Trichomonas – Time to Know the Facts
Transcription
Trichomonas – Time to Know the Facts
10/16/2014 Conflicts of Interest Trichomonas – Time to Know the Facts Research support and/or participation in clinical trials from the following companies and sources that have to do with today’s subject: NIH, DOH RI, APHL Gen-Probe, BD, Cepheid Kimberle Chapin MD DABMM, FCAP Director of Microbiology and Infectious Diseases Molecular Diagnostics Lifespan Hospital, Brown Medical School Providence, RI 1 K Chapin MD 2014 The Rodney Dangerfield of STI’s 2 Case Trichomonas vaginalis K Chapin MD 2014 55 yo man presents to MD for routine physical exam and minimal urogenital complaints Previous exam, including prostate WNL Social history: Divorced for 3 years and currently “dating” …..alot HPI/PE: no specific complaints other than occasional urinary frequency and difficulty or pain urinating, and sometimes pain during or after ejaculation gets no respect 3 K Chapin MD 2014 Case 4 Case 45 yo woman presents to MD for GYN exam Previous exam, including PAP WNL Social history: Divorced for 3 years and currently “dating”…..alot HPI/PE: no specific complaints except occasional itching in vaginal area, GYN exam shows only some thin watery discharge Wet mount negative Urine Culture negative HIV negative Nucleic Amplification urine test (NAATs) negative for CT/GC Urine NAAT positive for TV 5 K. Chapin MD 2014 K. Chapin MD 2014 6 K. Chapin MD 2014 1 10/16/2014 Case 3A Presentation Outline Urine Culture negative HIV negative NAAT Endocervical swab negative for CT/GC Endocervical swab NAAT positive for TV Disease background in context of other STIs Pathogenesis Clinical Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Treatment Considerations for future action and Public Health 7 Genital Infections – Basic Tenants Estimates of New Cases of STIs US (2008) Satterwhite, Torrone et al, 2013 STD, 40(3) 187-193 Asymptomatic partners transmit infections Many infections with overlapping in signs and symptoms so clinical diagnosis not specific Diagnostic Testing is recommended: Appropriate RX can be focused Specific diagnosis increases therapeutic compliance Complies with state PH reporting K8Chapin MD 2014 K. Chapin MD 2014 Hep B = 19,000 HIV= 49,000 Syphilis = 55,400 HSV-2 = 776,000 HSV-1 Genital Infections By both patient and partner Gonorrhea = 820,000 Trichomoniasis = 1,090,000 Alas….current available test diagnostics lacking 1.5 million new cases per year HSV Chlamydia = 2,860,000 25-40% of patients the entity is not clear HPV = 14,100,000 (includes non-HR) 20 million new infections/year (incidence); 110 million total infections (prevalence) 9 K. Chapin MD 2014 in the US COST in US dollars $16 BILLION 10 K. Chapin MD 2014 Trichomonas vaginalis – Healthcare Associated Costs Syphilis: 14,000 TV is one of the top 5 ignored infections in the world (CDC 2014) Direct medical costs for TV infection alone: HIV: 50,000 Sequelae related to increased risk for HIV transmission: Gonorrhea: 700,000 Misdiagnosis and inappropriate RX of common entity:$$? Hepatitis B Virus: 43,000 Chlamydia: 1.4 Million Herpes Simplex Virus: 1.5 Million Human Papilloma Virus: 6 Million estimated at $34.2 million $167 million Vaginosis,vaginitis that continues to come back over and over No routine testing for TV unless symptomatic or high risk Partners NOT empirically tested or treated NOT a reportable disease Trichomonas: 7.2 million 11 K. Chapin MD 2014 12 K Chapin MD 2012 2 10/16/2014 Life-cycle of T. vaginalis is simple Presentation Outline Disease background in context of other STIs Pathogenesis Clinical Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Treatment Considerations for future action and Public Health K13 Chapin MD 2014 14 Pathogenesis of Trichomonas – Much to Learn • Attaches to epithelial cells Subsequent intense local immune response mainly with: • Neutrophils but also Lymphocyte recruitment including CD4+ cells • • Recruitment of inflammation-related factors: • • • Cytokines and chronic stimulation that has implications for pathology and cancer Phagocytosis Vector for spread of other organisms • Carrying pathogens attached to their surface into fallopian tubes, into prostate 15 K Chapin MD 2014 Presentation Outline Disease background Pathogenesis Clinical Features and Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Treatment Considerations for future action TV prefers an anaerobic environment and pH 6.0 Vaginal bacteria and host cells which alters normal flora • • Micro-ulcerations • Can deal with 4.5 – which may be why some infections with low organism burden Healthy vagina pH = 3.8-4.5 Accomplish fermentative carbohydrate metabolism and Produces H2 gas Hormone levels Coexisting vaginal flora Strain of TV Relative concentration of organism present TV phagocytosing vaginal bacteria creates a more alkaline environment (> 4.5 pH) TVcontains structures called Hydrogenosomes (no mitochondria) Inflammatory response to the parasite may determine severity of symptoms Factors that influence the host response: 16 K Chapin MD 2014 Clinical Features Incubation period 4-28 days Symptoms and signs in women Vaginal discharge, pruritus, and irritation, dysuria Vaginal discharge, odor, edema or erythema, pH > 4.5 Frothy in only 10% Colpitis macularis (strawberry cervix) specific for TV but only on colposcopy and rarely on routine examination Extent of inflammatory response my determine severity of SXS 50% of women are asymptomatic Most men are asymptomatic (> 75%) 17Chapin MD K 2014 K Chapin MD 2014 Pathology of Trichomonas vaginalis Releases proteins which by direct contact result in: • •Single-celled protozoan •Divides by binary fission •Only troph stage identified •Only infects humans •Infection transmitted sexually •Natural infection exists on the mucosa of the genital lumen •10 -105 protozoa/ml 18 Recent studies suggest TV is more common cause of NGU than previously thought TV should be considered in male that fails therapy of NGU K Chapin MD 2014 3 10/16/2014 Associated risks and sequelae associated with trichomoniasis Associated risks and sequelae associated with trichomoniasis Prenatal Women Premature rupture of membranes Pre-term Delivery Men NG/NC Urethritis Epididymitis Prostatitis/ Proctitis Infertility and Decreased sperm motility/viability Invasive Prostate Cancer Vaginitis, cervicitis, endometritis, PID Cervical erosion Low Birth Weight Cervical dysplasia Intellectual Disability of Baby Prolonged HPV Infection Infertility/fallopian tube damage Bacterial vaginosis Increased transmission/acquisition of HIV/HSV Presence of other STIs * Increased risk of post-surgical gynecological infections *Neisseria gonorrhoeae, Chlamydia trachomatis, human immunodeficiency virus, herpes simplex virus, and human papillomavirus 19 K Chapin MD 2014 References in appendix K Chapin MD 2014 References in appendix 20 Current Estimation of Diagnostic TV Testing Performed Presentation Outline Disease background Pathogenesis Clinical Signs and Symptoms, Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Treatment Considerations for future action Wet mount 48% BD Affirm 13% NAAT 10% OSOM 8% Wet mount/culture InPouch 29% Pap Smear % ? 21 22 K Chapin MD 2014 Wet Mount PAP Smear 23 K Chapin MD 2014 Vaginal swab in symptomatic patients Place in saline tube and then onto slide Look for motile trichomonads Needs to be done within few minutes – labs up to 2 hours….. Experienced reader… Requires live organisms and motility 45-80% sensitive K Chapin MD 2014 Fixed preparation May find TV in association with Leptothrix bacteria Poor sensitivity and poor specificity ?? If automated reading instruments pick this up since scanning for unusual cells 50% sensitive?? Spaghetti and meatballs 24 K Chapin MD 2014 4 10/16/2014 PAP Smear Rapid Antigen Detection Rapid Antigen Test Fixed preparation May find TV in association with Leptothrix bacteria Poor sensitivity and poor specificity ?? If automated reading instruments pick this up since scanning for unusual cells 50% sensitive?? K Chapin MD 2014 26 BD Affirm VP III – Detection of Bacterial vaginosis/vaginitis 27 Stable transport/no live organisms Can be done as near patient testing (usually batched) Specificity and Sensitivity? Disadvantage 28 Slide/culture media pouch Incubation 37°C Reviewed days 1,3,5,7 Advantage Subjective color endpoint Expensive (reagent, techtime) Hybridization not as sensitive for TV as NAAT May be too sensitive for normal flora? (G. vaginalis, candida) Vaginal swab only Symptomatic patients only K Chapin MD 2014 Reference Standard (2009) Candida albicans Gardnerella vaginalis (BV) Trichomonas vaginalis Disadvantages Poor sensitivity for a screening test/asymptomatic InPouch TV by BioMed – Wet mount/Culture Benefits: Vaginal swab only Symptomatic patients only Single test format No BV or candida No other STIs K Chapin MD 2014 Hybridization probe for 3 organisms: Relatively inexpensive No live organism needed Transit time not an issue Acceptable sensitivity in symptomatic patients Disadvantages: Spaghetti and meatballs 25 Point of care test - minutes Benefits: Inconvenient for collector/lab Expensive 2° to tech time Time to detection long Single Test system Not paired with other common STIs K Chapin MD 2014 APTIMA TV Assay (FDA-cleared April, 2011) HOLOGIC FDA-Cleared 2013 for TV Hologic APTIMA technology (Combo GC/CT) Nucleic Acid Amplification testing (NAAT) Single specimen collection (same tube as for other STIs GC/CT) FDA-cleared for Symptomatic and Asymptomatic women Screening and Diagnostics Urine, vaginal swab, endocervical swab in Gen-Probe transport collection device, Thin Prep liquid cytology specimen Tigris Instrument – fully automated Disadvantages No men, self-collection or alternate sites Validation has been done by labs for these purposes Tigris instrument 29 A small footprint with a width of 48", a depth of 32", and a height of 69“ 275-1000 samples per 8 hour shift – multiple assays planned pharyngeal, rectal large space and volume, cost TIGRIS K Chapin MD 2014 30 K Chapin MD 2014 5 10/16/2014 The BD Viper™ System : Up to 736 results per 8.5 hour shift 20 minutes of hands on time per run On-board sample DNA extraction Runs up to five STI assays simultaneously GC, CT, TV, HSV 1 and 2 Accuracy Flexibility BD Viper XTR Efficiency Presentation Outline FDA Cleared for TV in 2012 Strand displacement Amplification Disease background Pathogenesis Clinical Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Considerations for future action Automated sample processing and ready to use reagents Automatic system checks 31 K Chapin MD 2014 32 K Chapin MD 2014 K. Chapin MD 2011 . Comparison of commercially available diagnostic tests for TV detection in women*,^ Test OSOM Rapid Test BD Affirm VPIII TV antigen TV DNA Immunological (antibodies) Hybridization Probe <1 hour 1 hour – batched daily Near Patient Testing Yes Cost $12/test Analytical sensitivity 2,500 org/mL of sample 500,000 org/mL of sample Possible; Typically Batched 25 21.6 20 % Time to Assay Result TV Target methodology (range) % of Positive TV Tests by Wet Mount vs. APTIMA TV (n=1,086) Wet Mount APTIMA TV 15 11 10 TV rRNA TMA BD Viper TV DN A SDA *P<0.0002 5 of No sample† 0 Outpatient Phys. Emergency Dept Emergency Dept B Grp A BD assay# Urgent Care facility Munson, et al. J Clin Microbiol 2008;46:3368. 34 K Chapin MD 2014 K Chapin MD 2014 Comparison of Wet Mount, Culture, Antigen OSOM and APTIMA for TV Diagnostic Test Performance Side by Side – Same Results 98.4 96.6 100 98.4 100 90 75.4 80 60 90 83 70 60 % 50.8 50.8 54.6 50 50 40 40 30 30 20 20 10 10 0 0 Wet mount Culture OSOM Wet mount APTIMA K Chapin MD 2014 Culture Huppert Huppert, et al. Clin Inf Dis 2007; 45:194-198. 35 82.0 75.4 75 80 82.0 70 % 6 0.1 org/mL 3.5 hoursdaily *Data are from respective manufacturers † An analytical sensitivity of less than 1 organism per mL is due to the abundance of rRNA target per organism (1–3 million copies) and the TMA amplification of the target rRNA molecule # BD assay analytical sensitivity? 33 9 7 4.3 5 APTIMA 10.4 36 OSOM PCR APTIMA Nye K Chapin MD 2014 6 10/16/2014 Differences in test sensitivity stratified by the presence or absence of vaginal symptoms Comparison of TV Detection Methods Low Prevalence - RI Sensitivity % (95% CI) Test Method All Patients (n=330) Wet Mount 50.8 (37.7‐63.9) 57.5 (40.8‐72.9) 38.1 (18.1‐61.5) Culture 75.4 (62.7‐85.5) 77.5 (61.5‐89.1) 71.4 (47.8‐88.7) OSOM 82.0 (70.0‐90.6) 92.5 (79.6‐98.4) 61.9 (38.4‐81.9) ATV 98.4 (91.2‐99.9) 97.5 (86.9‐99.9) 100 (83.8‐100) 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Vaginal Symptoms Vaginal Symptoms Present (n=210) Absent (n=120) Sensitivity Specificity Huppert, et al. Clin Inf Dis 2007; 45:194-198. 37 K Chapin MD 2014 Specificity Sensitivity Affirm (n=781) 63.4% 99.9% Cx (n=446) 68.5% 100.0% Avg Sensitivity (range) Avg Specificity (range) PCR (n=766) 88.5% 100.0% TMA (n=1993) 100.0% 100.0% K Chapin MD 2014 Presentation Outline * Specificity 38 Overall reported sensitivity and specificity averages (ranges)* of TV detection methods in vaginal specimens Test Sensitivity Wet mount 60.7(43.0-83.3) 100 Culture 74.3 (57.3-94.3) 100 OSOM 84.4 (61.9-94.7) 99.8 (97.1-100) BD Affirm VPIII 63.8 (44.0-83.3) 100 (99.9-100) PCR 89.1 (83.0-100) 98.6 (96.3-100) APTIMA TV 98.1 (96.6-100) 98.9 (96.4-100) Disease background Pathogenesis Clinical Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Considerations for future action Ranges are broad due to the different “gold standard” tests used in the literature to interpret true positive infections Expert Review in Molecular Diagnostics , 2011, Chapin and Andrea 39 K Chapin MD 2014 Trichomonas in Men Infection common in men Missed diagnosis in men due to lack of testing and/or symptoms Non-reportable disease Revolving infection in partners 72% of male partners of women with TV were also positive for the infection 75% were asymptomatic 40 K Chapin MD 2014 K. Chapin MD 2011 Age Breakdown of TV Infections in Women presenting with vaginitis/vaginosis 14.0% 12.0% 10.0% 8.0% T. vaginalis C. trachomatis N. Gonorrhea 6.0% 4.0% 2.0% 0.0% ≤15 (n=13) 16 to 20 (n=119) 21 to 25 (n=150) 26 to 30 (n=92) 31 to 35 (n=64) 36 to 40 (n=50) 41 to 45 (n=36) 46 to 50 (n=40) 51 to 55 (n=14) 56 to 60 (n=9) ≥61 (n=4) Age in Years Andrea and Chapin, JCM, 2010 Hobbs et al, JCM, 2006 K 41 Chapin MD 2014 42 K Chapin MD 2014 7 10/16/2014 APTIMA Amp versus Affirm VPIII Hybridization for TV APTIMA Trichomonas vaginalis Assay Clinical trial Clinical Evaluation of the APTIMA® Trichomonas vaginalis Assay on the TIGRIS® DTS® System in Asymptomatic and Symptomatic Female Subjects P3 S7.08 ISSDTR 2010 Schwebke, Hobbs, Chapin, Taylor, Catania, Weinbaum, Getman, Gaydos Clinical assay performance was demonstrated in a prospective, multicenter clinical trial 1,025 symptomatic and asymptomatic women were enrolled from 9 U.S. clinical sites, including obstetric and gynecology, family planning, and STD clinics Performance characteristics were estimated by comparing results to a patient infected status algorithm using vaginal swab specimens tested by culture and/or wet mount microscopic examination as reference methods Published in: Schwebke, J.R. et. al. J. Clin. Microbiol. 49:4106-4111 43 K Chapin MD 2014 APTIMA Trichomonas vaginalis Assay Conclusions from Validation Study Clinical performance data For each specimen type, performance was similar in symptomatic and asymptomatic women and across collection sites Study provided clinical validation of the ATV assay for the intended uses in the United States: Sensitivity % (95% CI)* Specificity % (95% CI)* Clinician-collected vaginal swab 100.0 (96.7 – 100.0) 99.0 (97.9 – 99.5) Endocervical swab 100.0 (96.7 – 100.0) 99.4 (98.6 – 99.7) PreservCyt solution 100.0 (96.0 – 100.0) 99.6 (98.8 – 99.9) Urine 95.2 (88.4 – 98.1) 98.9 (97.8 -99.5) Specimen Type Asymptomatic Screening and Diagnostic Testing in women for Trichomonas FDA cleared highly accurate and fully automated amplified test system with ease of use specimens such as urine and vaginal swab should enhance testing for this pathogen Testing for men FDA-cleared as well would be optimal Any Amplifcation method is likely to have similar performance compared to other TV detection methods (Viper) *Sensitivity and Specificity measured at 95% CI Published in: Schwebke, J.R. et. al. J. Clin. Microbiol. 49:4106-4111 46K Chapin MD 2014 Prevalence of Trichomonas vaginalis and Co-Infection with Chlamydia trachomatis and Neisseria gonorrhoea in the United States as Determined by the APTIMA® Trichomonas vaginalis Nucleic Acid Amplification Assay Methods • Samples were obtained from 7,593 women aged 18 to 89 years undergoing routine screening for CT and GC by the APTIMA Combo 2 ® Assay • Samples were obtained from 30 laboratories in 21 states • Clinic types included: C. Ginocchio1, K. Chapin2, J. Smith3, J. Aslanzadeh4, J. Snook5, C. Hill5, C. Gaydos6 1 North Shore-LIJ Health System Laboratories, Lake Success, NY, USA; 2 Rhode Island Hospital, Providence, RI, USA; 3 University of North Carolina, Chapel Hill, NC, USA; 4 Hartford Hospital and Clinical Laboratory Partners, Hartford, CT, USA; 5 Gen-Probe Incorporated, San Diego, CA, USA; 6 Johns Hopkins University School of Medicine, Baltimore, MD, USA • Determine the prevalence of Trichomonas vaginalis (TV) using the APTIMA Trichomonas vaginalis (ATV) assay among women being screened for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in the United States • Determine the co-infection rates of TV, CT and NG • • • • • • • • 47 K Chapin MD 2014 OB/Gyn clinics Emergency room Hospital in-patient Family practice Family planning Internal medicine Jail STD clinics 48 K Chapin MD 2014 8 10/16/2014 Geographic Prevalence of TV, CT and GC Infections Prevalence of TV, CT, and GC Infections by Age Overall Prevalence N* TV+ 7593 8.70% (663/7593) % (n/N*) CT+ GC+ 6.70% 1.70% (508/7588) (129/7579) Age Mean (SD) Median (min-max) 29.82 (10.62) 26 (18-82) 23.4 (6.0) 22 (18-65) 24.0 (6.9) 22 (18-53) 8.50% 8.30% 7.90% 11.30% 13.00% 14.40% 8.00% 2.50% 1.90% 0.90% 3.30% 2.00% 0.80% 0.10% 1.20% Prevalence (%)* by Age Group 18-19 20-29 30-39 40-49 50+ 907 3972 1667 720 324 * In the calculations of prevalence, the denominator may be less than that the N shown due to missing or invalid assay data. 49 K Chapin MD 2014 50 K Chapin MD 2014 Prevalence of TV, CT, and GC Infections by Age Prevalence of TV, CT, and GC Co-infections by Age Overall Prevalence N* CT+GC+TV+ CT+TV+ CT+GC+ GC+TV+ 7593 0.24% (18/7577) 1.30% (97/7588) 0.61% (46/7577) 0.61% (46/7579) % prevalence % (n/N*) Age 22.00 (2.35) 21.5 (18-26) Mean (SD) Median (min-max) 23.41 (5.49) 21.89 (3.78) 23.15 (5.53) 22 (18-46) 21 (18-37) 21.5 (18-50) Prevalence (%)* by Age Group 907 3972 1667 720 324 18-19 20-29 30-39 40-49 50+ age 51 0.20% 0.40% 0.00% 0.00% 0.00% 2.10% 1.70% 0.40% 0.40% 0.00% 1.30% 0.83% 0.10% 0.00% 0.00% 0.90% 0.90% 0.20% 0.00% 0.30% * In the calculations of prevalence, the denominator may be less than that the N shown due to missing or invalid assay data. K Chapin MD 2014 52Chapin MD K 2014 Prevalence of TV, CT, and GC Infections by Collection Site % prevalence Prevalence of TV, CT, and GC Infections by Race K 53 Chapin MD 2014 54 K Chapin MD 2014 9 10/16/2014 Conclusions from Prevalence Study Ginnochio et al • TV prevalence (8.7%) is higher than CT (6.7%) and GC (1.7%) • TV prevalence is highest in women >40 years (>11%), while CT and GC prevalence is lowest in that age group (<2%) • TV prevalence is highest among black women (20.2%) • Co-infection of TV with CT and/or GC was relatively low and highest in women <20 years • TV prevalence was highest in jail (22.3%) and emergency room (17.0%) collection sites • The high TV prevalence in all age groups suggests that all women being screened for CT/GC should also be screened for TV J. Clin. Microbiol. 51: 101-104; 2013 Presentation Outline Disease background Pathogenesis Clinical Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Treatment Considerations for future action 57 K Chapin MD 2014 Presentation Outline K. Chapin MD 2014 56 55K Chapin MD 2014 Treatment of TV Single 2 g oral metronidazole Vaginal gel not as effective (most commonly used for BV) Tinidazole Twice the ½ life of metro (12-14 hrs) Better tolerated True resistance < 10%; can be overcome with higher dosing Therapy is ineffective if partner is not treated! Treating for BV is not the same as treating for TV 58 K Chapin MD 2014 Diagnostic Problem with TV… What is it? A vaginal nuisance or an STI? Disease background Pathogenesis Clinical Sequelae Current TV detection methods Comparison of methods with NAAT Trichomonas epidemiology clarified Treatment Considerations for future action 59 K Chapin MD 2014 60 K. Chapin MD 2014 10 10/16/2014 Getting TV on the Map Educate the healthcare providers Educate the public/patient (Chapin’s PR campaign?) K Chapin MD 2014 Did you know the most common treatable STI is one that your physician may not be testing for?? What STD is a college student’s MOM more likely to have then their college student? Educate the Laboratory 61 Don’t know the prevalence or the sequelae Trichomoniasis is not always associated with symptoms, age or obvious sexual risk behaviors Know the benefits/disadvantages of current tests methods Many labs/providers do wet mount and think it is OK K 62 Chapin MD 2012 Implementation of Trichomonas Testing Combined Concerted Effort PUBLIC HEALTH LABS 63 K Chapin MD 2014 HEALTHCARE PROVIDERS Insurance PATIENT 64 K Chapin MD 2014 66 K Chapin MD 2014 The STD you have heard of…and are going to do something about it….. 65 K Chapin MD 2014 11 10/16/2014 References Hobbs MM, Lapple DM, Lawing LF et al. Methods for Detection of Trichomonas vaginalis in the Male Partners of Infected Women: Implications for Control of Trichomoniasis. Journal of Clinical Microbiology, 44(11), 3994-3999 (2006). Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. American Journal of Obstetrics and Gynecology, 200(2), 188.e181-188.e187 (2009). Andrea SB, Chapin KC. Comparison of APTIMA® Trichomonas vaginalis transcription-mediated amplification assay and BD Affirm VPIII for detection of Trichomonas vaginalis in symptomatic women: Performance parameters and epidemiologic implications. Journal of Clinical Microbiology, 49(3), 866-869 (2011). Centers for Disease Control and Prevention (CDC). Sexually Transmitted Diseases Treatment Guidelines, 2010. Morbidity and Mortality Weekly Report, 59(RR-12) (2010). CID, 2013 Baron et al, A guide to Utilization of the Microbiology Laboratory for the Diagnosis of Infectious Diseases CAP today Jan 2013 Huppert J, Mortensen J, Reed J et al. Rapid antigen testing compares favorably with transcription-mediated amplification assay for the detection of Trichomonas vaginalis in young women. Clinical Infectious Disease, 45(2), 194-198 (2007). Munson E, Napierala M, Olson R et al. Impact of Trichomonas vaginalis Transcription-Mediated Amplification-Based AnalyteSpecific-Reagent Testing in a Metropolitan Setting of High Sexually Transmitted Disease Prevalence. Journal of Clinical Microbiology, 46(10), 3368-3374 (2008). Chapin K, Andrea, S. APTIMA Trichomonas vaginalis, a transcription-mediated amplification assay for detection of Trichomonas vaginalis in urogenital specimens. Expert Review in Molecular Diagnostics. Sept. 2011. Schwebke, J. Mandell’s 7th edition. Trichomonas vaginalis online text 67 K Chapin MD 2014 12