LabMedica - Vol. 32 No.1 • 2-3



LabMedica - Vol. 32 No.1 • 2-3
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
Molecular Test Identifies
Acute Transplant Rejection
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
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
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
Cont’d on page 8
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
Renew /Start your
Free Subscription
Access Interactive
Digital Magazine
Instant Online
Product Information:
LinkXpress codes of
1 Identify
interest as you read magazine
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
Mitochondrial Mutations
In Glaucoma Identified
Breakthrough Platform
Improves Infectious Disease
Diagnosis and Control
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.
Cont’d on page 4
Improved Assay Determines
D-Xylose in Urine and Serum
Antibody Test Predicts
Cold-Related Asthma Attacks
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
>>> M E D I A <<<
Scan with
to Access
Latest News
LMI-03-15 102
LMI-03-15 103
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; 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
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; 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
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
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 • • • •
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
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;
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
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
Send Press Releases to:
Advertising & Ad Material:
Other Contacts:
[email protected]
[email protected]
[email protected]
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
[email protected]
Gerrards Cross, UK
Tel: (44) 1753-892-791
[email protected]
Genoa, Italy
Tel: (39) 10-570-4948
[email protected]
Tokyo, Japan
Tel: (81) 3-5691-3335
Shenzen, Guangdong, China
[email protected]
Tel: (86) 755-8375-3877
[email protected]
Contact USA Office
Tel: (1) 954-893-0003
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
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
for daily laboratory medicine news click to
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; 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;
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
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; 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; 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.
LabMedica International
LMI-03-15 105
to read this issue in interactive digital magazine format click to
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; 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
Anytime, Anywhere, On the Go...
Website Editions:
English Spanish
Chinese Russian
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. 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
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
LMI-03-15 254
LMI-03-15 260
LMI-03-15 261
LMI-03-15 262
LMI-03-15 253
LMI-03-15 255
LMI-03-15 251
LMI-03-15 259
LMI-03-15 250
LMI-03-15 256
LMI-03-15 252
LMI-03-15 257
LMI-03-15 107
LMI-03-15 258
to read this issue in interactive digital magazine format click to
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; 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;; 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;
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
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; 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; Life Technologies is a
subsidiary of Thermo Fisher Scientific (Waltham,
Massachusetts, USA;
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).
LMI-03-15 108
LabMedica International
for daily laboratory medicine news click to
Human Genome Mapping Gaps
Revealed by Latest Technology
cont’d from cover
School of Medicine (Seattle, WA, USA; 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; 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).
Renew / Start your
Free Subscription
Access Interactive
Digital Magazine
Instant Online
Product Information
LabMedica International
LMI-03-15 109
to read this issue in interactive digital magazine format click to
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-
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;, 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;
ARCHITECT c Systems; the Beckman Coulter (Indianapolis, IN, USA; UniCel
DxC 600/800; the Bio-Rad (Hercules, CA, USA;
D-10/Variant II and Variant II Turbo;
the Roche (Pleasanton, CA, USA; cobas
INTEGRA/6000/c311; the Siemens
(Malvern, PA, USA; www.siemens.
com) Dimension Series; and the
Tosoh (Grove City, OH, USA; www. 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; 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
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
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
LMI-03-15 111
to read this issue in interactive digital magazine format click to
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; 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
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. 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; 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-
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
for daily laboratory medicine news click to
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; have granted
a CLIA Waiver for the fourth generation Alere Determine HIV-1/2 Ag/Ab Combo test (Alere; San
Diego, CA, USA; 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
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; 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;, 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.”
LabMedica International
LMI-03-15 113
to read this issue in interactive digital magazine format click to
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; 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-
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
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; working with colleague in the Republic of Congo collected venous
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; 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; 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; 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
for daily laboratory medicine news click to
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
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; 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
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,
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; and their colleagues at Uppsala University, (Sweden;
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; 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;
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.
LabMedica International
LMI-03-15 115
to read this issue in interactive digital magazine format click to
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; 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; 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
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
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; 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; 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
The study was published in the December 15,
2014, online edition of the Journal of Thoracic Oncology.
LabMedica International
for daily laboratory medicine news click to
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.
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; The cobas Strep A test is Conformité Européenne (CE) Marked and the US Food
and Drug Administration (FDA; Silver Spring, MD,
USA; 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; 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; 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.
LabMedica International
LMI-03-15 117
To receive prompt and free information on products, log on to or fill out reader service form located on last page
Caretium Instruments
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.
LMI-03-15 201
LMI-03-15 202
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
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. 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;, 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
for daily laboratory medicine news click to
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;, 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; 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.
Image: Brain tumors are hereditary in some cases,
and now a gene mutation has been identified as the
culprit (Photo courtesy of Shutterstock).
LabMedica International
LMI-03-15 119
To receive prompt and free information on products, log on to or fill out reader service form located on last page
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.
LMI-03-15 204
LMI-03-15 205
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; 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. When necessary, one or more
tests were also performed, morphology on
Sabouraud dextrose agar (SDA), germ tube test for
Candida species, and urease assimilation test for Cryptococcus species (Becton, Dickinson and Company; Sparks,
MD, USA; Protein was
extracted from the isolates and analyzed on MALDI-TOF Bruker MS (Bruker Biotyper, Bruker Daltonics; Bremen,
Germany; 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;
evaluated the lymphocyte morphology on archived
blood films of 97 CLL patients, and results of their
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;
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
LabMedica International
for daily laboratory medicine news click to
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
Molecular Bioscientists at the Mahidol University, Nakhonpathom, Thailand; www.mahidol. 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
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; 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; 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; or a desolvating sample system
(DSN) (Nu Instruments, Oxford, UK;
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.
LabMedica International
LMI-03-15 121
To receive prompt and free information on products, log on to or fill out reader service form located on last page
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.
LMI-03-15 207
LMI-03-15 208
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; 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 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
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; used quantitative polymerase chain reaction (qPCR) and western blotting
for micro ribonucleic acid (miRNA) profiling of
breast cancer cells and quantitative real-time PCR
for validation. Total RNAs were isolated and purified with the miRNeasy Mini Kit (Qiagen; Venlo,
The Netherlands; The miRNA
expression array hybridization was performed using
the Human miRNA Microarray Kit V3 (Agilent,
Santa Clara, CA, USA;, 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
for daily laboratory medicine news click to
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; 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. 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-
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; 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. 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
LabMedica International
Optium meter (Abbott, Maidenhead, UK; www.
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
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
To receive prompt and free information on products, log on to or fill out reader service form located on last page
Wondfo Biotech
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.
LMI-03-15 210
LMI-03-15 211
LMI-03-15 212
New Diagnostic Test
For Pancreatic Cancer
Your Source for Sterilization Accessories
Up to 37 cm
in length
Thermo-Resistant (-60 °C to 300 °C)
Fully Washable & Flexible
Suitable for central sterilization services
Heavy Silicone Cover & Transport Tablet
Exchangable Net
Exchangable Nets
100% Silicone
Size: 2400 x 1200 mm (3 mm thick)
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
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; 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;
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
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
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.
LMI-03-15 124
LabMedica International
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]
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
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
LabMedica International
Maurizio Ferrari
Graham Beastall
Past President
Sergio Bernardini
Tomris Ozben
News from the World of the International
Federation of Clinical Chemistry and Laboratory Medicine
Visit for more information
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
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.
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;
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:
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-
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-
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
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
News from the World of the International
Federation of Clinical Chemistry and Laboratory Medicine
Visit for more information
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-
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 The participant
sends an anonymous description of
their research to the President of the
Organizing Committee.
Via Carlo Farini 81, 20159 Milan, ITALY
Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846
E-mail: [email protected] • Web:
Office Hours: 9.00-13.00 and 14.00-18.00
Staff Members: Paola Bramati, Silvia Cardinale,
Silvia Colli-Lanzi
LabMedica International
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:
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
LMI-03-15 127
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-
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
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
LabMedica International
European Federation of Clinical
Chemistry and Laboratory Medicine
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.
Current issues related to the profession of clinical chemist (by Prof.
C. Croupis, Dr. C. Mitropoulos and
Prof. D. Rizos), and during the
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
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.
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.
LabMedica International
LMI-03-15 129
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
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
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
LMI-03-15 280
LMI-03-15 131
LMI-03-15 281
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.
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
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:
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 – 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
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
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
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
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.
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.
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
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.
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
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;
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
LabMedica International
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.
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:
World Vaccine Congress 2015. Apr 7-9; Washington, DC, USA; Web:
Molecular Diagnostics Europe. Apr 13-16; Portugal, Lisbon; Web:
6th congress of Syndicat des Biologistes du
Liban. Apr 16-18; Beirut, Lebanon; Web:
KOREA LAB 2015. Apr 21-24; Kintex, Korea;
ECCMID 2015 – 25th Eur. Cong. of Clin. Microbiology & Infectious Diseases. Apr 25-28;
Copenhagen, Denmark; Web:
4th Congress of the African Federation of
Clinical Chemistry (AFCC). Apr 28-30; Victoria Falls, Zimbabwe; Web:
MAY 2015
17th European Congress of Endocrinology.
May 3-7; Dublin, Ireland; Web: www.ece2015.
Biomarkers & Diagnostics World Congress
2015. May 5-7; Philadelphia, PA, USA; Web:
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-
Reader Service Form
Subscriber Code on Your Label
(Needed for All Renewals)
Name of Individual
Position and Department
Name of Institution
Mailing Address
City, Province
Postal Code
Hospital Laboratory
Independent/Reference Laboratory
Blood Bank Laboratory
Public Health Laboratory
Industrial/Biomedical Laboratory
Government Authority/Health Agency
Research/Educational Laboratory
Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . .
Director of Laboratory(ies)
Dept. Chief/Supervisor
Chief Technologist
Medical Practitioner
Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . .
III. Are you a Ph.D. or M.D.?
(h) ❏
(b) ❏
(c) ❏
(d) ❏
(e) ❏
(p) ❏
(a) ❏
(o) ❏
(q) ❏
(r) ❏
(g) ❏
(k) ❏
(l) ❏
(m) ❏
(j) ❏
(t) ❏
General Lab Diagnostics
Clinical Chemistry/Biochemistry
Blood Bank
Anat. Pathology
Yes, I wish to receive free copies
of Lab Medica International
10; Cluj-Napoca, Romania; Web:
11th EFLM Symp. for Balkan Region. May 1415; Belgrade, Serbia; Web:
ISLH 2015 – International Society of Laboratory Hematology. May 19-21; Chicago, IL,
USA; Web:
Diagnostica / Hospitalar 2015. May 19-22; Sao
Paulo, Brazil; Web:
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:
Africa Laborum 2015. May 27-29; Cape Town,
South Africa; Web:
JUNE 2015
Biomarkers World Europe. Jun 2-3; London,
UK; Web: www.healthnetworkcommunications.
European Human Genetics Conference 2015.
Jun 6-9; Glasgow, UK; Web:
EAACI 2015 – 31st Eur. Cong. of Allergology
and Clin. Immunology. Jun 6-10; Barcelona,
Spain; Web:
European Society for Human Reproduction
and Embryology Annual Meeting – ESHRE
2015. Jun 14-17; Lisbon, Portugal; Web: www.
2015 BIO International Convention. Jun 15-18;
Philadelphia, Pennsylvania; Web: http://convention.
Canadian Laboratory Medicine Congress. Jun
20-24; Montreal, Canada; Web:
EuroMedLab 2015 - 21th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine / JIB 2015. Jun 21-25; Paris,
France; Web:
JULY 2015
AACC 2015 – 66th Annual Meeting of American Association for Clinical Chemistry. Jul 2630; Atlanta, GA, USA; Web:
Renew /Start your
Free Subscription
Product Information
Every advertisement
or product item
in this issue contains
a LinkXpress ® number
as shown below:
LMI-03-15 123
Identify LinkXpress ® codes of
interest as you read magazine
Click on
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
Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . .
V. With how many readers do you share
this copy of Lab Medica Intl ? . . . . . . . . .
DAY ................. MONTH ........................ YEAR ....................
The publisher reserves the right to qualify requests
Tel: (..........)(..........)......................
For EXPRESS service:
or fax this form to:
USA: ++1-954-893-0038
LabMedica International
FIME 2015 – Florida International Medical
Exhibition. Aug 5-7; Miami, FL, USA; Web:
Biochemical and Molecular Basis of Multifactorial Diseases. Aug 21-Oct 23; Moron, AR;
6th International Conference and Exhibition on
Analytical & Biochemistry and Laboratory
Medicine. Sep 1-3; Valencia, Spain; Web: http://
Biotech China 2015. Sep 3-5; Nanjing, China;
34th International ISBT – International Society Blood Transfusion Congress. Sep 4-8; Dubai,
UAE; Web:
ESP 2015 – 27th European Congress of Pathology. Sep 5-9; Sava Centar, Belgrade, Serbia;
18th Annual Meeting of the ESCV – European
Congress of Virology. Sep 9-12; Edinburgh,
Scotland; Web:
Eurotox 2015 – 51st Congress of the European
Societies of Toxicology. Sep 14-16; Porto, Portugal; Web:
MEMBS 2015 – 2nd Middle East Molecular
Biology Congress and Exhibition. Sep 17-20;
Istanbul, Turkey; Web:
BSACI – British Society of Allergy & Clinical
Immunology Annual Meeting. Sep 20-22; London, England; Web:
39th European Congress of Cytology. Sep 2023; Milan, Italy; Web:
8th Congress of the Croatian Society of
Medichal Biochemistry and Laboratory Medicine. Sep 22-26; Rijeka, Hungaria; Web: http://
Analitica Latin America 2015 International Exhibition of Laboratory Technology, Analyses,
Biotechnology and Quality Control. Sep 22-24;
Sao Paulo - Brazil; Web:
ExpoMedical 2015. Sep 23-25; Buenos Aires,
Argentina; Web:
ESPT 2015 - 3rd Conference on Integration of
Pharmacogenomics in Clinical Decision Suport. Sep 24-26; Budapest, Hungary; Web: www.
COLABIOCLI 2015 - 22nd Cong. LatinoAmericano de Bioquímica Clinica. Sep 2426; Quito, Ecuador; Web:
41st Annual Meeting of the American Society
for Histocompatibility and Immunogenetics
(ASHI). Sep 28-Oct 2; Savannah, GA, USA;
54th Annual ESPE Meeting – European Society of Paediatric Endocrinology. Oct 1-3. Oct 13; Barcelona, Spain; Web:
BIOTECHNICA 2015. Oct 6-8; Hannover, Germany; Web:
BCLF 2015 - 23rd Meeting of Balkan Clinical
Laboratory Federation. Oct 7-9; Sarajevo,
Bosnia; Web:
8th Congreso Nacional Bioquímico (CUBRA).
Oct 7-10; Catamarca, AR; Web: www.cubra2015.
3rd ESPT Conference “Integration of Pharmacogenomics in Clinical Decision Support”. Oct
7-10; Budapest, HU; Web:
ASHG 2015. Oct 25-29; Orlando, FL; Web:
ASCP 2015 – American Society for Clinical
Pathology. Oct 28-31; Long Beach, CA, USA;
ArabMedLab 2015 - 14th Arab Congress of
Clinical Biology (AFCB). Nov 1-3; Khartoum,
Sudan; Web:
Association for Molecular Pathology (AMP)
Annual Meeting 2015. Nov 5-7; National Austin,
TX, USA; Web:
MEDICA 2015. Nov 16-19; Dusseldorf, Germany; Web:
Congress on Pathology and Laboratory Medicine. Nov 18-21; Cancun, Mexico; Web: www.
9th World Congress on Pediatric Infectious
Diseases. Nov 18-21; Rio De Janeiro, Brazil;
LabMedica International
To Continue / Start Your
FREE Subscription
Visit to enter
your subscription data and reader
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:
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
ELITech Group . . . . . . . . . .2
Erba . . . . . . . . . . . . . . . . . .7
Focus Diagnostics . . . . . . .11
EuroMedLab Paris 2015 . .28
Hecht, Karl . . . . . . . . . . . .10
Hospitalar 2015 . . . . . . . .35 . . . . . . . . .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.
LabMedica International
LMI-03-15 136