Suboptimal \u3cem\u3eTrichomonas vaginalis\u3c/em\u3e Antigen Test Performance in a Low-Prevalence Sexually Transmitted Infection Community

Trichomonas vaginalis is the most common nonviral etiology of sexually transmitted infection (STI) worldwide. The OSOM Trichomonas rapid test (OSOM; Sekisui Diagnostics, San Diego, CA) is a rapid surrogate to microscopic analysis in symptomatic patients, but its performance in low-prevalence STI populations has been assessed on a limited basis in the literature. OSOM has widespread usage, as accreditation data from the College of American Pathologists report that over 300 participant laboratories utilize this assay on an annual basis. We sought to characterize the analytical and clinical performance of OSOM in a low-prevalence STI population on the basis of a commercial transcription-mediated amplification (TMA) reference

Update on Laboratory Diagnosis and Epidemiology of \u3cem\u3eTrichomonas vaginalis\u3c/em\u3e: You Can Teach an “Old” Dog “New” Trichs

Past viewpoints on Trichomonas vaginalis infection have characterized the associated clinical disease as a “nuisance” condition, with affected demographics largely being older African American females residing in urban centers. The advent of commercial molecular assays specific for T. vaginalis has offered a new outlook on trichomoniasis. Within high-prevalence sexually transmitted infection populations, parasite distribution is not localized to specific population centers, and T. vaginalis prevalence is elevated among both younger and older age groups. Adaptation of these molecular assays can additionally facilitate male screening and subsequent epidemiologic characterization. These findings, combined with associations between T. vaginalis infection and human immunodeficiency virus (HIV) acquisition/transmission and persistent human papillomavirus infection, support consideration of the expansion of T. vaginalis screening efforts in the realms of clinical practice and public health

Application of Alternative Nucleic Acid Extraction Protocols to ProGastro SSCS Assay for Detection of Bacterial Enteric Pathogens

As an alternative to automated extraction, fecal specimens were processed by investigational lysis/heating (i.e., manual) and by chromatography/centrifugation (i.e., column) methods. ProGastro SSC and Shiga toxin-producing Escherichia coli (i.e., STEC) indeterminate rates for 101 specimens were 1.0% to 3.0% for automated, 11.9% for manual, and 24.8% to 37.6% for column methods. Following freeze-thaw of 247 specimens, indeterminate rates were 1.6% to 2.4% for manual and 0.8 to 5.3% for column methods. Mean processing times for manual and column methods were 30.5 and 69.2 min, respectively. Concordance of investigational methods with automated extraction was ≥98.8%

Clinical Laboratory Assessment of \u3cem\u3eMycoplasma genitalium\u3c/em\u3e Transcription-Mediated Amplification Using Primary Female Urogenital Specimens

Following analysis of primary cervix, vagina, and first-void female urine specimens for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis via commercial transcription-mediated amplification (TMA), residual material was subjected to Mycoplasma genitalium research-use-only TMA. Representation within a 2,478-specimen retrospective study set was established by comparison to a 6-month audit of clinical C. trachomatis TMA (12,999 specimens) on the basis of the C. trachomatis detection rate, specimen source distribution, clinic location, and age. M. genitalium was detected in 282 (11.4%) patients. This rate was higher than those seen with T. vaginalis (9.0%; P _ 0.005), C. trachomatis (6.2%), and N. gonorrhoeae (1.4%). Positive M. genitalium results were confirmed by repeat testing or alternative-target TMA at a rate of 98.7%. The mean age of the M. genitalium-infected females (24.7 years) was lower than that of the T. vaginalis-infected females (mean, 30.1 years; P\u3c0.0001) and higher than that of the C. trachomatis-infected females (mean, 23.8 years; P_0.003). Of 566 patient encounters positive for at least one sexually transmitted infection (STI), 35.9% exhibited sole detection of M. genitalium (P \u3c 0.0004 versus sole detection of other STI agents) and 26.1% were solely positive for T. vaginalis (P \u3c 0.0002 versus C. trachomatis). The M. genitalium and T. vaginalis detection rates among 755 patients at urban emergency departments were 14.6% and 13.0%, respectively (P _ 0.37). A 10.0% M. genitalium detection rate from other facilities exceeded that of T. vaginalis (7.2%; P _ 0.004). Incorporation of M. genitalium TMA into comprehensive testing programs would detect M. genitalium in a significant proportion of females, particularly those in outpatient obstetrics and gynecology (OB/GYN) settings

Expansion of Comprehensive Screening of Male Sexually Transmitted Infection Clinic Attendees with \u3cem\u3eMycoplasma genitalium\u3c/em\u3e and \u3cem\u3eTrichomonas vaginalis\u3c/em\u3e Molecular Assessment: a Retrospective Analysis

Of 1,493 encounters of males at a sexually transmitted infection (STI) clinic in a community with a high prevalence of STI, Chlamydia trachomatis was detected in 8.7% and Neisseria gonorrhoeae was detected in 6.6%. Additional Trichomonas vaginalis and Mycoplasma genitalium screening found 17.4% and 23.9% of the encounters, respectively, to be positive for STI. STI agents were detected in 13.7% of urine specimens; addition of pharyngeal and rectal collections to the analysis resulted in detection of STI agents in 19.0% and 23.9% of encounters, respectively. A total of 101 (23.8%) encounters of identified STI involved sole detection of M. genitalium. Expansion of the STI analyte panel (including M. genitalium) and additional specimen source sampling within a comprehensive STI screening program increase identification of male STI carriers

Clinical Laboratory Assessments for \u3cem\u3eMycoplasma genitalium\u3c/em\u3e in a High-Prevalence Sexually-Transmitted Infection Community Reveal Epidemiologic Dichotomies with \u3cem\u3eTrichomonas vaginalis\u3c/em\u3e

Introduction. Mycoplasma genitalium is an emerging agent of sexually-transmitted infection and is responsible for clinically-significant genital tract disease in both females and males. Similar to scenarios recently experienced with the urogenital flagellate Trichomonas vaginalis, an evolving molecular diagnostic reference standard based on transcription-mediated amplification allows for accurate detection of the organism, plus additional insight into disease epidemiology. Areas covered. The basis for this article includes primary peer-reviewed literature plus compilations of data derived from routine clinical laboratory screening of females and males for agents of sexually-transmitted infection. Introductory laboratory and epidemiologic data related to T. vaginalis provides not only a foreshadowing to the dichotomies inherent to M. genitalium prevalence but also advocacy of a common non-invasive specimen source that could be used to screen females for both agents. This review also documents increased prevalence rates of M. genitalium in both females and males by way of transcription-mediated amplification. Expert commentary. Molecular detection of M. genitalium should be a consideration in the development of comprehensive sexually-transmitted infection screening programs for both females and males. Transcription-mediated amplification has additionally identified novel facets of M. genitaliumand T. vaginalis epidemiology that warrant further investigation