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Trichomonas Vaginalis: Common, Curable and in the Diagnostic Spotlight

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Trichomonas Vaginalis: Common, Curable and in the Diagnostic Spotlight FOCUS: MOLECULAR DIAGNOSIS OF SEXUALLY TRANSMITTED INFECTIONS Trichomonas vaginalis: Common, curable and in the diagnostic spotlight CHRIS L. MCGOWIN, RODNEY E. ROHDE, GERALD REDWINE LEARNING OBJECTIVES tology, 1901 Perdido St.; MEB 6214, New Orleans, LA 1. Discuss the historical and epidemiological spectra 70112-2822, 504 568-7281, [email protected] of Trichomonas vaginalis. Trichomonas vaginalis is the most common curable 2. Define the clinical characteristics of trichomoniasis Downloaded from in men and women. sexually transmitted infection (STI) worldwide.1 The 3. Explain the methods for clinical diagnosis of T. 2001-2004 National Health and Nutrition vaginalis infection. Examination Surveys (NHANES) report that American 4. Compare and contrast the treatment strategies for women between the ages of 14 and 49 are infected with trichomoniasis in women. T. vaginalis with a prevalence of approximately 3% - 2,3 greater than that of C. trachomatis and N. gonorrhoeae. http://hwmaint.clsjournal.ascls.org/ ABBREVIATIONS: CDC - Centers for Disease Additional studies have highlighted that, unlike C. Control and Prevention, FDA - Food and Drug trachomatis and N. gonorrhoeae, T. vaginalis affects all Administration, MDx - molecular diagnostics, NAAT - age groups and the prevalence is highest in women over nucleic acid amplification test, NGU - non-gonococcal 40 years of age.4-7 Annually, it is estimated that more urethritis, NHANES - National Health and Nutrition than half of the approximately 248 million new T. Examination Surveys, PID - pelvic inflammatory vaginalis infections occur in males worldwide.1 disease: POC - point of care, PPV - positive predictive However, the majority of prevalent T. vaginalis value, STD - sexually transmitted disease, STI - sexually infections are detected in women, which is consistent transmitted infection with the chronic nature of these infections in the female urogenital tract. Most infections in women are on September 24 2021 INDEX TERMS: Molecular diagnostics, sexually asymptomatic, however T. vaginalis has been linked to transmitted disease, sexually transmitted infections, lower and upper reproductive tract disease syndromes Trichomonas vaginalis, trichomoniasis including vaginitis, cervicitis and pelvic inflammatory disease (PID). Pregnancy-related complications include Clin Lab Sci 2014;27(1):53 pre-term birth and infertility. In men, T. vaginalis is most commonly a cause of non-gonococcal urethritis Chris L. McGowin, PhD, Louisiana State University (NGU) but infections tend to be transient and Health Sciences Center, Department of Microbiology, frequently asymptomatic. In this article, we concisely Immunology and Parasitology, New Orleans, LA discuss the current knowledge on T. vaginalis epidemiology and the developing trends in diagnosis of Rodney E. Rohde, PhD, MS, SV, SM(ASCP)CM, MBCM, this incredibly prevalent STI. Clinical Laboratory Science Program, College of Health Professions, Texas State University, San Marcos, TX Disease spectrum of T. vaginalis infections Currently, trichomoniasis is not a notifiable disease in Gerald Redwine MEd, MT(ASCP), Clinical Labora- the USA and so therefore, compared to other STIs, tory Science Program, College of Health Professions, Texas relatively little is known about the epidemiology and State University, San Marcos, TX pathogenesis of T. vaginalis infections. The spectrum of disease in women is characterized by symptoms of Address for Correspondence: Chris L. McGowin, PhD, vaginitis including discharge, and localized vulvar Louisiana State University Health Sciences Center, pruritus. Classical disease signs include purulent vaginal Department of Microbiology, Immunology and Parasi- discharge, and vaginal and vulvar erythema. The urethra VOL 27, NO 1 WINTER 2014 CLINICAL LABORATORY SCIENCE 53 FOCUS: MOLECULAR DIAGNOSIS OF SEXUALLY TRANSMITTED INFECTIONS is commonly infected with accompanying symptoms of Although both techniques rely upon a trained dysuria in women with vaginal infection. In addition, microscopist, wet mount microscopy and culture colpitis macularis, or “strawberry cervix” is a highly methods are highly specific for T. vaginalis detection specific sign of infection but is only accurately (>99%)11,13 primarily due to the characteristic tumbling diagnosed during colposcopy. The dogmatic notion that motility of viable organisms. T. vaginalis infections are overtly symptomatic in women has been unequivocally overturned. In fact, up Microscopy-based techniques were followed by the first to 80% of T. vaginalis infections are asymptomatic in generation of nucleic acid amplification tests (NAATs). women depending on the clinical setting.3 Despite the Collectively, NAATs have dramatically enhanced our asymptomatic nature of infection, T. vaginalis has been understanding of T. vaginalis epidemiology, linked to several inflammatory syndromes in women pathogenesis, and helped to identify a previously thus highlighting the importance for screening underappreciated population of asymptomatic initiatives in subjects at risk for STIs. T. vaginalis infections in men and women. Contemporary NAATs Downloaded from infection in women is also associated with increased are both highly specific and sensitive, and several have susceptibility to HIV acquisition and HIV shedding in been adapted to high-throughput instrumentation. co-infected individuals. In males, T. vaginalis is most Unlike microscopy, NAATs require no subjective commonly a cause of NGU but infection is frequently interpretation of the test results and have faster turn- asymptomatic and the majority of cases are reported to around times compared to culture. Enhanced sensitivity http://hwmaint.clsjournal.ascls.org/ clear spontaneously within 10 days.8-11 Together, the is the clear advantage of NAATs compared to culture importance of asymptomatic males as transmitters to and wet mount microscopy. The most widely used women is enormous since T. vaginalis infections in culture methods utilize the InPouch TV (BioMed women, with or without symptoms, can persist for at Diagnostics, White City, OR) device or inoculation of least several months.11 Like the bacterial STIs, specimen material into Diamond’s medium. These tests complicated T. vaginalis infections in men can lead to are moderately sensitive ranging from 44-75%13 and more severe inflammatory outcomes including require three to seven days before results are available. prostatitis, urethral stricture, epididymitis and 12 infertility. It was not until the late 1990’s when the first NAAT was FDA-approved for diagnostic testing in the USA. Diagnosis of Trichomoniasis Currently, development and implementation of T. on September 24 2021 The history of T. vaginalis diagnostics dates back to the vaginalis testing platforms into clinical laboratories are early part of the 19th century when motile organisms top industry priorities in the realm of STI diagnostics. were visible on wet mount preparations of vaginal swab As of this 2014 publication, only two NAATs are FDA- specimens. Strikingly, direct microscopic observation approved and marketed for T. vaginalis detection in the remained the standard of diagnostic care until in vitro USA: 1) the APTIMA TV test (GenProbe, Inc., San culture methods were introduced in 1949.11 Several Diego, CA) for use on the TIGRIS and PANTHER studies have reported low sensitivities of T. vaginalis platforms; and 2) the ProbeTec Trichomonas vaginalis detection using wet mount microscopy that range from Qx Amplified DNA Assay for use on the BD Viper 44-68%.13 In addition, sensitivity can be negatively platform (Beckton Dickinson, Franklin Lakes, NJ). impacted by even short time intervals (10-30 minutes) Targeting a conserved region of 16s rRNA molecules, between swab collection and microscopic examination.14 the APTIMA TV test utilizes the combined Despite low sensitivity and the need for rapid technologies of transcription medicated amplification processing, microscopy remains the most commonly (TMA) and a hybridization protection assay (HPA). By used technique for diagnosis of trichomoniasis due to targeting a high-copy transcript in the T. vaginalis cell, ease and cost-effectiveness. Culture of trichomonads the FDA-approved APTIMA TV test is characterized by from female urogenital specimens using Diamond’s very high sensitivity values ranging from 95-100% broth medium is substantially more sensitive compared depending on the specimen type and gold standard 13 to wet mount microscopy (96% vs. 36-82%, comparator. According to the manufacturer’s package 11 respectively) but requires additional supplies and insert, sensitivity values range from 92-100% for the x equipment including an incubator for growing cultures. ProbeTec Trichomonas vaginalis Q Amplified DNA 54 VOL 27, NO 1 WINTER 2014 CLINICAL LABORATORY SCIENCE FOCUS: MOLECULAR DIAGNOSIS OF SEXUALLY TRANSMITTED INFECTIONS Assay among both symptomatic and asymptomatic paradigms for men are lacking considering the women when compared to a composite comparator of substantial number of incident infections. wet mount and culture. The ProbeTec assay utilizes strand displacement assay (SDA) technology as Treatment of T. vaginalis infections described previously.15 Taken together, modern NAATs Effective therapies for T. vaginalis infections are substantially improve sensitivity of T. vaginalis available for men and women diagnosed with detection from several specimen types, and serve both as trichomoniasis. The current CDC-recommended first- diagnostic and screening tools
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