenerife, Spain; www.ull.es) conducted a prospective study of 1,918 first-degree relatives of patients with CRC who were randomly assigned to receive a single colonoscopy examination or three F fecal immunochemical tests (FITs). One test was done per year for three years; with a cutoff equal to or greater than 10 μg hemoglobin/g feces which corresponds to 50 ng hemoglobin/mL buffer. Individuals assigned to the FIT group were provided with a single OC-Sensor Fecal Immunochemical Test kit (Eiken Chemical; Tokyo, Japan; www.eiken. co.jp). The samples were analyzed on Eiken’s automated machine for detecting hemoglobin in stool samples. Participants were asked to keep fecal samples at 4 °C and return them within five days after sampling. Colonoscopies were performed by four experienced endoscopists who were blinded to group assignment. The repeated FIT screening detected all colorectal cancers and 61% of advanced adenomas, thus proving equivalent to one-time colonoscopy screening in terms of diagnostic yield and tumor staging. However, colonoscopy was superior to the FIT strategy for the detection of non-advanced adenomas. The usefulness of FIT screening as an alternative to colonoscopy in the familial risk population will ultimately depend on the capacity of FIT to improve screening uptake. The authors concluded that the results of their randomized trial demonstrated in asymptomatic first-degree relatives of patients with CRC that screening with FIT is equivalent to one-time colonoscopy for the detection of advanced neoplasia. In addition, it also provides evidence for the benefit of repeated FIT screening in terms of colonoscopy resources. Enrique Quintero, MD, PhD, the lead author of the study said, “In our study, repeat FIT screening detected all colorectal cancers in asymptomatic first-degree relatives of patients with colorectal cancer. These findings suggest that FIT screening should potentially be considered for familial screening, especially in populations where colonoscopy capacity is limited and/or compliance with colonoscopy is a concern.” The study was published in the November 2014 issue of the journal Gastroenterology. Image: The OC-Sensor, a fully automatic system for immunochemical FOBT, designed for the early detection of colon cancer (Photo courtesy of Eiken Chemical). Effectiveness of Chemotherapy Gauged by Optical Monitoring of Tumor Organoids aser-modulated optical metabolic imaging of organoids derived from primary breast tumors can gauge the therapeutic response of the cancer to antitumor drugs. Investigators at Vanderbilt University (Nashville, TN, USA; www.vanderbilt.edu) generated organoids from primary breast tumors by growing biopsy specimens from the tumors in a nutrientrich collagen gel that enabled the tumor to retain its three-dimensional structure and included supporting cells from the primary tumor’s microenvironment. Fluorescence imaging was used to monitor the metabolic state of the organoids. This technique utilized a laser that caused two key metabolic enzymes, FAD (flavin adenine dinucleotide) and NADH (nicotinamide-adenine dinucleotide) in the cells to fluoresce, with the strength of the fluorescence dependent on the health of the organoid. The method was tested extensively in mice and with six samples of human breast tumors using four anticancer drugs commonly used to treat breast cancer and two experimental drugs. Results re- L LINKXPRESS COM LMI-03-15 112 vealed that as early as 24 hours after treatment with the anticancer drug, the optical metabolic imaging index of responsive organoids decreased and was further reduced when effective therapies were combined, with no change in drug-resistant organoids. Drug response in mouse xenograft-derived organoids was validated with tumor growth measurements in vivo and staining for proliferation and apoptosis. Senior author Dr. Melissa C. Skala, assistant professor of biomedical engineering at Vanderbilt University, said: “We hit the tumor with a punch and see how it responds. It is cheap and fast and adaptable to high-throughput screening so it can be used to test dozens of drugs or drug combinations at the same time. We hope that our test will significantly improve the odds of survival of breast cancer patients by allowing doctors to identify the most effective but least toxic form of chemotherapy for each individual patient before the treatment begins.” The study was published in the September 15, 2014, issue of the journal Cancer Research. LabMedica International February-March/2015 12 LabMedica for daily laboratory medicine news click to www.labmedica.com HIV Combo Test Receives CLIA Waiver rapid point-of-care test that detects both human immunodeficiency virus (HIV-1/2) antibodies and free HIV-1 p24 antigen has been granted a Clinical Laboratory Improvement Amendments (CLIA) Waiver. The test has been available for sale in the USA to health facilities and laboratories licensed to conduct tests of moderate complexity and now with this approval, the test will now be available for use in physician offices, clinics and other public health settings as well. The US Food and Drug Administration (FDA; Silver Springs, MD, USA; www.fda.gov) have granted a CLIA Waiver for the fourth generation Alere Determine HIV-1/2 Ag/Ab Combo test (Alere; San Diego, CA, USA; www.alere.com). The capability of the test to detect p24 antigen, which can appear in only days after infection and before the HIV antibody is detectable, may detect HIV infection earlier A in the course of the disease. Earlier detection allows healthcare providers to improve clinical outcomes through earlier diagnosis and treatment of patients who test positive for HIV. Eugene Martin, PhD, professor of pathology and laboratory medicine at Rutgers University (Piscataway Township, NJ, USA; www.rutgers.edu) said, “I’m excited to learn that Alere Determine HIV-1/2 Ag/Ab Combo has been granted CLIA waiver and will be available for broader use in HIV screening. The promise of a fourth-generation, rapid HIV test is one that we all look forward to since it will allow screening locations to potentially identify early HIV infections, and to steer those who are most at risk of infecting others into treatment sooner.” Avi Pelossof, global president of infectious disease at Alere, said, “The CLIA Waiver of the Alere Determine HIV-1/2 Ag/Ab Combo will help facilitate accurate and early detection of HIV, which is critical to stemming the spread of HIV/AIDS in the United States, and will have a positive economic impact by bringing a critical healthcare service nearer to patients. Broadening the test’s availability to laboratories, physician offices, clinics and other public health settings, advances Alere’s commitment to delivering reliable and actionable information through rapid diagnostics.” Image: The Determine HIV-1/2 Ag/Ab combo test (Photo courtesy of Alere). Test Confirms Presence of Human T-Cell Lymphotropic Virus-I/II Antibodies supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II) has been licensed and is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on other HTLV-I/II blood donor screening tests. The Human T-cell Lymphotropic viruses (HTLV) are a group of human retroviruses known to cause diseases such as adult T-cell leukemia/lymphoma, which is a rare form of blood cancer and inflammation of the nerves in the spinal cord, known as myelopathy, as well as other conditions such as uveitis, and infectious dermatitis. HTLV can be transmitted from person to person through breastfeeding, unprotected sexual contact, or transfusion of blood from an infected donor. The US Food and Drug Administration (FDA; Silver Springs, MD, USA; www.fda.gov), which has approved the test require that donated blood be tested for HTLV-I/II antibodies. Currently there are two FDA-licensed screening tests for HTLV-I/II. If the test is positive, the donation is discarded and the donor is notified of his or her deferral. The MP Diagnostics HTLV Blot 2.4 (MP Biomedicals Asia Pacific Pte Ltd.; Singapore; www.mpbio. com), is a qualitative enzyme immunoassay test, that provides blood establishments with additional information to convey to the donor; specifically, the test can confirm HTLV infection and determine which virus type is causing the infection, HTLV-I or HTLVII. Many people who are infected with HTLV are unaware of the infection because the virus may not cause any symptoms or signs of infection. Additionally, many people infected with HTLV-I or HTLV-II may never develop any disease caused by the viruses. However, these asymptomatic carriers can still transmit the viruses to others. Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, said, “The approval of MP Diagnostics HTLV Blot 2.4 will help blood establishments better counsel donors who have had positive results on an FDA-licensed HTLVI/II screening test.” A 13 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 113 LabMedica to read this issue in interactive digital magazine format click to www.LinkXpress.com Low-Cost Sophisticated Device Diagnoses HIV he diagnosis of human immunodeficiency virus (HIV) and other infectious diseases present unique challenges in remote locations that lack electric power, refrigeration, and appropriately trained health care staff. A low-cost, electricity-free device has been developed that uses a small-scale chemical reaction, rather than electric power, to provide the heat needed to amplify and detect the DNA or RNA of pathogens present in blood samples obtained from potentially infected individuals. Scientists at an international nonprofit global health organization (PATH; Seattle, WA, USA; www.path.org) developed and continued to improve a system known as NINA, for non-instrumental nucleic acid amplification. The goal was to expand access to accurate diagnostics wherever they are needed, especially those areas that lack reliable electricity. The amplification process involves extracting nucleic acids from an individual’s blood sample, mixing it with a nucleic acid segment from the pathogen of interest, and using constant temperature heat in a process that makes many copies of (amplifies) pathogen nucleic acids present in the blood sample. The results of the test are highly accurate and easily visualized with a simple dipstick that reveals a colored band indicating the presence of the pathogen nucleic acids. The team engineered each component of the in- T cubator for maximum performance, ensuring that the amplification reaction that takes place in tiny test tubes maintains a constant temperature. To achieve this, the group identified a special compound that can store and regulate the heat created by the chemical reaction and can also be easily configured to the tube-holder design, guaranteeing uniform heating on each tube’s surface. When designing the main body of the device, the team used a thermal imaging camera to assess the performance of inexpensive materials, and eventually chose a reusable thermos and cover that minimize system heat loss. The team checked the ability of the NINA incubator to function properly over a range of ambient temperatures. The device maintained the required 140 °C when tested in environments ranging from 50 °C to 90 °C. The group demonstrated that their amplification system provides sensitive and repeatable detection of HIV-1 in just 80 minutes. They are now working to pair their amplification system with a simple technique for preparing nucleic acids from blood samples in the field. The newest version of the incubator produces heat using magnesium iron alloy (MgFe). MgFe was chosen because it costs just USD 0.06 per reaction and can be supplied in a self-contained packet. To start the heatproducing reaction, a technician simply adds saline solution to the packet at the bottom of the thermos. Paul LaBarre, MME, a senior technical officer at PATH and lead author of the study, said, “To complete this low-resource setting diagnostic, one remaining need is the integration of a simple method for isolating nucleic acids from patient blood samples before amplification. Current methods are expensive and technically difficult. Fortunately, there are several methods we are testing that look promising.” The study was published on November 26, 2014, in the journal Public Library of Science ONE. Image: A cut-away view of the reusable NINA device showing relative location of insulation, heat source, phase change material, and samples (Photo courtesy of Paul LaBarre, PATH). LAMP Method Detects Malarial Parasites Using Microwave Irradiation rapid and reliable nucleic acid extraction procedure from human blood and malarial parasites using microwave irradiation as a promising platform has been described. Although microscopy of blood smears is still considered the gold standard for diagnosing malaria infections, microscopy is frequently unable to detect low-density infections and requires skilled expertise. Scientists at the University of Tübingen (Germany; www.uni-tuebingen.de) working with colleague in the Republic of Congo collected venous A LINKXPRESS COM blood samples either into 5 mL heparinized tubes or by finger prick with blood stored on sterile Whatman filter paper at admission to the Albert Schweitzer Hospital (Lambaréné, Gabon; www.schweitzerfellowship.org) from patients suffering from severe Plasmodium falciparum infections. DNA was extracted from whole blood samples as well as from the cultured parasites of the dilution series using the conventional QIAamp DNA mini blood kit based extraction procedure (Qiagen; Hilden, Germany; www.qiagen.com). A tailored LMI-03-15 114 loop mediated isothermal amplification (LAMP) methodology was used that utilized hydroxynaphthol blue (HNB) and Bacillus stearothermophilus (Bst 2.0) DNA polymerases for the molecular detection of malarial parasites. The LAMP assay reactions were performed using two heat blocks (Block Thermostat BT 200, Kleinfeld Labortechnik, Gehrden, Germany; www.kleinfeld-labor.de) and preheated to 60 °C for DNA amplification for 45 minutes, and enzyme inactivation for two minutes at 80 °C. Following microwave irradiation for DNA isolation, conventional polymerase chain reaction (PCR) assays were able to detect up to five malaria parasites/μL. The LAMP methodology was capable to detect as low as one P. falciparum parasite/μL after DNA extraction by microwave irradiation. A turnover time of 45 minutes from nucleic acid extraction to final visual read-out was achieved. The amplicon was visualized through a distinct color change and subsequently confirmed by gel electrophoresis. A change from violet to light sky blue was considered a positive result of amplification. If the reaction remained violet, the sample was assessed as being negative. The authors concluded that the LAMP procedure offers a cheap, simple and fast method of molecular detection of malaria parasites. This test can easily be performed in basic laboratories. The methodology has been validated as a proof of concept and has specifically been developed for use at low-resource settings. Such rapid molecular diagnostic tests may aid health providers to make timely therapeutic interventions in malaria endemic regions. The study was published on November 24, 2014, in the Malaria Journal. LabMedica International February-March/2015 14 LabMedica for daily laboratory medicine news click to www.labmedica.com Gene Expression Correlates with Lymphocyte Infiltration in Breast Cancer ymphocytic infiltration is associated with a favorable prognosis and predicts response to chemotherapy in many cancer types, including the aggressive triple-negative breast cancer (TNBC). A novel high-tech system has been developed for measuring the body’s immune response to cancer as a way of assessing how rapidly the disease is likely to progress. The system combines computerized imaging of tumor samples with statistical analysis, and is the first objective method to measure the interaction between a patient’s immune system and their tumor. Scientist at The Institute of Cancer Research (London, UK; www.icr.ac.uk) analyzed 181 samples from women with triple-negative breast cancer. On average, three tumor sections were obtained from different locations of each primary tumor and placed onto the same slide. Tumor materials sandwiched between these sections were L sectioned, mixed and used for molecular profiling, thereby maximizing the biological relevance of multiple data types being generated. The team developed a system, which split lymphocytes into three classes depending on their location within the tumor, and calculated how many of each type were present in each sample, and how many cancer cells were present. Immune infiltration was scored for 112 of the 181 samples by the pathologists into three categories: absent, mild and severe: absent if there were no lymphocytes, mild if there was a light scattering of lymphocytes and severe if there was a prominent lymphocytic infiltrate. Gene expression data were profiled using the human linkage-12 genotyping beadchip (HT-12) platform (Illumina; San Diego, CA, USA; www.illumina.com). Women with fewer than around eleven intratumor lymphocytes per 1,000 cancer cells had an average five-year survival rate of 49%, compared with an average of 80% in triple-negative breast cancer as a whole. They also found a correlation between immune infiltration of tumors and increased levels of a protein called cytotoxic T-lymphocyte-associated protein 4, (CTLA4) or cluster of differentiation 152 (CD152), suggesting it could be a potential treatment target in this breast cancer type. Yinyin Yuan, PhD, the team leader of the study, said, “Our test combines imaging technology with computerized analysis of large amounts of data from tumor samples, which typically contain more than 100,000 cells. We found the technique could accurately identify high-risk tumors that were evading the body’s immune system in this type of breast cancer, and hope it can be adapted and added to doctors’ arsenal against a variety of cancers.” The study was published on December 10, 2014, in the Journal of The Royal Society Interface. Novel Biomarkers Identified for Incident Coronary Heart Disease etabolic profiling has identified circulating, novel lipid-derived molecules that are associated with future coronary heart disease events, which will enable early diagnosis of cardiovascular disease. The use of used novel biochemical and bioinformatics to identify such biomarkers are not only important for risk stratification and treatment decisions, but can also improve understanding of cardiovascular disease pathophysiology to identify new drug targets. A team of scientists from Karolinska Institutet (Stockholm, Sweden; www.ki.se) and their colleagues at Uppsala University, (Sweden; www.uu.se) performed a mass spectrometry-based non-targeted metabolomics study for association with incident coronary heart disease (CHD) events in 1,028 individuals with 131 events; and a 10-year median follow-up with validation in 1,670 individuals with 282 events and a 3.9 year median follow-up. Metabolomic profiling was performed on the Acquity ultra-performance liquid chromatography (UPLC) apparatus coupled to a Xevo G2 quadrupole time-of-flight mass spectrometer (Q-TOFMS) (Waters Corporation; Milford, USA; www.waters.com) with an atmospheric electrospray interface operating in positive ion mode. Non-consecutive duplicate sample aliquots of 1 μL were injected onto an Acquity UPLC BEH C8 analytical column and mass analysis was performed in the full scan mode. Genotyping arrays used in each study were performed with Illumina Bead chip kits (Illumina; San Diego, CA, USA; www.illumina.com). The metabolomic profiling identified two lipid metabolites, lysophosphatidylcholine and sphingomyelin that reduced the risk of developing coronary heart disease in three Swedish population studies. Another lipid metabolite, monoglyceride, was instead associated with increased risk of coronary heart disease. The study was published on December 11, 2014, in the journal Public Library of Science Genetics. M 15 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 115 LabMedica to read this issue in interactive digital magazine format click to www.LinkXpress.com Rapid Diagnostic Test for Drug Resistant Tuberculosis Reviewed eople suffering from a drug-resistant strain of Mycobacterium tuberculosis, the causative agent of tuberculosis (TB), are more likely to die from the disease, and require treatment with what are described as “second-line” drugs. A rapid and accurate test that could identify people with resistant TB, including a type of TB that is resistant to almost all anti-TB drugs, called extensively drug-resistant tuberculosis (XDR-TB), is likely to improve patient care and reduce the spread of drug-resistant TB. Scientists at the Liverpool School of Tropical Medicine (UK; www.lstmliverpool.ac.uk) have conducted an independent review to examine the diagnostic accuracy of a commercial assay for the detection of resistance to second-line anti-tuberculosis drugs. They reviewed the results from 21 studies, 14 of which reported the accuracy of the specific assay with direct testing, five of which looked at indirect testing, and two of which looked at both. GenoType MTBDRsl (Hain Lifescience GmbH; Nehren, Germany; www.hain-lifescience.de) is the only rapid test that detects resistance to second-line fluoroquinolone (FQ) drugs and secondline injectable drugs (SLID) as well as detecting XDR-TB. MTBDRsl can be performed on TB bacteria grown from sputum, which is called indirect testing and can take a long time, or can be performed immediately on sputum, which is called P direct testing. By indirect testing, the test detected 83% of people with FQ resistance and rarely gave a positive result for people without resistance. In a population of 1,000 people, where 170 have FQ resistance, MTBDRsl correctly identified 141 people with FQ resistance and missed 29 people. Of the 830 people who do not have FQ resistance, the test correctly classified 811 people as not having FQ resistance and misclassified 19 people as having resistance. By direct testing, the test detected 85% of people with FQ resistance and rarely gave a positive result for people without resistance. By indirect testing, the test detected 77% of people with SLID resistance and seldom gave a positive result for people without resistance. In a population of 1,000 people, where 230 have SLID resistance, MTBDRsl correctly identified 177 people with SLID resistance and missed 53 people. Of the 770 people who do not have SLID resistance, the test correctly classified 766 people as not having SLID resistance and misclassified four people as having resistance. By direct testing, the test detected 94% of people with SLID resistance and hardly ever gave a positive result for people without resistance. By indirect testing, the test detected 71% of people with XDR-TB and rarely gave a positive result for people without XDR-TB. In a population of 1,000 people, where 80 have XDR-TB, MTBDRsl correctly identified 57 people with XDR-TB and missed 23 people. In this same population of 1,000 people, where 920 do not have XDR-TB, the test correctly classified 909 people as not having XDRTB and misclassified 11 people as having XDR-TB. Grant Theron, PhD, the lead author of the review, said, “Our review shows that in adults with TB, a positive result for second-line drugs, either fluoroquinolone or injectable, or XDR-TB can be treated with confidence. However, given that a number of people tested negative while having a resistant strain, clinicians may still want to carry out conventional testing in some cases.” The study was published on October 30, 2014, in the Cochrane Review. Image: The GenoType MTBDRsl assay simultaneously detects TB complex and its resistance to first and second line drugs from either culture (solid or liquid) and decontaminated smear positive pulmonary samples (Photo courtesy of Hain Lifescience). Mutations in Rare Asbestos-Caused Cancer Identified by Targeted Next-Generation Sequencing argeted next-generation sequencing, an advanced genomic analysis tool, was used to identify genes linked to the development of the rare cancer malignant pleural mesothelioma (MPM). Malignant mesothelioma is a rare form of cancer that develops from transformed cells originating in the mesothelium, the protective lining that covers many of the internal organs of the body. It is usually T LINKXPRESS COM caused by exposure to asbestos. The most common anatomical site for the development of mesothelioma is the pleura (the outer lining of the lungs and internal chest wall), but it can also arise in the peritoneum (the lining of the abdominal cavity), the pericardium (the sac that surrounds the heart), or the tunica vaginalis (a sac that surrounds the testis). The three-year survival rate for patients with this disease is only 8%, LMI-03-15 116 as most MPM patients are diagnosed with late stage disease with limited therapeutic options. Investigators at the University of Torino (Orbassano, Italy; www.unito.it) used targeted next-generation sequencing (NGS), a method that determines the identity and order of nucleotides in the DNA comprising a specific set of genes rather than sequencing the entire genome, to analyze tumor cells from patients with advanced stage MPM. In this study, a series of 123 formalin-fixed, paraffin embedded (FFPE) tissue samples with clinical annotations was retrospectively tested with the Life Technologies (Carlsbad, CA, USA; www.lifetechnologies.com) Ion AmpliSeq Cancer Hotspot Panel v.2 library kit to investigate 50 genes plus another two, BRCA1 associated protein-1 (BAP-1) and Neurofibromatosis-2 (NF2), frequently altered in MPM. Results revealed that mutations clustered in two main molecular pathways, p53/DNA repair and PI3K/AKT (PI3 kinase/protein kinase B). Certain mutations within the PIK3CA, STK11, or TP53 genes associated with a decreased time to disease progression. Additionally, there was a decrease in the time to disease progression and overall survival when there was an accumulation of multiple mutations. Furthermore, a mutation in the BAP-1 gene correlated with nuclear localization of the BAP-1 protein. The study was published in the December 15, 2014, online edition of the Journal of Thoracic Oncology. LabMedica International February-March/2015 16 LabMedica for daily laboratory medicine news click to www.labmedica.com Molecular Strep A Test Cleared for Cobas System rapid test for the detection of group A streptococcus bacterial (Strep A) DNA in throat swab specimens has been cleared for use in a molecular point of care diagnostic system. The Strep A test achieved outstanding sensitivity aiding healthcare professionals to make immediate, informed treatment decisions in a variety of testing locations and accurate diagnosis of acute infection is necessary to properly treat the disease using appropriate antibiotic therapy. Streptococcus pyogenes (Strep A) is a ubiquitous pathogen that causes a wide range of human infections, including pharyngitis, sinusitis, lymphadenitis, pyoderma, endocarditis, meningitis, septicemia, tonsillitis, impetigo, and upper respiratory tract infections. Strep A is capable of initiating two nonsuppurative complications, acute rheumatic fever and post-streptococcal acute glomerulonephritis, which can have severe negative consequences on the health and wellbeing of infected patients. A The cobas Strep A assay utilizes polymerase chain reaction (PCR) technology and the cobas Strep A test can detect Strep A DNA obtained from throat swab specimens in 15 minutes with the cobas Liat System (Roche; Basel, Switzerland; www.roche.com). The cobas Strep A test is Conformité Européenne (CE) Marked and the US Food and Drug Administration (FDA; Silver Spring, MD, USA; www.fda.gov) has provided 510(k) clearance. The cobas Liat is a compact, fast and easy to use molecular diagnostic system designed for on-demand testing in physician clinics, pharmacy, and hospital laboratory settings. The system includes the cobas Liat Analyzer and growing portfolio of assays, including cobas Influenza A/B and cobas Strep A. Roland Diggelmann, MBA, Chief Operating Officer of Roche Diagnostics, said, “The cobas Strep A test is easy to use and provides accurate results to support a treatment decision in just 15 minutes, much faster than current technologies. It also pro- vides a significant improvement over conventional methods such as culture testing, where patients can wait up to two days to receive their result, or rapid antigen testing where confirmation with culture is needed due to significantly lower sensitivity.” Image: The cobas Liat molecular diagnostic system (Photo courtesy of Roche). Blood Test Identifies Genetic Mutation Responsible for CSID common mutation for congenital sucrose-isomaltase deficiency has been identified in the Inuit population where the condition is highly prevalent. Congenital sucrose-isomaltase deficiency (CSID) is a rare hereditary cause of chronic diarrhea in children and people with this condition lack the intestinal brush-border enzyme required for digestion of di- and oligosaccharides, including sucrose and isomaltose, leading to malabsorption. Scientists at the University of Ottawa (Canada; www.uottawa.ca) and their colleagues isolated DNA from the blood of a child from Baffin Island in Nunavut, Canada’s largest territory, in whom severe chronic diarrhea developed while taking sucrose-containing infant formula. They then sequenced the sucrose-isomaltase (SI) gene in this child to identify the specific genetic mutation responsible for the disorder. The team then genotyped and sequenced 128 anonymized samples from Inuit controls from a range of Canadian Arctic locales on an ABI 3730 DNA Analyzer (Applied Biosystems; Foster City, CA, USA; www.appliedbiosystems.com). Sequencing of the SI gene identified a novel homozygous frameshift mutation in the proband NM_001041.3:c.273_274delAG (p.Gly92Leufs8). From the 128 anonymized samples from Inuit controls they identified a further two homozygous and 40 heterozygous individuals. The observed allele frequency of this mutation in the sample was 17.2% (44 of 256 total alleles). Matthew A. Lines, MD, the senior author of the study, said, “People with CSID may remain asymptomatic unless they consume sucrose, which is why persons consuming a Western diet are more likely to become ill. Timely recognition of this condition and initiation of appropriate therapy is paramount. Our study should prompt physicians to consider CSID and to review the sucrose content of a patient’s diet, and specifically that of infant formula if applicable”. Dr. Lines added that as result of the team’s findings CSID, which formerly required an intestinal biopsy for diagnosis, can now be diagnosed with a simple blood test. The study was published on December 1, 2014, in the Canadian Medical Association Journal. A 17 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 117 PRODUCT NEWS To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page SAFETY WORKSTATION HBA1C SYSTEM Bigneat Caretium Instruments DAS The Optiflow is a small, bench-mounted ductless fume cabinet designed to protect users from chemical vapors, fumes or particles depending on the type of filtration chosen. The workstation offers unrestricted access for procedures that are difficult to perform within a standard fume cabinet. The KH-101 walkaway system offers reliable HbA1c monitoring and results by LC technique. Features highlights include a color touch screen interface, one-step operation, auto sampler of 36 samples, built-in printer, and results available in five minutes. The APE IF ELITE is an ELISA-IFA processor that can master 10 methods on line with 4 ELISA microplates at different temperatures. A 3-needle system allows fast, clean, and clear processing on 20 IFA slides. Key features include sample barcode reader, microplate shaker and camera. LINKXPRESS COM LINKXPRESS COM LMI-03-15 201 AUTOMATED PROCESSOR LMI-03-15 202 LINKXPRESS COM LMI-03-15 203 Neutrophil Motility Reveals Potential Sepsis Biomarker he development of sepsis in patients with major burns may be predicted by abnormal motility patterns of white blood cells called neutrophils, measured through the microscopic channels of a novel device. Since the symptoms of sepsis are similar to those of the systemic inflammation that occurs in almost every serious burn patient, diagnosing sepsis relies on culturing bacteria from the blood, a process that takes 12 to 24 hours. Scientists and bioengineers at the Massachusetts General Hospital (Boston, MA, USA; www.mgh.harvard. edu) took blood samples from patients with large thermal injuries admitted to the Massachusetts General T LINKXPRESS COM Hospital (MGH). Enrolment criteria included burns covering at least 20% of total body surface area, age between 18 and 81, and included in the enrollment were both male and female, proportionally distributed among ethnic groups. Neutrophils were isolated from whole blood by density gradient using the EasySep Human Neutrophil Kit (STEMCELL Technologies Inc.; Vancouver, BC, Canada; www. stemcell.com). A microfluidic devise was assembled to generate chemical gradients in two simple steps performed at the beginning of the study, after which the device does not require any user intervention or external syringe pumps to operate. LMI-03-15 118 The microfluidic devices was made with two layers of photoresist SU8 (Microchem; Newton, MA, USA; www.microchem.com), the first one 3 μm thin and the second one 50 μm thick, were patterned on one silicon wafer by sequentially employing two photolithography masks and processing cycles. The wafer with patterned photoresist was used as a mold to produce polydimethylsiloxane parts, which were then bonded irreversibly to standard glass slides. The team analyzed the ability of neutrophils from blood samples of 13 patients with serious burns, collected several times during their treatment, to move through the device when it was primed with one of two chemical attractants or with saline solution, and compared it with the movement of cells from three healthy volunteers. Neutrophils from healthy individuals moved quickly and efficiently through the device toward a chemical attractant, easily navigating around corners and posts, while cells from burn patients showed limited, slower and poorly organized movement toward the chemical signal. This movement of neutrophils in the absence of chemical signals was observed in samples taken from some patients several days before a diagnosis of sepsis could be made, and once effective antibiotic treatment began, the unusual movement pattern began to fade. Daniel Irimia, MD, PhD, a leading author of the study said, “Since only a handful of rare genetic disorders affect neutrophil function, it has long been assumed that studying these cells was not important; but our findings indicate that neutrophils play a much more important role in sepsis than has been appreciated. We’re also working to expand this investigation to other patients at risk for sepsis, to see if the findings from burn patients have broader application.” The study was published on December 9, 2014, in the journal Public Library of Science ONE. Image: The development of sepsis in patients with major burns may be predicted by abnormal motility patterns of white blood cells called neutrophils, measured through the microscopic channels of this device invented by MGH researchers (Photo courtesy of BioMEMS Resource Center, Massachusetts General Hospital). LabMedica International February-March/2015 18 LabMedica for daily laboratory medicine news click to www.labmedica.com Familial Glioma Linked to Mutation In Telomere Protection Gene utations in the POT1 (protection of telomeres protein 1) gene have been linked to the development of brain tumors in families with two or more members suffering from glioma, the most common form of primary brain cancer. The POT1 gene is a member of the shelterin complex and encodes a nuclear protein involved in telomere maintenance. Specifically, this protein functions as a member of a multiprotein complex that binds to the TTAGGG repeats of telomeres, regulating telomere length and protecting chromosome ends from illegitimate recombination, catastrophic chromosome instability, and abnormal chromosome segregation. A recent paper described a study that was conducted under the auspices of the Gliogene Consortium (Houston, TX, USA; http://gliogene.org), a collaborative group of familial brain tumor researchers from the United States, the United Kingdom, Sweden, Denmark, and Israel. Between 2007 and 2011 The Gliogene Consortium recruited 435 families in which glioma occurred in multiple family members. Overall, it has been estimated that approximately 5% of brain tumors are familial. Whole exome sequencing (which determines the DNA sequence of the exons, or protein-coding regions, of tens of thousands of genes simultaneously) was performed on samples taken from 90 individuals with glioma from this group. Results identified two families presenting with mutations in POT1 that were shared by both affected individuals in each family. Validation in a separate cohort of 264 individuals from 246 families identified an additional mutation in POT1. In one family, six members carried a POT1 mutation that is rarely found in normal populations, and among them three developed glioma. In another family, six individuals carried a different POT1 gene mutation and two developed glioma. At the molecular level the POT1 mutations were predicted to impact DNA and TPP1 binding. TPP1 normally interacts with POT1 and regulates its function. When telomeres are to be lengthened, TPP1 is a central factor in recruiting telomerase to telomeres. “I have been researching familial glioma for nearly 30 years, and this study is really the first time we have had a hit when it comes to identifying a gene that is potentially associated with predisposition to the disease,” said senior author Dr. Melissa Bondy, professor of medicine at Baylor College of Medicine (Houston, TX, USA; www.bcm.edu) and principal investigator of the Gliogene Consortium. “It is widely thought amongst the clinical community that there is no association between family history and development of glioma. Because we know very little about the contributing genetic factors, when cases occur in two or more family members, it is viewed as coincidental,” said Dr. Bondy. “By understanding more about the genetic link, we hope that one day we can improve treatments and preventive strategies for those with a family history of glioma.” The study will be published in the January 2015 online issue of the Journal of the [US] National Cancer Institute. M Image: Brain tumors are hereditary in some cases, and now a gene mutation has been identified as the culprit (Photo courtesy of Shutterstock). 19 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 119 PRODUCT NEWS To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page DIAGNOSTIC TEST ESR ANALYZER DiaSys Diagnostic Systems Horron XLH Medical Electronics Kehua Laboratory System The CRP IS test offers a wide measuring range for whole blood samples, as well as for plasma samples. The test is designed for use on the InnovaStar, a small clinical chemistry analyzer for single samples, intended for use at the point of care in small labs. The ORON-200 features multicolor touch screen operation, and intelligent software. The system includes 40 channels, a throughput of up to 80 tests per hour, and it can display and print out the ESR curve. An optional barcode reader can also connect to LIS. The ZY-1200 is a fully automatic, open system features 180 sample positions, 200 reagent positions, and 160 reaction positions. The system offers user-friendly software, and is designed for a high throughput of 800 photometric tests per hour, and 1,200 tests per hour with ISE. LINKXPRESS COM LMI-03-15 204 LINKXPRESS COM LMI-03-15 205 AUTO CHEMISTRY ANALYZER LINKXPRESS COM LMI-03-15 206 Clinically Significant Yeasts Identified by MALDI-TOF MS Systems he performance of two matrix-assisted laser desorption/ionization time-of-flight mass spectrometry systems (MALDI-TOF MS) has been evaluated for the identification of clinically significant yeast isolates. The rapid identification of pathogenic yeast species is helpful to start timely and effective antifungal therapy and this rapid identification can narrow the spectrum of therapeutic options, conceivably prevent treatment with toxic antifungal agents, improve the outcome, and reduce costs. Microbiologists at Kuwait University (Safat, Kuwait; www.kuniv.edu) collected a total of 188 clinically relevant fungal isolates obtained during one year of routine laboratory processing of clinical laboratory in a local hospital. The isolates were obtained from blood culture, bronchoalveolar lavage, cerebrospinal fluid, urine, wound, and high vaginal and endocervical swabs. The identification of the clinical yeast isolates was initially achieved by VITEK 2 system (bioMérieux; Marcy l’Etoile, France; www. biomerieux.fr). When necessary, one or more tests were also performed, morphology on Sabouraud dextrose agar (SDA), germ tube test for T Candida species, and urease assimilation test for Cryptococcus species (Becton, Dickinson and Company; Sparks, MD, USA; www.bd.com). Protein was extracted from the isolates and analyzed on MALDI-TOF Bruker MS (Bruker Biotyper, Bruker Daltonics; Bremen, Germany; www.bruker.com) and bioMérieux MALDI-TOF VITEK MS. Accurate identification by VITEK 2 was 94.1% (177/188), by VITEK MS 93.0% (175/188), and by Bruker Biotyper MS 92.6% (174/188). Three isolates were not identified by VITEK MS, while nine Candida orthopsilosis were misidentified as C. parapsilosis, as this species is not present in its database. Eleven isolates were not identified or were wrongly identified by Bruker Biotyper and although another 14 were correctly identified. The authors concluded that MALDI-TOF MS methods provide a standardized working protocol for the identification of yeasts from clinical specimens. The short turn-around time and expandability of the database demonstrate that this is a suitable first-line test for the identification of yeasts in the routine clinical microbiology laboratory. The study was published in the September 2014 issue of the International Journal of Infectious Diseases. Image: The VITEK MS, a MALDI-TOF mass spectrometry system designed for rapid microbial identification (Photo courtesy of BioMérieux). Atypical Chronic Lymphocytic Leukemia Identified by Digital Microscopy igital microscopy has been used to morphologically classify chronic lymphocytic leukemia (CLL) patients as atypical chronic lymphocytic leukemia (aCLL) or typical CLL (tCLL), and determine the prevalence of prognostic markers in each group. In tCLL, which are approximately 80% of all cases, over 90% of the circulating lymphocytes are small-to-medium sized with relatively normal morphology, except for a characteristically clumped, chunky chromatin pattern. Scientists at the Memorial Sloan Kettering Cancer Center (New York, NY, USA; www.mskcc.org) evaluated the lymphocyte morphology on archived blood films of 97 CLL patients, and results of their D prognostic marker analysis at diagnosis were obtained between January 2010 and December 2011. All patients included had a confirmed diagnosis of CLL; availability of results for complete blood count, immunophenotyping, immunoglobulin heavy chain V-III region VH26 (IgVH) mutation status, and fluorescence in situ hybridization (FISH) for trisomy 12 and deletions of 13q14, 6q, 17p (tumor protein 53, TP53), and 11q (ataxia telangiectasia mutated, ATM); and an archived peripheral blood film. The age of the archived blood films varied between 8 and 26 months. The archived Romanowsky-stained blood films were reexamined using the Cellavision AB digital im- aging system (Lund, Sweden; www.cellavision.com). Additional lymphocyte subtypes were created within Cellavision for manual subclassification of variant forms seen in aCLL including prolymphocyte, large atypical lymphocyte, and cleaved lymphocyte. The team found that 27% of patients with CLL in their study were morphologically classified as aCLL, similar to that reported in the literature. The aCLL group had a higher prevalence of trisomy 12, unmutated IgVH, and cluster of differentiation 38 (CD38) expression markers associated with poor prognosis. The study was published in the August 2014 issue of the International Journal of Laboratory Hematology. LabMedica International February-March/2015 20 LabMedica for daily laboratory medicine news click to www.labmedica.com Immunochromatographic Strip Endorsed for α-Thalassemia Screening halassemia is an autosomal recessive inherited genetic disorder of the red blood cells causing by reduction or absence of one or more globin chains of hemoglobin (Hb) molecules. An immunochromatographic (IC) strip test has been developed for rapid screening of α0-thalassemia by testing for Hb Bart’s in blood samples using a specific monoclonal antibody against Hb Bart’s. Molecular Bioscientists at the Mahidol University, Nakhonpathom, Thailand; www.mahidol. ac.th) working with their Australian colleagues, collected a total of 662 routinely leftover anticoagulated blood samples, 411 from Thailand and 251from West Australia and included in a multicenter study. Hematologic data were determined T Zinc Isotope Test Helps Detect Early Breast Cancer by the automatic blood cell counters being operated at individuals laboratory collaborated in this multicenter study. Polymerase chain reaction (PCR) was used to identify α0-thalassemia, α+-thalassemia, Hb H disease and non-deletion α-thalassemia in most samples. In two laboratories α-thalassemias were detected by the presence of erythrocyte Hb H inclusion bodies using the enriched young red cells from just below the buffy coat. A modified Alpha Thal IC strip test (i+MED Laboratories, Bangkok, Thailand; www.imed.co.th) for screening of αthalassemia was also tested. There were 45 samples with α-thalassemia traits and were demonstrated to have the α0-thalassemia gene, 18 were from Hb H and EA Bart’s disease patients, and 15 were homozygous α+-thalassemia or compound heterozygous α+-thalassemia and non-deletion α-thalassemia. All of these samples showed strongly positive results with IC strip test except for two α0-thalassemia samples, which had the negative results and were accounted for as false negatives. Among the 180 samples with normal α-globin genotyping the IC strip test revealed 97.8% negative reactivity. The authors concluded that in combination with red blood cell indices, the IC strip test could rule out mass populations for further α0-thalassemia detection by PCR-based analysis. The established IC strip test has an advantage since it does not require sophisticated equipment, easy to perform and the result can be visually interpreted without an expert. It is also less-time consuming and can be done with a large number of samples, and therefore the IC strip test can be applied in thalassemia screening program, which will reduce the need of expensive PCR methods in the inappropriate cases for diagnosis of α0-thalassemia carriers. The study was published on November 6, 2014, in the journal Translational Research. t may be possible to detect the early signs of breast cancer with a test that measures changes in zinc isotopes as measurable changes in zinc isotope composition can be detected in breast tissue and could be used as a biomarker for early breast cancer. Breast cancers that are found after they start to cause symptoms, for example, a new lump or swelling, or changes in nipple shape and texture, are usually larger and more likely to have started spreading than breast cancers found before symptoms emerge. The size of a breast tumor and how far it has spread are two of the most important factors in predicting the success of treatment and the longer-term outlook for the patient. Scientists at the University of Oxford (UK; www.ox.ac.uk) determined the zinc concentrations and isotopic composition of blood and blood serum of healthy controls and breast cancer patients, alongside a suite of 10 breast tissues, predominantly obtained from breast cancer patients. They applied techniques normally used by earth scientists to understand climate change and the birth of planets, to study how the body processes metals. Zinc and copper concentrations were determined by multiple collector inductively coupled plasma mass spectrometry (MC-ICP-MS) and inductively coupled plasma atomic emission spectroscopy (ICPAES). Isotope analyses were performed using the Nu Instruments Nu Plasma HR MC-ICP-MS at the appropriate resolution mode (Copper: low, Zinc: medium) with either an Aridus (Cetac; Omaha, NE, USA; www.cetac.com) or a desolvating sample system (DSN) (Nu Instruments, Oxford, UK; www.nu-ins. com). The reproducibility of the methods was monitored by repeat measurements of an in house standard alongside sample. The investigators found that the breast cancer tumors had a significantly lighter zinc isotopic composition than the blood, serum and healthy breast tissue of both the breast cancer patients and the healthy controls. The team suggests the subtle differences in zinc composition occur because tumor cells process the metal differently to normal cells. They also found similar changes in copper in one of the breast cancer patients. The study was published on December 1, 2014, in the journal Metallomics. I 21 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 121 PRODUCT NEWS To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page COAGULATION MONITOR CHEMISTRY ANALYZER Microvisk URIT West Medica The CoagMax POC PT/INR monitor is designed to make coagulation as simple to perform as blood glucose testing. Key features include enhanced SmartStrip technology, easy connectivity with a supplied USB cable, and all necessary QC operations are done by the meter itself. The URIT-8021A features durable syringes to ensure accuracy and precision, along with an autowashing system to reuse cuvettes. Other benefits include automatic stop/alarm, liquid level protection, collision protection, and a throughput of 200 tests per hour. The Vision Hema Pro is a blood cell identification and preclassification solution designed for smalland medium-sized labs. The system offers quick validation of results, morphology analysis, and scanning series of slides without the constant presence of the operator. LINKXPRESS COM LMI-03-15 207 LINKXPRESS COM LMI-03-15 208 IMAGE ANALYSIS SYSTEM LINKXPRESS COM LMI-03-15 209 Nose and Throat Specimens Compared For Rapid Adenovirus Detection he diagnosis of adenovirus infection on clinical grounds alone is sometimes difficult and now chromatographic immunoassay tests have begun to be available for point-of-care use. Adenovirus is among the most common causes of upper respiratory tract infections in febrile pediatric outpatients throughout the year and rapid, accurate diagnosis is important because adenoviral diseases are often associated with prolonged, high-grade fever. Scientists at the Hiroshima Prefectural Technology Research Institute (Japan; www.pu-hiroshima.ac.jp) conducted a prospective study between September 2008 and July 2012 to determine whether nasopharyngeal aspirate (NPS) and throat swab (TS) specimens from individual patients could be compared with regard to usefulness for adenovirus detection. One pediatrician collected TS and NPA specimens in parallel from outpatient children suspected of having adenovirus infection and performed the rapid diagnosis using a chromatographic immunoassay test, the ImmunoAce Adeno (TAUNS Laboratories, Inc.; Numazu, Japan; T www.imunoace.jp). TS and NPA were tested in separate identical devices and each NPA swab was prepared after being dipped in NPA fluid. Aliquots of NPAs were stored at -70 °C until tested with culture and real-time polymerase chain reaction (PCR) assays to detect and identify adenovirus. Among the 309 children enrolled, real-time PCR assay, which did not distinguish among serotypes, identified 153 patients with adenovirus and these were considered to be adenovirus-infected patients. Of these 153 patients, viral cultures identified 139 patients with adenovirus, including six serotypes, accounting for 90.8% of the adenovirus detection rate. Among the 153 adenovirus-positive specimens, based on real-time PCR findings, the sensitivities of the rapid test ImmunoAce Adeno were 91.5% for TS and 90.8% for NPA. The authors concluded that the diagnostic accuracy between TS and NPA specimen types for the rapid diagnosis of adenovirus infections, and the detection rates between the two specimen types were nearly equivalent. Throat swabs are commonly used for the rapid diagnosis of adenoviral infections, while NPAs are routinely used for rapid detection of influenza virus. The present findings will be helpful for pediatricians in primary care clinics because they may be able to use the remaining NPA specimen for the detection of adenovirus or other respiratory viruses in cases when an influenza-negative result is unexpectedly obtained. The study was published on November 12, 2014, in the journal Diagnostic Microbiology and Infectious Disease. Image: The ImmunoAce Adeno, an Adenovirus antigen detection kit (Photo courtesy of TAUNS Laboratories). Gene Uncovered Associated with Aggressive Breast Cancer biomarker has been identified that is strongly associated with triple negative breast cancer (TNBC), a highly aggressive carcinoma that often has early relapse and metastasis following chemotherapy. TNBC is characterized by tumors that do not express estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (HER2), and represents the most aggressive subtype of breast cancer, with a high rate of relapse and no available therapeutic targets. Scientists at the ASTAR Genome Institute (Singapore; www.gis.a-star.edu.sg) used quantitative polymerase chain reaction (qPCR) and western blotting for micro ribonucleic acid (miRNA) profiling of breast cancer cells and quantitative real-time PCR A for validation. Total RNAs were isolated and purified with the miRNeasy Mini Kit (Qiagen; Venlo, The Netherlands; www.qiagen.com). The miRNA expression array hybridization was performed using the Human miRNA Microarray Kit V3 (Agilent, Santa Clara, CA, USA; www.agilent.com), and data analysis was performed. Immunohistochemistry was also implemented. The team found that small RNA, often called microRNA, is lost in highly metastatic TNBC cells but not in luminal breast cancer. As a result, the gene RAS Protein Activator Like 2 (RASAL2), which is negatively regulated by this microRNA, is upregulated in a set of TNBC tumors. The study showed that TNBC patients whose tumors have high expression of RASAL2 tend to have a lower survival rate as compared to patients whose tumors have low levels of this gene. Additionally, the study showed that genetic knockdown of RASAL2 gene can lead to reduced metastasis in breast cancer mouse model. Qiang Yu, PhD, a professor and project leader of the study, said, “Cancer is an extremely heterogeneous disease, where many molecular processes have gone wrong in their own ways. Rather than a tumor suppressor, we show here that RASAL2 actually acts as a cancer-promoting molecule in TNBC. This reminds us that the same molecule can function very differently in different subtypes of cancers, a phenomenon which has often been seen before.” The study was published on November 10, 2014, in the Journal of Clinical Investigation. LabMedica International February-March/2015 22 LabMedica for daily laboratory medicine news click to www.labmedica.com High-Tech Microscope Offers Lower Cost Alternative he direct visualization of cells for the purpose of studying their motility has typically required expensive microscopy equipment; however, recent advances in digital sensors mean that it is now possible to image cells for a fraction of the price of a standard microscope. The development and performance of an expandable cell motility system has been described that employs inexpensive, commercially available digital Universal Serial Bus (USB) microscopes to image various cell types using time-lapse and perform tracking assays. Scientists at Brunel University (Uxbridge, UK; www.brunel.ac.uk) constructed the apparatus from cheaply bought materials. Various lighting sources were tested, and ultimately a light-emitting diode (LED) strip desk lamp was selected. An incubation chamber was developed to fit over the top of the stage and the chamber was made from transparent acrylic to allow visualization inside. The three microscopes used were identical models (VMS-004D, Veho; Southampton, UK; www. veho-uk.com) in order to prevent any discrepancies. These microscopes use a complementary metal–oxide–semiconductor (CMOS) image sensor with 1.3 megapixel resolution. Magnification has two set lev- T els, from approximately ×20 minimum to around ×400 maximum, achieved using a focusing wheel. To enhance stability, magnification and to allow for observation of live samples in liquid (cells) the microscopes were inverted. The imaging capability of the system was compared to a conventional inverted microscope fitted with a 1.3-megapixel camera. The highest magnification on the conventional microscope was greater than the constructed system, but the maximum pixel resolution of images was the same. Spatial resolution on the conventional microscope was higher and intracellular detail could be seen at the highest magnification that could not be distinguished in the innovative system when images were enlarged to match the size. The authors concluded that the novel cell tracking system had the ability to perform multiple simultaneous time-lapse studies on various cell types. Due to its low-cost, portability and commercially available components they believe that this system has the potential to enable time-lapse studies by non-specialist departments, and may be a practical solution for scientists with limited financial resources. The study was published on August 14, 2014, in the journal Public Library of Science ONE. Image: Adam Lynch created his own inverted microscope by adapting a cheap instrument he bought online to save himself time and money (Photo courtesy of Brunel University London, College of Health and Life Sciences). Simple Breath Test Aids Type 1 Diabetes Early Diagnosis chemical marker has been identified for type 1 diabetes in the breath of children who are unaware they have the condition until they develop diabetic ketoacidosis, a potentially life-threatening complication and a breath test could pave the way to allow early diagnosis. The symptoms of the diabetes mellitus type 1, which include increased thirst and urination, fatigue and weight loss, can be mistaken for symptoms of other disorders and some cases where type 1 diabetes is misdiagnosed in children. A recent study found that between 2001 and 2009, incidence of type 1 diabetes among children aged less than 9 years rose by 21%. Biochemists at the University of Oxford (UK; www.ox.ac.uk) collected breath samples from 113 children and adolescents aged 7 to 18 years that had been diagnosed with type 1diabetes. The team measured levels of acetone and another ketone called isoprene in the participants’ breath and compared them with ketone and glucose levels in the blood, measurements of which were taken at the same time as breath samples were collected. The patients blew through a tube and a bacterial filter into a specially constructed 100 mL syringe, which had the aim of ensuring that the gases collected were end tidal. The sealed bags were analyzed by means of a soft-ionization mass spectrometer (V & F Airsense; Absam, Austria; www. vandf.com). Acetone, isoprene and carbon dioxide concentrations were measured, with the instrument standardized for its sensitivity to these compounds by using previously calibrated gas samples. Each patient provided blood for an HbA1c measurement and had capillary blood glucose and hydroxybutyrate (BHB) levels measured using a FreeStyle A 23 LabMedica International February-March/2015 Optium meter (Abbott, Maidenhead, UK; www. abbottdiabetescare.co.uk). The investigators found increased levels of acetone in the breath of the participants who also had increased levels of a ketone called β hydroxybutyrate in their blood. The team found a weak association between increased breath acetone and increased blood glucose but concluded that single breath measurements of acetone do not provide a good measure of blood glucose levels in this cohort. The team has already produced a prototype of a small hand-held device to measure ketone levels in the breath, which is currently being tested in LINKXPRESS COM clinical trials. Gus Hancock, PhD, a professor of chemistry and a senior author of the study said, “Our results have shown that it is realistically possible to use measurements of breath acetone to estimate blood ketones. If the relationship between breath acetone and blood ketone levels is true at higher levels of ketones, a simple breath test could assist with the management of sick days in children with diabetes, preventing hospital admissions by providing a warning of the possible development of diabetic ketoacidosis (DKA).” The study was published on November 25, 2014, in the Journal of Breath Research. LMI-03-15 122 PRODUCT NEWS To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page CLIA SYSTEM FIA METER SNIBE Wondfo Biotech Abbott The Maglumi 800 features three modes of operation, sample loading for up to 40 sample tubes, continuous loading, STAT available, and LIS connection. The system offers a wide test menu, with a throughput of up to 180 tests per hour with first results available in only 17 minutes. The Finecare FIA meter is designed to provide reliable and quantitative results of various kinds of analytes in human blood or urine within several minutes. With a 10 test item menu, it can help diagnose conditions such as cardiovascular disease, renal injury, cancers, and more. The IRIDICA platform can identify more than 1,000 infection-causing pathogens in less than six hours versus the current standard of care, which can take days. By identifying the cause of infections faster, physicians can improve treatment with an earlier diagnosis for critically ill patients. LINKXPRESS COM LINKXPRESS COM LMI-03-15 210 LMI-03-15 211 LINKXPRESS COM LMI-03-15 212 New Diagnostic Test For Pancreatic Cancer S TOR Y IBU APPL R T O DIS ED T IT INV Your Source for Sterilization Accessories THERMO RESISTANT GLOVES Up to 37 cm in length STERILIZABLE INSTRUMENT & WORK-SURFACE MATS TURBO TURBO WASHING WASHING MACHINES MACHINES TRAYS TRAYS Thermo-Resistant (-60 °C to 300 °C) Fully Washable & Flexible Suitable for central sterilization services Sterilizable Heavy Silicone Cover & Transport Tablet MICRO MICRO INSTRUMENT INSTRUMENT MAT MAT SILICON SILICON INSTRUMENT INSTRUMENT MAT MAT Front WASHING WASHING TRAYS TRAYS MAT MAT Front DISEASE TESTING PLATFORM WASHING WASHING TRAYS TRAYS MAT MAT Back NEW! Back Front NEW! SILICONE SILICONE TABLET TABLET AND AND STEEL STEEL COVER COVER NETS NETS Back SILICONE SILICONE WASHING WASHING MAMACHINE CHINE TRAY TRAY & & TABLET TABLET Exchangable Net STERILIZABLE STERILIZABLE WORK-SURFACE WORK-SURFACE MATS MATS Exchangable Nets 100% Silicone Size: 2400 x 1200 mm (3 mm thick) VICOTEX S.A. Place de la Gare 1 • 1009 Pully • Switzerland Tel: (41) 21-728-4286 • Fax: (41) 21-729-6741 E-Mail: [email protected] panel of microRNA (miRNA) biomarkers was assembled from the pool of miRNAs present in the blood of most pancreatic cancer patients that may serve as a diagnostic tool and an indicator of the disease’s aggressiveness. Pancreatic cancer is the fourth most common cause of cancer death in the Western world. The prognosis is poor, with one- and five-year survival rates of only 20% and 6%, respectively. Therefore, markers of the disease that could help with early diagnosis are needed to improve the prognosis. Statistics from the [US] National Cancer Institute (Bethesda, MD, USA; www.nci.nih.gov) show that only about 6% of people with pancreatic cancer survive more than five years after diagnosis. In 2013 an estimated 45,220 new cases of pancreatic cancer were expected to be diagnosed with more than 38,460 of the cases being fatal. MiRNAs are snippets of about 20 nucleotides that block gene expression by attaching to molecules of messenger RNA (mRNA) in a fashion that prevents them from transmitting the protein synthesizing instructions they had received from the DNA. Investigators at Indiana University (Indianapolis, USA; www.iupui.edu) determined miRNA levels in blood or bile obtained from 215 patients with pancreatic ductal adenocarcinoma (PDAC) or from controls. Panels were derived from the differential expression of 10 candidate miRNAs in the samples. MiRNAs that had excellent accuracy for inclusion in regression models were selected. Total A RNA was isolated from samples using Trizol-LS (Life Technologies; Carlsbad, CA, USA; www.lifetechnologies. com). Complementary DNA was generated using 10 ng of RNA in conjunction with miRNA-10b, -21, -30c, -106b, -132, -155, -181a, -181b, 196a, -212, or -425-5p reverse transcription primers and a miRNA reverse transcription kit (Life Technologies). Quantitative PCR was performed for each miRNA using Taqman (Life Technologies) miRNA expression assay reagents. Results revealed that increased expression of miRNA-10b, -155, and 106b in plasma appeared to be highly accurate for diagnosing pancreatic cancer. Senior author Dr. Murray Korc, professor of cancer research at Indiana University, said, “This is a new finding that extends previous knowledge in this field. The key new feature here is that there is a panel of microRNAs that can be measured accurately in the plasma component of blood to determine if a patient has pancreatic cancer. It may be possible to use a blood test to screen individuals who are at high risk for developing pancreatic cancer. We are planning to conduct such studies. It will be important to identify additional markers and to assess how useful a panel of such markers would be for the early diagnosis of this cancer. Based on our findings, this test could also be useful to differentiate between pancreatic cancer and chronic pancreatitis.” The study was published in the October 28, 2014, online edition of the American Journal of Gastroenterology. Vicolab.TradeMed.com LINKXPRESS COM LMI-03-15 124 LabMedica International February-March/2015 24 Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA) IFCC members may send news to: Tahir Pillay MBChB, PhD, Head, Dept of Chemical Pathology, Faculty of Health Sciences, University of Pretoria, Private Bag Bag x323, Arcadia, 0007, South Africa Tel: (27) 12 319-2116; Fax: (27) 328 6000; Email: [email protected] NEWS New IFCC Leadership Team Takes Helm for 2015-17 Term by Prof. Tahir Pillay, e-NewsLetter Editor he new IFCC Executive Board took office in Jan 2015. Members of the Board are as follows: Maurizio Ferrari, President; Graham Beastall, Past President; Sergio Bernardini, Secretary; Tomris Ozben, Treasurer; Rolf Hinzmann, Corporate Representative; Daniel Mazziotta, Member; Rosa Sierra-Amor, Member; Vanessa Steenkamp, Member. The first two months of this year have been extremely busy for the board with the first meeting having taken place in Milan, at the IFCC office, on January 30-31. The Board addressed a large number of routine and special items and approved the Strategic Objectives for the triennial period 2015-2017. T New IFCC President: Prof. Maurizio Ferrari Maurizio Ferrari (MD) is Full Professor of Clinical Pathology, University Vita-Salute San Raffaele, Director of Clinical Molecular Biology and Cytogenetics Laboratory, and Head of Genomic Unit for the Diagnosis of Human Pathologies, Division of Genetics and Cell Biology, IRCCS San Raffaele (Milan, Italy). He received his Degree in Medicine at the Milan University, is specialized in Pediatrics, Hematology and Medical Genetics. He was a postdoctoral fellow at Hospital Paul Brousse, Villejuif, Paris and Honorary Registrar in Hematology at UCH, London. He was Scientific Coordinator of Clinical Research, IRCCS H San Raffaele, Milan (1996-1999), Chairman of Committee on Clinical Molecular Biology Curriculum of IFCC (2002-2007), member of the Education and Management Division of IFCC (2008-2011). He was Chairman of the Education and Management Division of IFCC (2012-2014), member of IFCC Task Force on Pharmacogenetics (from 2008), advisor of CLSI Committee on Molecular Methods. He is Dean of Master’s Degree in Molecular and Cellular Medical Biotechnology (2008 to present) and President of the European Society of Predictive Medicine (2009 to present). In 2004, he received the IFCC-Abbott Award for Significant Contributions in Molecular Diagnostics. His scientific interests are oriented mainly on molecular diagnostic methods, nucleic acids circulating in maternal plasma and molecular studies of several genetic diseases. He developed methods for DNA analysis such as multiplex PCR and capillary electrophoresis, also in a temporal thermal gradient, set up a method involving the ligase chain reaction (LCR) and developed a new method known as double gradient DGGE (DG-DGGE) for the identification of unknown mutations. In the last 4-5 years he has focused his research activity on the detection of fetal DNA in maternal plasma for noninvasive prenatal diagnosis and for diagnostic application in the genetic and oncology field. At present, his research is focused on the Cont’d on page 26 25 LabMedica International February-March/2015 Maurizio Ferrari President Graham Beastall Past President Sergio Bernardini Secretary Tomris Ozben Treasurer News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information NEWS New IFCC Leadership Team Takes Helm for 2015-17 Term Cont’d from page 25 development of diagnostic tests with the application of the next generation sequencing. He is author of 849 publications: peer reviewed journals: 246; other journals: 67; books: 1; book chapters: 45; as well as 490 abstracts at international and national congresses. Total I.F. 1113, 83; h-index:42 (scholar Google); citations: 8846; i-10 index:131. Position statement of Prof. Ferrari In the future, it is vitally important that IFCC continues to support the following existing programs: To increase scientific credibility by adding new task forces and by increasing the activities of the different divisions; To link laboratory medicine strongly to patient healthcare; To improve the globalization of laboratory medicine by increasing the activities both in developed and developing countries; To be globally active by establishing new collaborations with international organizations and by supporting international and regional congresses, i.e., through the Visiting Lecturer Program; To have a clear and watchful financial management. I strongly believe that new IFCC initiatives should focus on: Increasing effort in the different activities in the developing countries; Adding new developing countries to IFCC; Improving the quality standards of laboratory medicine all over the world; Starting new activities in the advanced technological areas; Increasing the relationships of IFCC with clinical organizations to establish a leading role in personalized medicine; Adding new connections to international organizations to increase the leadership in the quality of laboratory medicine and to have a greater recognition of the clinical value of our profession; Increasing IFCC income in order to increase the services and support to its members and Regional Federations. Executive Board’s strategic direction The Executive Board work focused on the possible projects for the next three years: The result of this effort is being organized in the IFCC Strategic Plan 2015-2017, that will be the guideline of all IFCC activities in the next triennial period. Representatives of Regional Members have been invited to participate and contribute to the definition of IFCC priorities. Invitation: COLABIOCLI 2015 (Quito, September 24-26) by Dr. Maria del Carmen Pasquel, President, Organizing Committee he Organizing Committee of the 22nd Latin American Congress of Clinical Biochemistry and Laboratory Sciences and the Ecuadorian Society of Clinical Biochemistry “SEBIOCLI” cordially invites all professionals working in Clinical Laboratory Sciences to attend the conference in Quito, from September 24–26, 2015. T Pre-Congress Advanced Techniques of Analytical Quality – Sponsor: Fundacion Wallace Coulter y AACC; September 22-23, 2015; JW Marriott Hotel Marriott, Quito; Time: 09:00-18:00; Capacity: 50 Professionals; Biomarkers in Cardiovascular Diseases and Brain Vascular: Risk Factors – Sponsor: Fundacion Wiener – LAB; September 22-23, 2015; Colegio de Químicos y Bioquímicos Farmacéuticos de Pichincha “CQBFP”, Quito; Time: 09:0018:00; Capacity: 50 Professionals; LINKXPRESS COM 5 Courses during the Congress: (1) Hematology (07:00-10:00); (2) Preparation of internal auditors for management system; (3) Instrumental control program quality control phase pre-analytical; (4) Celiac disease; (5) New concepts, diagnosis and immune diseases – Date: Thursday, Friday and Saturday September 24-26, 2015, JW Marriott Hotel, Quito; Time: 07:00-09:00; Capacity: According to room capacity. practice. Date: September 24-26, 2015; Hotel JW Marriott, Quito; Time: 09:15-18:00 ExpoLab Participants will have at their disposal the technological support of their work by the direct communication of their requirements to representatives of top international brands in equipment, reagents, and technology for the clinical laboratory, who will attend the Con- Congress Symposiums, conferences, round tables and plenary sessions covering different topics related to clinical laboratory science current scientific interest, discussed by professionals, scientists and researchers, Europeans and Americans who together with national exhibitors will make this scientific event will be presented efficient support and quality for your LMI-03-15 126 gress COLABIOCLI 2015. Quito, Capital of Equador Quito is a World Heritage Site in 1978 for its architectural beauty in the Baroque art, has a constant spring climate. Its colonial town encloses culture, beauty and history. Ecuador is a small country which is biodiverse, multicultural, multi-ethnic and has four worlds for you to enjoy and move in. Quito and Ecuador await you! Invitation: 4th Congress of the African Federation of Clinical Chemistry (AFCC) Victoria Falls, Zimbabwe (April 28-30, 2015) by Vanessa Steenkamp, Chair, AFCCLabMed 2015, Past-President, AFCC ear Colleagues, as Chair of the Conference Organizing Committee (COC), I would like to invite you to the 4th Biennial Conference of the African Federation of Clinical Chemistry (AFCC), hosted by the Association of Clinical Biochemistry Zimbabwe (ACBZ). The conference will be held during April 28-30, 2015, in Victoria Falls. The theme for the conference “Integrating Clinical Chemistry and Laboratory Medicine in Evidence Based P4 Medicine” is very appropriate as it encompasses the Preventive, Predictive, Personalized and Participatory aspects of Medicine all of which are essential to improve patient care. The Scientific Committee is planning a diverse program with lectures by many eminent speakers from the continent and globally. I believe that this will be a great opportunity for the participants to have formal and informal mutual communication from other countries, pertaining to the most recent advances in the various exciting fields of clinical biochemistry. I trust that participants from all AFCC Member Countries will attend, to en- D sure togetherness in the pursuit of our common goal in ensuring the advancement of clinical chemistry and laboratory medicine on our continent. I hope that you will take this opportunity to visit the breathtaking sights, and enjoy the warm Zimbabwean spirit of friendship from this conference. We look forward to welcoming you to this event. Pre-Congress Courses, Harare 21-24 April 2015 Quality Laboratory Management, Genomics and Proteomics, Metabolics-Informatics “Hands On”; Atomic Absorption Spectrometry in Endocrinology and TDM, Drugs of Abuse and Toxicology; Young Scientist Networking and Pediatric Pathology Including POCT; Nanotechnology in Clinical Chemistry. For more information on the conference contact: Box A1877 Avondale, Harare, Zimbabwe; Tel: 263-4791631 ext. 2126, Fax: 263 4705155; Email: [email protected] LabMedica International February-March/2015 26 News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information NEWS Mexico’s 8th International Conference on Quality Held in October 2014 by Dr. Rosa Isabel SIERRA-AMOR, Corresponding Member IFCC News, IFCC EB Member p to today, Quality topics are of a great interest for the laboratory professionals, being accreditation, risk management and cost analysis at the top of the list in Latin America. This year, BIO-RAD Mexico and Latin America organized the eighth International Conference on Quality, with the auspices of the Mexican Association of Clinical Laboratory Sciences, Full Member society IFCC, and IFCC C-CC. The scientific program included speakers from Mexico and the United States. The first topic on “Laboratory accreditation and quality con- U trol,” by Lic. Oliver Iruegas and QCB Isabel Alvarez, from the Laboratorio Dr. Moreira, from Monterrey, NL, Mexico, an accredited laboratory based on ISO 15189 by UKAS since 2005. The second talk was on “How does poor quality affects total cost,” by Ann Daley, MS, a laboratory consultant from Chi Solutions in the US. In addition, John Youth-Pacheco, PhD, a fellow researcher from Bio Rad US, spoke about “Risk management: the new way to determine the frequency of control material.” This important conference was organized in collaboration with Bio Scientists Invited to Apply for 2015 Wiener Lab Award iener Lab supports scientific work that has a direct and positive on laboratory science research carried out at the global level. With the Congress of the Latin American Confederation of Clinical Biochemistry, held every two years in different countries of Latin America under the auspices of scientific societies the group is collaborating directly by providing the Wiener Lab prize. The President of the Organizing Committee, Dr. Maria del Carmen Pasquel had the opportunity to talk directly with Dr. Rafael Rey marketing manager, Wiener Lab during his visit to the city of Rosario in November. In this workshop it was possible to enter into such agreements, guidelines and support to be given by the Company Wiener Lab to the Ecuadorian Society of Clinical Biochemistry organizer COLABIOCLI XXII Congress 2015 to be held from September 24–26, 2015, in Quito, Ecuador. The award consists of a bonus incentive of USD 2,000 plus all expenses paid (lodging, transportation) for the scientific winner, who will receive the award at the Opening Ceremony of the event. The guidelines to follow are on the conference website www.sebiocli-ec.org. The participant sends an anonymous description of their research to the President of the Organizing Committee. W IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846 E-mail: [email protected] • Web: www.ifcc.org Office Hours: 9.00-13.00 and 14.00-18.00 Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi 27 LabMedica International February-March/2015 Photo: John Youth-Pacheco, PhD from the US Rad local distributors from all around México and Latin America, giving the opportunity that 1,491 professionals saw the eighth International Conference on Quality; venues were from Argentina, Chile, Ecuador, Dominican Republic, México, Uruguay and Venezuela. Chile had 32 remote sites and Mexico another 17 allowing that more professionals were able to listen to the experts. In Mexico City, attendees had the opportunity to shake hands with the speakers and discussed in person the topics, in addition, speakers were responding in real time the questions that audience were asking by messenger or “whatsapp.” For Mexico and Latin America, this conference sponsored in full by BIO-RAD has contributed extensively to improve the knowledge of quality issues to laboratory medicine professionals. We hope to have several more conferences of this in the years to come. An experienced panel composed of professionals from different countries review the scientific papers and one month before starting the conference the winner will be announced. The winner will attend the Congress to receive their prize and the work will be published in different media and magazines in the scientific world. We encourage all professionals to submit their scientific research in Laboratory Sciences, for consideration at the XXII Congress COLABIOCLI 2015 in Quito, Ecuador, by sending an email to the address below. Information and registration: [email protected], Detailed information and registration at: www.sebiocli-ec.org Photo: (From left to right) Dr. María del Carmen Pasquel - XXII Congress Organizing Committee President COLABIOCLI 2015; Dr. Rafael Rey Wiener Lab Manager Marketing Group; Dr. Lida Morisoli - President Foundation Wiener Lab Scientific Committee LINKXPRESS COM LMI-03-15 127 EFLM CORNER European Federation of Clinical Chemistry and Laboratory Medicine Edited by Dr. Bernard Gouget EuroMedLab PARIS 2015: A Living Lab at the Service of Innovation! by Dr. Bernard Gouget Chair, COC and Co-President EuroMedlab Paris 2015; SFBC-EFLM Representative; Secretary General, International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML) t is a pleasure to welcome you, next June 21–25, at the EuroMedLab Paris 2015. This, the 21st IFCC regional congress in Europe, is one of the largest bi-annual lab med conferences worldwide and one of the major European trade shows bringing together the largest number of IVD companies. It was established in 1974 (Munich, Germany) as one of the first conferences for specialists in Lab Medicine facilitating exchanges between countries in Europe and at international level. The mission is to foster international understanding, to encourage cooperation within the lab med community, to pro- I mote high quality science, and to bring together young and senior specialists in Lab Medicine, researchers, physicians, leading government officials, and representatives from industry as well as from non-governmental organizations and healthcare systems worldwide to address the most pressing issues facing Lab Medicine and healthcare systems over the next decade and beyond. The motto of the conference “R-evolution in Lab Medicine” emphasizes the importance of Lab Medicine in patient care and wellness in the 21st century. The scientific program demonstrates the invalu- able role that the Lab Medicine plays in health care. Emphasis is put on a high quality scientific and educational program. This is realized in scientific sessions, educational workshops focusing on both open discussions and hands-on topics and lectures series that cover the most up-to-date topics in the expanding field of laboratory medicine and bringing together an array of leading international speakers and opinion leaders. The conferences, coordinated by Prof. Philippe Gillery, will cover various areas of laboratory medicine: the evolution of daily practice (relations with patients, laboratory organization, preanalytical errors), perspectives in organ pathologies (cardiovascular diseases, renal diseases, hematology), new technologies (proteomics, metabolomics, pharmacogenomics), new medical strategies (personalized medicine, rare diseases, addictions, autoimmune diseases) and research fields (microbiome, extracellular vesicles). It is a tremendous privilege for the SFBC to organize the 21st IFCC-EFLM edition in the capital of France. Paris is constantly reinventing itself in its position as a global megalopolis and leader in innovation. It was recently rated world’s best city for students for the third consecutive year by QS rankings. Also, we would like to give the opportunity to the young scientists to present their research to the scientific community and an interested audience as well as to join the exciting party organized by Dr. Guilaine Boursier, French YS coordinator! A number of bursary programs have been planned to support their presence (see www.paris2015.org). Paris is a magnificent city revered the world over for its heritage and savoir vivre. Paris also excels in innovation and intellectual capital and attractiveness to international investors, while remaining an engine for luxury, fashion, and tourism. EuroMedLab Paris 2015 offers a new perspective on the capital and its monuments. Behind the scenes of the Opera Garnier, Montmartre, the Louvre, or the Musee d’Orsay, there is an exceptional new musical jewel box “The Philharmonie de Paris,” which opened early this year designed by renowned architect Jean Nouvel. The futuristic concert hall is revolutionizing the codes of both architecture and music. Spectacular balconies, acoustics to rival the greatest international auditoriums, inspired programming—the institution is open to all audiences and all music, from baroque to jazz and pop. With the reopening of the Musee Picasso and the Fondation Louis Vuitton designed by Frank Gehry, located next to the Palais des congres in the bois de Boulogne, the famous park on the west side of Paris, Paris has enjoyed a momentous year in the arts. Alongside Paris’s assured reputation in the fine arts, one of the city’s greatest assets is the excellence of the Paris Opera Ballet. It is considered today to be one of the world’s finest companies. Its repertoire is very extensive, ranging from the major romantic and classical ballets to creations by contemporary choreographers. The prestige of Paris involves placing innovation and appeal front and center. Paris is reinventing itself as a major leader in supporting the talents. EuroMedLab Paris 2015 will be the fireworks of Lab Medicine. Don’t miss the plenary lecture on “Innate immunity: from insects to humans” by the Nobel Prize laureate, Prof. Jules Hoffmann (France). At this landmark conference we look forward to sharing our thoughts in the hope of promoting rewarding discussions. With a large audience and participation of specialists in laboratory medicine at EuroMedLab Paris 2015, the city of lights will shine even more brightly! LabMedica International February-March/2015 28 European Federation of Clinical Chemistry and Laboratory Medicine EFLM CORNER 12th Greek National Congress Held in Athens on November 7-8, 2014 he 12th Greek Congress of Clinical Chemistry was held at the Army Museum in Athens (Greece), November 7-8, 2014. The meeting was organized by the Greek Society of Clinical Chemistry-Clinical Biochemistry (GSCC-CB) under the auspices of IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) and EFLM (European Federation of Clinical Chemistry and Laboratory Medicine). The total number of participants was 300 (170 delegates, 30 residents/technicians and 100 students). The scientific program included 4 plenary lectures, 7 roundtable discussions, 16 oral presentations, and 30 poster presentations. The Congress was honored by the participation of IFCC president-elect Prof. Maurizio Ferrari, EFLM president Prof. Mauro Panteghini, IFCC vice president Dr. Howard Morris and IFCC treasurer Dr. Bernard Gouget. Prof. Howard Morris presented the opening lecture entitled “Vitamin D and pathophysiology of bone.” Other plenary lectures focused to the activities and achievements of Prof. Seferiadis (by Assoc. Professor E. Bairaktari), the automation in the modern clinical laboratory environment (by Dr. I. Vamvoukakis, sponsored by Leriva) and the new developments in cardiology – High sensitivity troponin (by Dr. L. Lennartz and sponsored by Abbott). The Roundtable discussions focused on: Emerging new and known infections (by Dr. P. Ioannidis, Dr. S. Karabella, Dr. V. Zevgolis, and Dr. S. Tsiodras); Molecular diagnostics (by Dr. A. Apessou, Dr. F. Tsoplou, Prof. G. Nasioulas and Prof. E. Lianidou); Bone turnover markers and their biochemical and clinical utility (by Dr. C. Makris, Prof. H. Morris and Dr. S. Tournis); S-100 as biomarker (by Dr. C. Psachoulia, Dr. S Korfias and Dr. A. Papadimitriou); Point-of-care testing (by Dr. K. Dima, Dr. S. Murray and Prof. V. Spiropoulos); Current issues related to the profession of clinical chemist (by Prof. C. Croupis, Dr. C. Mitropoulos and Prof. D. Rizos), and during the T Photo: IFCC vice president Prof. Howard Morris, EFLM president Prof. Mauro Panteghini, IFCC president-elect Prof. Maurizio Ferrari, Congress Scientific Committee chairman Prof. C. Croupis, GSCC-CB president Dr K. Psarra, IFCC treasurer Dr. Bernard Gouget, and EuroMedLab 2017 president Dr. Alexander Haliassos. closing ceremony the round table; Future challenges for laboratory medicine (by IFCC president-elect Prof. Maurizio Ferrari, EFLM president Prof. Mauro Panteghini, and IFCC treasurer Dr. Bernard Gouget). Oral and poster presentations dealt with various subjects within the field of Clinical chemistry/biochemistry and the laboratory medicine in general. Dr. Otto Panagiotakis, former general secretary of the GSCC-CB, in piano, and his daughter Ms. Manto Panagiotaki, vocals, gave an excellent performance during opening ceremony with songs from Greece and other countries. During the subsequent welcome reception delegates had the opportunity to get together in a relaxing and friendly atmosphere. All members of the organizing and scientific committees had significant contributions to the success of the congress. Special note should, however, be made for Congress president Mrs. E. Botoula, GSCC-CB president Dr. K. Psarra, the Congress Scientific Committee chairman Prof. C. Croupis, and EuroMedLab 2017 president Dr. Alexander Haliassos. The day prior to the beginning of the congress, the twentieth anniversary for the establishment of postgraduate studies in Clinical Chemistry at the National and Kapodistri- an University of Athens was celebrated by faculty members from the chemistry, biology, and medical departments of the university, as well as from the Technological Institute of Athens (TEI). The event was organized by the current coordinator of the Clinical Chemistry program at the University of Athens, Prof. E. Lianidou. During all the sessions, constructive exchange of views and discussion took place between the presenting the experts and the audience. At the end of the congress it was decided that the coming 13th Greek Congress of Clinical Chemistry will be organized next fall at Heraklion-Crete. Hungarian and Swiss Societies Elect New Leadership The Hungarian Society of Laboratory Medicine (HSLM) announced its new leadership for the term of 2015-2017 as follows: President: Eva Ajzner MD, PhD; Secretary: Béla Nagy Jr. MD, PhD; Treasurer: Ferenc Liszt PhD; Dr. Béla Nagy will act also as EFLM National Representative. The Swiss Society of Clinical Chemistry has a new president since the beginning of this year. He is Prof. Dr. Martin Hersberger, who is also the Swiss Society of Clinical Chemistry national representative at the EFLM. 29 LabMedica International February-March/2015 LINKXPRESS COM LMI-03-15 129 EFLM CORNER European Federation of Clinical Chemistry and Laboratory Medicine 57th Conference of the Hungarian Society of Laboratory Medicine (HSLM): A Report bout 550 laboratory professionals and representatives of companies marketing in vitro diagnostic products convened in the Eastern Hungarian town of Nyíregyháza, on August 28-30, 2014, on the occasion of the 57th National Congress of the Hungarian Society of Laboratory Medicine (HSLM57). The congress was organized under auspices of organizations European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and European Union of Medical Specialists (UEMS). Prof. Tomas Zima, member of EFLM Executive Board represented personally EFLM at the Congress. From the Scientific Program delegates could get an insight into specific interest areas of laboratory medicine as well as look into the future of our profession. The main topics of the conference included inflammation and immunology; vascular and thrombotic diseases; therapeutic drug monitoring and toxicology; clinical microbiology; and the role of laboratory medicine in clinical research. In addition, two sessions have been devoted to those scientific works that focused on the interpretation of laboratory findings to clinicians and patients, emphasizing that A the patients themselves and clinical outcome should be in the center of laboratory work. Plenary lectures kept by the recently awarded honorary member of the society and by Jendrassik–awardees are usual highlights of HSLM conferences. These awards recognize the awardee’s outstanding educational, research, or organizational activities in the field of laboratory medicine. This year Prof. Maurizio Ferrari, president elect of IFCC received the Honorary Membership of HSLM. He gave an overview on the future of molecular biology in the diagnostic laboratories in his lecture. The International Jendrassik Award – named after Lóránd Jendrassik, the scientist who described the method for bilirubin detection – honored Prof. Thomas Szekeres (Director of the Clinical Institute for Laboratory Medicine, Medical University of Vienna), who presented the effects of natural and synthetic polyhydroxyphenolic compounds on inflammation and tumor cells in his lecture. The next speakers were the Hungarian Jendrassik–award winners. Prof. Janos Kappelmayer (Past President of HSLM, director of the Depart- Photo: Organizing and Science Committees of HSLM57 ment of Laboratory Medicine in University of Debrecen) presented in his lecture how results of basic and applied research can be transformed to daily diagnostic work. Katalin Hetyesy (Associate professor of University Pecs, head of the Central Laboratory in the Teaching Hospital of Gyor) highlighted the contribution of laboratory staff to the improvement of preanalytical phase with a special emphasis on the role of emergency departments. The future of laboratory medicine was in the focus of this conference from many perspectives. Lectures of the training and an education program entitled “The laboratory of the future – The laboratory’s future” demonstrated the state of the art and future opportunities of the fastest evolving areas of laboratory medicine in disease management. Speakers also put a special emphasis on the fact that all the exciting opportunities of technological inventions of this profession can be utilized for patients’ sake if laboratory professionals will be sufficiently experienced in how apply high tech feasibilities and how to interpret the obtained results’ clinical meaning in specific disorders. The engagement of knowledgeable, creative, devoted and motivated young professionals to laboratory medicine principally determines the future of the laboratory medicine. A specific plenary session (Youth Forum – “You have the X FACTOR”) has been dedicated to novel research achievements of young laboratory scientists who competed for the award of “The best young speaker of HSLM57.” The prize providing opportunity to present the winner’s study on the forthcoming EuroMedlab conference stimulated 18 young colleagues to participate in the competition. A block about education in laborato- ry medicine from national and European perspectives is a traditional session of HSLM conferences. This year the presentation on undergraduate and postgraduate education in laboratory medicine in Europe kept by Prof. Tomas Zima (Rector of Charles University, Prague) induced a particularly vivid discussion on potential future directions of education of our profession. On HSLM57 each author of posters had an opportunity to summarize their work in a very short oral presentation using two slides during e-poster sessions. E-poster sessions were novel elements of this congress and received general appreciation of the attendees. This way of poster presentation resulted in better poster recognition and induced real discussions. The Congress site, the wonderful park of the College Campus provided an ideal environment for memorable social and sport activities including the outdoor get-together party and a morning campus exercise to ensure a dynamic start for the scientific sessions. Based on the feedbacks of the attendees, both scientific and social events of this conference will make nice memories. The conference provided good opportunity to meet colleagues, induced good professional discussions, which has probably initiated new collaborations, stimulated new ideas in participants and, finally, improved the everyday work of the laboratory professionals. However, most importantly, our feeling is that this congress of HSLM is created an atmosphere that inspired and attracted young talented professionals who will engage themselves with laboratory medicine in the future and will contribute to the establishment of scientifically astonishing environment in general laboratories. LabMedica International February-March/2015 30 LINKXPRESS .COM LINKXPRESS .COM LMI-03-15 280 LINKXPRESS COM LMI-03-15 131 LMI-03-15 281 EUROPEAN FEDERATION OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE 2014 ANNUAL REPORT GENERAL ASSEMBLY EFLM held its Seventh General Assembly (GA) during the 3rd EFLM-UEMS Joint Congress in Liverpool (UK), on Tuesday, 7 October, 2014. During the GA EFLM President, Prof. Mauro Panteghini (MP) has provided an overview of the recent EFLM activities pointing to some important facts about EFLM: EFLM is an organization with 40 NS members, it represents almost 22,000 laboratory specialists in Europe and its key values are Transparency, Profession, Education, and Quality. EFLM Strategic plan (SP) for 2014–2015 was presented. SP has 33 actions related to several different chapters, highlighting main strategic goals and important aspects, such as the assessment of the outcome of activities of the EFLM Committees (C) and Working Groups (WG). C chairs are working closely with the respective WGs in their C to achieve maximum contribution to various aims of the SP. During the GA, National representatives had the opportunity to discuss with the IFCC President (Graham Beastall) the “Shaping the future of laboratory medicine” proposal as well as the results of the IFCC ballot on Regional representation in the IFCC EB and how will this affect the future of IFCC. EFLM Treasurer Huib Storm (HS), has reported about the recent EFLM census, according to which there are 22,000 lab professionals within Europe. The financial report and balance were approved. C-ET chair has informed the GA participants that Warsaw (Poland) has been selected as the host venue for the 4th EFLM-UEMS Joint Congress in 2016. The next GA will be held in conjunction with the EuroMedLab congress in Paris on June 21, 2015. EXECUTIVE BOARD Through the EFLM Program entitle EFLM Presence at NS meetings, during 2014, EFLM Executive Board members have participated in the following National society meetings: 1) Mauro Panteghini, 12th National Congress of Clinical Chemistry, GREEK SOCIETY OF CLINICAL CHEMISTRY-CLINICAL BIOCHEMISTRY, November 7-8, 2014, Greece; 2) Tomas Zima, 57th National Conference of Hungarian Society of Laboratory Medicine, August 28-30, 2014, Hungary; 3) Mauro Panteghini, National Conference of Clinical Laboratory, Bulgarian Society of Clinical Laboratory, 11-13 September 2014, Bulgaria; 4) Tomas Zima, XII Baltic Congress in Laboratory Medicine, September 18-20, 2014, Latvia. EFLM EB feel this is an excellent opportunity to strengthen collaboration between EFLM and its member societies. The program will be continued in 2015. EFLM EB has launched a working group on Harmonization whose aim is to act as a collector of the harmonization initiatives arising from other EFLM WGs and from National Member Societies active in the field and to promote dissemination and application of particular harmonization activities. Through this WG, EFLM will promote the use of harmonized nomenclature for analytes, common reference intervals and the use of amount of substance units in the European countries, wherever and whenever this approach is feasible. Becton Dickinson has agreed to sponsor the EFLM Walter Guder Preanalytical Award. A contract has been signed to cover 3 subsequent awards (2014, 2016, and 2018). The award is aimed for scientists under 40 years of age who have made a significant contribution to the advancement of the preanalytical phase. The 1st award has been presented during the Opening ceremony of the 3rd EFLM-UEMS Joint Congress in Liverpool, October 2014. EFLM is determined to further strengthen its collaboration with commercial companies and has therefore recently released its Policy for commercial partners. EFLM Publication policy document has been produced to ensure standardized classification and management of EFLM publications as well as uniform way of acknowledging EFLM contribution. The list of EFLM publications is available on the EFLM website at the following link: www.efcclm.eu/index.php/ eflm-publications.html EFLM has held its 1st Strategic Conference in November 2014. EFLM EB has decided to create a Task Force on Performance Goals in Laboratory Medicine (TF-PG) to coordinate the activities of the groups established as the 1st Strategic Conference outcome. EFLM is willing to take the lead in this topic as the main driver focusing its activities in the next two years on the a) Performance criteria models for specific laboratory tests, b) Harmonization of allowable limits in EQAS, c) Total error, d) Performance criteria for pre-and postanalytical (extra-analytical) phases, and e) Biological variation database. Since July 2014, EFLM has 1 full-time employee (Silvia Cattaneo) engaged to exclusively handle EFLM matters in the IFCC/EFLM Office in Milan. COMMITTEE REPORTS Committee – Communications (C-C) C-C activity has undergone reorganization with a new Chair appointed in July 2014. The C-C activities are focused to increase the EFLM visibility and to improve the efficiency of the communication channels (both for internal and external communications). Among these activities, a major effort was dedicated to the renovation and continuous update of the EFLM Publication list, and to the creation of a Twitter account through which important news and information can be easily distributed. To improve the communication towards its Member Societies, regular notes were sent to the Presidents and National Representatives to involve them actively in the EFLM projects. To establish contacts with the single members of the National Societies, a mass mailing list was created as a tool to disseminate information of interest in a rapid mode. Particular attention was dedicated to the liaison with IFCC, contributing regularly to the IFCC e-Newsletter with reports about the main EFLM activities. The Task and Finish Group on History is active and currently collecting information with the aim to create communication tools such as books and web section on the history of EFLM. Committee – Education and Training (C-ET) C-ET has produced Guidelines for EFLM-UEMS joint congress, including the bid evaluation form, EFLM Meeting guidelines, and a standardized procedure for evaluation of the EFLM bursaries. C¬ET has prepared the EFLM Speakers Bureau. C-ET is promoting active participation of young scientists in EFLM events through a number of EFLM bursaries (10 for EuroMedLab Congress, 5 for EFLM-UEMS Congress, 8 for EFLM Continuing Postgraduate Course, 3 for EFLM-BD Preanalytical Conference). WG-Distance education (WG-DE) has been reestablished and has produced two e-seminars in 2014: “How can biological variation data for high sensitive troponins be related to current recommendations for diagnosing acute myocardial infarction” (KM Aakre) and “Bias in clinical chemistry” (E Theodorsson). C-ET has been involved in the organization of several meetings (14th EFLM Course in Dubrovnik; 10th Symposium for Balkan region; 3rd EFLM-UEMS joint congress; 1st EFLM Strategic Conference). Educational materials (PPT presentations, abstracts, e-seminars) arising from these EFLM events have been made available on the EFLM website. Committee – Profession (C-P) Working Group on Common Training Frameworks and Syllabus (WG-CTF) has progressed well with compiling version 5 of the EC4 syllabus for education/training in laboratory medicine, further drawing of parallels with UEMS’ Blue Book will be welcomed in 2015. Working Group on the Recognition of Professional Qualifications (WG-RPQ) continues to liaise via CEPLIS with the EU Commission in seeking guidance on the content and presentation of a Common Training Framework (CTF) for science and pharmacy trained specialists in labora- tory medicine. A document proposing the establishment of a CTF including its drivers, an audit of laboratory medicine practice in the EU Community, the definition of equivalence of standards, the context of specialists’ contributions has been prepared with view to refinement during 2015 before submission to the EU Commission with support of 10 EU member states Committee – Quality and Regulations (C-QR) Two working groups within this Committee interrelate in many aspects. The WG Accreditation and ISO/CEN Standards (WG-A/ISO) focuses on influencing activities in ISO TC212 and CEN TC140. This relates to standards on quality management, risk management, POCT, measurement uncertainty, pre-examination aspects and others. Furthermore, it works on composing European Guidelines relating to these fields. Instances are: use of flexible scope by accreditation bodies, retention time, and implementation of reference values. It participates in the Health Care Committee of EA (European cooperation on Accreditation). The WG IVD tries to influence the new draft Regulation on IVD. It focuses on in house testing, information supplied to users, and traceability aspects. EDMA has representatives in this WG. Committee – Science (C-S) The eight working groups (biological variation, cardiac markers, guidelines, harmonization of the total testing process, patient focused laboratory medicine, personalized laboratory medicine, postanalytical phase, test evaluation) and two task and finish groups (laboratory testing for dyslipidemia and critical results) constitute the backbone and substance of the Science Committee. All groups have been active in pursuing their terms of reference: performing studies, publishing original research reports, reviews, and position papers. Members of the groups have also lectured at several international conferences. Cooperative projects have been established, which also include industry partners. Projects are ongoing with the intention of applying for research grants in international competition. EC4 FOUNDATION BOARD Together with the EFLM Profession Committee the Board met in Istanbul (June 2014, IFCC WorldLab) and Liverpool (October 2014, EuroLabFocus2014). Progress towards attracting 10 EU member states as signatories to a CTF under EU Directive 2013/55/EU has been slow. To date Slovenia has obtained national society and government confirmation that EC4’s Equivalence of Standards (an integral part of a CTF) is met. While Croatia, Slovakia, France and UK’s national societies are optimistic that government support can be elicited, more intense initiatives at government liaison with the support of the EC4 Foundation Board and EFLM EB are required if the end 2015 deadline is to be met. At its Liverpool meeting the Board approved the transfer of 15% of EC4 registration fees to EFLM to acknowledge the secretarial and administrative support of the EFLM office. The process of enhancing the functionality and ease-of-use of the registrants database, which began late in 2013, is scheduled for completion late in 2014. The number of registrants rose from 3,104 to 3,112. Two bursaries of EUR 1200 each were awarded for participation in EuroLabFocus 2014. MEETINGS EFLM has organized 4 meetings during 2014: 1) 10th EFLM Symposium for Balkan Region, Belgrade, Serbia, September 11–12, 2014; 2) 3rd EFLM-UEMS (EuroLabFocus) Joint Congress in Liverpool, October 7-10, 2014; 3) 14th EFLM Continuing Postgraduate Course in Clinical Chemistry and Laboratory Medicine in Dubrovnik, October 25-26, 2014; 4) 1st EFLM Strategic Conference, November 24-25, 2014, Milan, Italy. Mauro Panteghini EFLM President Special Supplement to Lab Medica International • 32 INDUSTRY NEWS Global Tissue and Cell Diagnostics Market Estimated at Over USD 7.4 Billion riven by new technologies and the need to discover biomarkers, the tissue and cell-based diagnostic market grew to an estimated USD 7.4 billion in revenues in 2013 for in vitro diagnostic (IVD) and other reagents used by clinical laboratories, according to a new report from Kalorama Information (New York, NY, USA; www.kaloramainformation. com). The field is being increasingly automated and many new technologies are now being applied, including in mass spectrometry, DNA sequencing, and circulating tumor cells (CTC). Kalorama's report, “The World Market for Tissue Diagnostics and Cell-Based Diagnostics,” covers testing in histology and cytology, in situ hybridization (ISH), HPV tests, flow cytometry, digital pathology and image cytometry, hematology cell assays, immunohistochemistry, CTC, and others. "Growth in the tissue and cell diagnostics market is being driven by research to better understand the biological mechanisms and processes of cancer," said Bruce Carlson, publisher of Kalorama information, "Biopsy samples are the most common and effective in this area." Tissue and cell-based testing D technologies currently being used in clinical laboratories, plus emerging technologies, are being studied by life science researchers in addition to their studies to better understand the roles of proteins and other molecules. Cell-based assays are also central in drug discovery and development (basic research, preclinical toxicology, and other). Growth is also driven by development of new targeted therapies based on research outcomes, according to Kalorama’s report. In cancer, the Pharmaceutical Research and Manufacturers of America (PhRMA) estimated that nearly 800 new medicines and vaccines are in clinical testing for cancer. While these new therapies represent a wide range of different approaches, they include new targeted therapies. In March 2014, IMS Health reported that 22 new oncology therapies were launched in the previous two years. The American Cancer Society had predicted 1,665,540 newly diagnosed cancer cases for 2014. The Kalorama report includes markettrends and breakouts of important segments, as well as profiling scores of companies and providing geographic breakdowns of this market. Transasia Bio-Medicals Receives Global Growth Company Award eading in vitro diagnostics (IVD) company Transasia Bio-Medicals Ltd. (Mumbai, India; www.transasia.co.in) has been selected as “Global Growth Company-2014” by the World Economic Forum (WEF), comprising top global enterprises. After a thorough evaluation process, Transasia Bio-Medicals was selected as one of the most dynamic and high-growth companies, and considered a trailblazer, shaper, and innovator committed to improving the state of the world. This award also recognizes the strength of Transasia’s leadership ability. The pool of candidates for 2014 was exceptionally strong and diverse, making the process all the more difficult and challenging. Transasia was selected in part on the basis of being one of the fast-growing companies with potential for global economic leadership. The nominated Global Growth Companies (GGCs) represent a broad cross-section of industry sectors but share a track record of exceeding industry standards in revenue growth, promotion of innovative business practices, and demonstration of leadership in corporate citizenship. Transasia Bio-Medicals being commended as India’s top manufacturer L 33 LabMedica International February-March/2015 and exporter of diagnostic products to over 100 countries has been happily reckoned in this group. The award was presented on November 5, 2014, at the India Economic Summit held in New Delhi, organized by WEF along with the Confederation of Indian Industry (CII). The summit facilitated the meeting of the WEF’s global multistakeholder community with the new government, to together define and help shape the country’s next phase of transformation. It enabled high-level leaders from the government, civil society, and the business sector to participate in issuebased interaction and explore how to collectively shape policies for inclusive growth. India’s Finance and Defence Minister, Mr. Arun Jaitley, inaugurated the summit. Transasia Bio-Medicals is synonymous with quality and precision. It strives to deliver holistic healthcare solutions, thus providing its patrons with technological advances backed by expertise and experience. The company’s global footprint and mission are not only being recognized in India but also globally, and it takes pride in this acknowledgement by the prestigious World Economic Forum. INTERNATIONAL CALENDAR For a free listing of your event, or a paid advertisement in this section, contact: International Calendar • LabMedica P.O.Box 802214, Miami FL 33280-2214, USA Fax: 1-954-893-0038 • E-mail: [email protected] Yellow-highlighted listings are available at US$ 300 for a one-year period. Please mail check with your event’s details to above address. APRIL 2015 SEACARE 2015. Apr 6-8; Kuala Lumpur, Malaysia; Web: https://abcex.com/default.aspx World Vaccine Congress 2015. Apr 7-9; Washington, DC, USA; Web: www.terrapinn.com Molecular Diagnostics Europe. Apr 13-16; Portugal, Lisbon; Web: www.moleculardxeurope.com 6th congress of Syndicat des Biologistes du Liban. Apr 16-18; Beirut, Lebanon; Web: www.SdbLiban.org KOREA LAB 2015. Apr 21-24; Kintex, Korea; Web: www.korealab.org ECCMID 2015 – 25th Eur. Cong. of Clin. Microbiology & Infectious Diseases. Apr 25-28; Copenhagen, Denmark; Web: www.congrex.ch 4th Congress of the African Federation of Clinical Chemistry (AFCC). Apr 28-30; Victoria Falls, Zimbabwe; Web: www.afccafrica.org MAY 2015 17th European Congress of Endocrinology. May 3-7; Dublin, Ireland; Web: www.ece2015. org Biomarkers & Diagnostics World Congress 2015. May 5-7; Philadelphia, PA, USA; Web: www.biomarkerworldcongress.com 8th European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry “Point of care testing”. May 5-6; Barcelona, Spain. Second World Congress on Water Channel Proteins (Aquaporins and Relatives). May 6- LAB MEDICA INTERNATIONAL Reader Service Form PLEASE COMPLETE THE FOLLOWING WRITE CLEARLY IN BLOCK LETTERS or AFFIX YOUR SUBSCRIBER LABEL APPEARING ON COVER I. TYPE OF LABORATORY Subscriber Code on Your Label (Needed for All Renewals) Name of Individual Position and Department Name of Institution Mailing Address City, Province Postal Code (a) (i) (c) (d) (f) (g) (l) (h) (t) ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ Hospital Laboratory Independent/Reference Laboratory Blood Bank Laboratory Public Health Laboratory Industrial/Biomedical Laboratory Government Authority/Health Agency Research/Educational Laboratory Distributor/Dealer/Manufacturer Other Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . . II. YOUR TITLE OR FUNCTION (1) (2) (3) (4) (5) (6) (7) ❏ ❏ ❏ ❏ ❏ ❏ ❏ Director of Laboratory(ies) Dept. Chief/Supervisor Chief Technologist Technologist Administrator/Manager Medical Practitioner Other Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Are you a Ph.D. or M.D.? ❏ YES IV. YOUR DEPARTMENT OR SPECIALTY Country (h) ❏ (b) ❏ (c) ❏ (d) ❏ (e) ❏ (p) ❏ (a) ❏ (o) ❏ (q) ❏ (r) ❏ (g) ❏ (k) ❏ (l) ❏ (m) ❏ (j) ❏ (t) ❏ General Lab Diagnostics Clinical Chemistry/Biochemistry Microbiology Hematology Blood Bank Immunology Anat. Pathology Serology Histology Cytology Toxicology Virology Oncology Endocrinology Administration/Purchasing Other VI. CIRCLE LINKXPRESS NUMBERS OF INTEREST TO RECEIVE FREE INFORMATION 101 111 121 131 141 151 161 171 181 191 201 211 221 231 241 251 261 271 281 291 102 112 122 132 142 152 162 172 182 192 202 212 222 232 242 252 262 272 282 292 103 113 123 133 143 153 163 173 183 193 203 213 223 233 243 253 263 273 283 293 104 114 124 134 144 154 164 174 184 194 204 214 224 234 244 254 264 274 284 294 105 115 125 135 145 155 165 175 185 195 205 215 225 235 245 255 265 275 285 295 106 116 126 136 146 156 166 176 186 196 206 216 226 236 246 256 266 276 286 296 107 117 127 137 147 157 167 177 187 197 207 217 227 237 247 257 267 277 287 297 108 118 128 138 148 158 168 178 188 198 208 218 228 238 248 258 268 278 288 298 109 119 129 139 149 159 169 179 189 199 209 219 229 239 249 259 269 279 289 299 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 300 LMI-03-15 Yes, I wish to receive free copies of Lab Medica International 10; Cluj-Napoca, Romania; Web: www.ifcc.org 11th EFLM Symp. for Balkan Region. May 1415; Belgrade, Serbia; Web: www.dmbj.org.rs ISLH 2015 – International Society of Laboratory Hematology. May 19-21; Chicago, IL, USA; Web: www.islh.org Diagnostica / Hospitalar 2015. May 19-22; Sao Paulo, Brazil; Web: www.hospitalar.com 1st Congress of Romanian Association of Laboratory Medicine. May 20-23; Sighisoara, Romania 25th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE). May 25-29; Orlando, FL, USA; Web: www.aace.com Africa Laborum 2015. May 27-29; Cape Town, South Africa; Web: www.africalaborum.com JUNE 2015 Biomarkers World Europe. Jun 2-3; London, UK; Web: www.healthnetworkcommunications. com European Human Genetics Conference 2015. Jun 6-9; Glasgow, UK; Web: www.eshg.org EAACI 2015 – 31st Eur. Cong. of Allergology and Clin. Immunology. Jun 6-10; Barcelona, Spain; Web: www.eaaci2015.com European Society for Human Reproduction and Embryology Annual Meeting – ESHRE 2015. Jun 14-17; Lisbon, Portugal; Web: www. eshre2015.eu 2015 BIO International Convention. Jun 15-18; Philadelphia, Pennsylvania; Web: http://convention. bio.org Canadian Laboratory Medicine Congress. Jun 20-24; Montreal, Canada; Web: www.clmc.ca/ 2015 EuroMedLab 2015 - 21th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine / JIB 2015. Jun 21-25; Paris, France; Web: www.paris2015.org JULY 2015 AACC 2015 – 66th Annual Meeting of American Association for Clinical Chemistry. Jul 2630; Atlanta, GA, USA; Web: www.aacc.org Renew /Start your Free Subscription FREE PRODUCT Instant Online INFORMATION Product Information Every advertisement or product item in this issue contains a LinkXpress ® number as shown below: LINKXPRESS COM 1 2 3 LMI-03-15 123 Identify LinkXpress ® codes of interest as you read magazine Click on LinkXpress.com to reach reader service portal Mark code(s) of interest on LinkXpress ® inquiry matrix Or, Circle LinkXpress Numbers of Interest on Reader Service Card and Fax Card to: ++1-954-893-0038 SIGNATURE (REQUIRED) Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . . V. With how many readers do you share this copy of Lab Medica Intl ? . . . . . . . . . DATE: DAY ................. MONTH ........................ YEAR .................... The publisher reserves the right to qualify requests Tel: (..........)(..........)...................... For EXPRESS service: E-MAIL (REQUIRED): visit www.LinkXpress.com or fax this form to: .................................................... @................................................ USA: ++1-954-893-0038 LabMedica International February-March/2015 34 INTERNATIONAL CALENDAR AUGUST 2015 FIME 2015 – Florida International Medical Exhibition. Aug 5-7; Miami, FL, USA; Web: www.fimeshow.com Biochemical and Molecular Basis of Multifactorial Diseases. Aug 21-Oct 23; Moron, AR; Web: www.ifcc.org SEPTEMBER 2015 6th International Conference and Exhibition on Analytical & Biochemistry and Laboratory Medicine. Sep 1-3; Valencia, Spain; Web: http:// analytical-bioanalytical.pharmaceuticalconferences.com Biotech China 2015. Sep 3-5; Nanjing, China; Web: http://en.biotechchina-nj.com 34th International ISBT – International Society Blood Transfusion Congress. Sep 4-8; Dubai, UAE; Web: www.isbtweb.org ESP 2015 – 27th European Congress of Pathology. Sep 5-9; Sava Centar, Belgrade, Serbia; Web: www.esp-pathology.org 18th Annual Meeting of the ESCV – European Congress of Virology. Sep 9-12; Edinburgh, Scotland; Web: www.escv.org Eurotox 2015 – 51st Congress of the European Societies of Toxicology. Sep 14-16; Porto, Portugal; Web: www.eurotox2015.com MEMBS 2015 – 2nd Middle East Molecular Biology Congress and Exhibition. Sep 17-20; Istanbul, Turkey; Web: www.membs.org BSACI – British Society of Allergy & Clinical Immunology Annual Meeting. Sep 20-22; London, England; Web: www.bsaci.org 39th European Congress of Cytology. Sep 2023; Milan, Italy; Web: www.cytology2015.com 8th Congress of the Croatian Society of Medichal Biochemistry and Laboratory Medicine. Sep 22-26; Rijeka, Hungaria; Web: http:// kongresrijeka2015.hdmblm.hr Analitica Latin America 2015 International Exhibition of Laboratory Technology, Analyses, Biotechnology and Quality Control. Sep 22-24; Sao Paulo - Brazil; Web: www.analiticanet.com ExpoMedical 2015. Sep 23-25; Buenos Aires, Argentina; Web: www.expomedical.com.ar ESPT 2015 - 3rd Conference on Integration of V I S I Pharmacogenomics in Clinical Decision Suport. Sep 24-26; Budapest, Hungary; Web: www. esptcongress.eu COLABIOCLI 2015 - 22nd Cong. LatinoAmericano de Bioquímica Clinica. Sep 2426; Quito, Ecuador; Web: www.sebiocli-ec.org 41st Annual Meeting of the American Society for Histocompatibility and Immunogenetics (ASHI). Sep 28-Oct 2; Savannah, GA, USA; Web: www.ashi-hla.org OCTOBER 2015 54th Annual ESPE Meeting – European Society of Paediatric Endocrinology. Oct 1-3. Oct 13; Barcelona, Spain; Web: www.espe2015.org BIOTECHNICA 2015. Oct 6-8; Hannover, Germany; Web: www.biotechnica.de BCLF 2015 - 23rd Meeting of Balkan Clinical Laboratory Federation. Oct 7-9; Sarajevo, Bosnia; Web: http://bclf2015.org 8th Congreso Nacional Bioquímico (CUBRA). Oct 7-10; Catamarca, AR; Web: www.cubra2015. com.ar 3rd ESPT Conference “Integration of Pharmacogenomics in Clinical Decision Support”. Oct 7-10; Budapest, HU; Web: www.esptcongress.eu ASHG 2015. Oct 25-29; Orlando, FL; Web: www.aaps.org ASCP 2015 – American Society for Clinical Pathology. Oct 28-31; Long Beach, CA, USA; Web: www.ascp.org NOVEMBER 2015 ArabMedLab 2015 - 14th Arab Congress of Clinical Biology (AFCB). Nov 1-3; Khartoum, Sudan; Web: www.ifcc.org Association for Molecular Pathology (AMP) Annual Meeting 2015. Nov 5-7; National Austin, TX, USA; Web: www.amp.org MEDICA 2015. Nov 16-19; Dusseldorf, Germany; Web: www.medica-tradefair.com Congress on Pathology and Laboratory Medicine. Nov 18-21; Cancun, Mexico; Web: www. pathologycancun2015.org 9th World Congress on Pediatric Infectious Diseases. Nov 18-21; Rio De Janeiro, Brazil; Web: http://wspid.kenes.com LabMedica International T LINKXPRESS COM R E A D E R S E R V I C E P O R T A L 2 E ASY WAYS To Continue / Start Your FREE Subscription ONLINE 1 Visit LinkXpress.com to enter your subscription data and reader inquiries. B Y FA X 2 Vol. 32 No. 1 • 2-3/2015 ® • Fill-out all required data on Reader Service Card including signature and date (incomplete or unsigned cards cannot be processed). • Circle inquiry numbers of interest to receive free information • Fax card without delay to: ++1-954-893-0038 ATTENTION: IF YOUR APPLICATION IS NOT RECEIVED AT LEAST ONCE EVERY 12 MONTHS YOUR FREE SUBSCRIPTION MAY BE AUTOMATICALLY DISCONTINUED ADVERTISING INDEX Inq.No. Advertiser Page – – 108 115 121 114 113 – 112 – 131 116 136 118 117 119 11th EFLM Balkan Symp. .33 AACC . . . . . . . . . . . . . . . .25 Adam Instruments . . . . . . .8 Advanced Instruments . . .15 Advanced Instruments . . .21 Alcor . . . . . . . . . . . . . . . . .14 Autobio Diagnostics . . . . .13 BCLF 2015 . . . . . . . . . . . .30 BIOHIT HealthCare . . . . . .12 Biotech China 2015 . . . . .34 Brand . . . . . . . . . . . . . . . .31 Caretium . . . . . . . . . . . . . .16 Cellavision . . . . . . . . . . . .36 DAS . . . . . . . . . . . . . . . . .18 DiaSource . . . . . . . . . . . . .17 DiaSys . . . . . . . . . . . . . . .19 Inq.No. Advertiser 102 107 111 – 110 – – – 122 126 129 103 109 127 105 124 ELITech Group . . . . . . . . . .2 Erba . . . . . . . . . . . . . . . . . .7 Focus Diagnostics . . . . . . .11 EuroMedLab Paris 2015 . .28 Hecht, Karl . . . . . . . . . . . .10 Hospitalar 2015 . . . . . . . .35 LabMedica.com . . . . . . . . .6 MEMBS 2015 . . . . . . . . . .33 NG Biotech . . . . . . . . . . . .23 Rayto . . . . . . . . . . . . . . . .26 SFRI . . . . . . . . . . . . . . . . .29 SNIBE . . . . . . . . . . . . . . . . .3 SNIBE . . . . . . . . . . . . . . . . .9 Statens Serum Institut . . .27 VEDA.LAB . . . . . . . . . . . . .5 Vicotex . . . . . . . . . . . . . . .24 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions. 35 LabMedica International February-March/2015 Page LINKXPRESS COM LMI-03-15 136