Three-Year History of Transcription-Mediated Amplification-Based Trichomonas vaginalis Analyte-Specific Reagent Testing in a Subacute Care Patient Population

Napierala, Maureen; Munson, Erik; Munson, Kimber L.; Kramme, Timothy; Miller, Cheryl N.; Burtch, Jason; Olson, Robin; Hryciuk, Jeanne E.

doi:10.1128/jcm.05632-11

Cited by 12 publications

(16 citation statements)

References 33 publications

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“…Therefore, comparison of performance characteristics by specimen source could not be accomplished in this retrospective assessment. Of further interest, previous studies in our female patient population demonstrated increased T. vaginalis detection from first-void urine specimens (25,35). We also show increased T. vaginalis detection from first-void urine compared to cervical specimens (P ϭ 0.04; Fig.…”

Section: Discussionsupporting

confidence: 62%

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Clinical Laboratory Assessment of Mycoplasma genitalium Transcription-Mediated Amplification Using Primary Female Urogenital Specimens

et al. 2016

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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 < 0.0001) 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 < 0.0004 versus sole detection of other STI agents) and 26.1% were solely positive for T. vaginalis (P < 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. T he sexually transmitted infection (STI) agentMycoplasma genitalium has historically had a role of pathogenicity in male nongonococcal urethritis (1). Recent evidence has implicated the bacterium in clinically significant disease in females (2, 3). Additional studies suggest that M. genitalium infection promotes HIV acquisition (4-6) and virus shedding (7,8). Moreover, in a recent meta-analysis, Lis et al. (9) reported significant associations between M. genitalium infection and cervicitis, pelvic inflammatory disease, preterm birth, and spontaneous abortion.Until recently, a lack of reliable testing options has curtailed laboratory diagnosis of M. genitalium infection. Culture and serologic modalities have been limited by sensitivity and/or cross-reactivity with other mycoplasmas (1) and are becoming supplanted by molecular diagnostics, largely on a research basis. PCR-based assays have correlated M. genitalium DNA burden with clinical condition (10, 11) and treatment efficacy (12) in males. Quantitative molecular analysis has sought to study progression of genital disease in females (13). In the realm of laboratory diagnosis, initial studies of target capture-based transcription-mediated amp...

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Section: Discussionsupporting

confidence: 62%

“…Prior to FDA clearance in 2011, T. vaginalis TMA was also commercially available as an ASR. Napierala et al (35) demonstrated progressively increased utilization of that assay over a 3-year interval. Should an analogous pattern be observed …”

Section: Discussionmentioning

confidence: 99%

Clinical Laboratory Assessment of Mycoplasma genitalium Transcription-Mediated Amplification Using Primary Female Urogenital Specimens

et al. 2016

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“…In spite of trichomoniasis largely presenting as vulvovaginitis, T. vaginalis analyte-specific reagent (ASR)-derived data describe the value of endocervical samplings for molecular T. vaginalis detection (19,22,24). In addition, preliminary data suggest increased T. vaginalis detection from first-void urine specimens compared to that from vaginal and cervical specimens (1,21).…”

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confidence: 91%

“…However, sexually transmitted infection (STI) prevalence limitations were inherent to these two reports. Napierala et al (21) summarized operational characteristics of T. vaginalis ASR using a highprevalence STI metropolitan area. That study served as the basis for the presented investigation.…”

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Female Epidemiology of Transcription-Mediated Amplification-Based Trichomonas vaginalis Detection in a Metropolitan Setting with a High Prevalence of Sexually Transmitted Infection

et al. 2012

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bRecent literature has reported increased accuracy of Trichomonas vaginalis transcription-mediated amplification (TMA)-based analyte-specific reagent (ASR) testing in female populations. A retrospective investigation assessed 7,277 female first-void urine, cervical, or vaginal specimens submitted from a high-prevalence sexually transmitted infection (STI) community to characterize prevalence of disease etiologies. The most common STI phenotype reflected detection of solely T. vaginalis (54.2% of all health care encounters that resulted in STI detection). In females with detectable T. vaginalis, codetection of Chlamydia trachomatis and Neisseria gonorrhoeae occurred in 7.8% and 2.7% of health care encounters, respectively. The mean age of women with detectable T. vaginalis (30.6) was significantly higher than those for women with C. trachomatis or N. gonorrhoeae (22.3 and 21.6, respectively; P < 0.0001). T. vaginalis was the predominant sexually transmitted agent in women over the age of 20 (P < 0.0002). C. trachomatis was the most commonly detected agent in females under the age of 21, particularly from cervical specimens. However, first-void urine detection rates for T. vaginalis and C. trachomatis within this age demographic demonstrated no difference (P ‫؍‬ 0.92). While overall and cervical specimen-derived detection of T. vaginalis within African American majority geographical locales outweighed that within majority Caucasian geographical regions (P < 0.004), this difference was not noted with first-void urine screening (P ‫؍‬ 0.54). Health care professionals can consider TMA-based T. vaginalis screening for a wide age range of patients; incorporation of first-void urine specimens into screening algorithms can potentiate novel insight into the epidemiology of trichomoniasis.

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“…A previous assessment of T. vaginalis TMA showed 100% molecular concordance between the data from vaginal saline suspension aliquots and endocervical specimens maintained in Aptima specimen transport tubes (7). In addition, Napierala et al (8) have shown equivalent T. vaginalis TMA detection rates from endocervical swabs and vaginal swabs in our population. This study was governed by the Wheaton Franciscan Healthcare Institutional Review Board.…”

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confidence: 75%

Suboptimal Trichomonas vaginalis Antigen Test Performance in a Low-Prevalence Sexually Transmitted Infection Community

2016

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bT richomonas vaginalis is the most common nonviral etiology of sexually transmitted infection (STI) worldwide (1). The OSOM Trichomonas rapid test (OSOM; Sekisui Diagnostics, San Diego, CA) is a rapid surrogate to microscopic analysis in symptomatic patients (2), but its performance in low-prevalence STI populations has been assessed on a limited basis in the literature (3). 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 (4). 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.Results from the performance of OSOM with 1,421 consecutive vaginal saline suspensions were audited from a 4-month interval in a low-prevalence southeastern Wisconsin STI population (5). The concomitant Aptima specimen transport tube from the health care encounter (98.7% endocervical, 1.3% vaginal), previously subjected to Chlamydia trachomatis and Neisseria gonorrhoeae TMA (Aptima Combo 2 assay; Hologic, San Diego, CA), was forwarded for retrospective T. vaginalis TMA (Aptima Trichomonas vaginalis assay; Hologic) evaluation on a TIGRIS direct tube sampling (DTS) system per the manufacturer's specifications (6). A previous assessment of T. vaginalis TMA showed 100% molecular concordance between the data from vaginal saline suspension aliquots and endocervical specimens maintained in Aptima specimen transport tubes (7). In addition, Napierala et al. (8) have shown equivalent T. vaginalis TMA detection rates from endocervical swabs and vaginal swabs in our population. This study was governed by the Wheaton Franciscan Healthcare Institutional Review Board.The low-prevalence STI population exhibited TMA detection rates of 6.4% and 0.6% for C. trachomatis and N. gonorrhoeae, respectively, while the T. vaginalis TMA detection rate was 4.0%. On the basis of a T. vaginalis TMA reference standard, the sensitivity and specificity of OSOM were 35.1% and 99.9%, respectively (Table 1). The kappa value for this data set was 0.502 (95% confidence interval, 0.346 to 0.658), and agreement was 0.973 (95% confidence interval, 0.963 to 0.981).In an analogous fashion, 98 consecutive tandem vaginal saline suspensions and endocervical swabs from an increased-prevalence STI setting (C. trachomatis TMA detection rate, 11.2%; N. gonorrhoeae TMA detection rate, 6.1%; setting characterized previously [7,9]) were retrospectively analyzed via OSOM and T. vaginalis TMA, respectively, per the manufacturer's guidelines (2, 6). Improved concordance between OSOM and T. vaginalis TMA was observed within this study set, with a 21.4% T. vaginalis TMA detection rate (Table 2). An increased kappa value of 0.904 (95% confidence interval, 0.797 to 1.000) was calculated, with agreement of 0.969 (95% confidence interval, 0.907 to 0.992).Campbell et al. (3) reported 94.7% sensitivity for OSOM compared to microscopy in a ...

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Three-Year History of Transcription-Mediated Amplification-Based Trichomonas vaginalis Analyte-Specific Reagent Testing in a Subacute Care Patient Population

Cited by 12 publications

References 33 publications

Clinical Laboratory Assessment of Mycoplasma genitalium Transcription-Mediated Amplification Using Primary Female Urogenital Specimens

Clinical Laboratory Assessment of Mycoplasma genitalium Transcription-Mediated Amplification Using Primary Female Urogenital Specimens

Female Epidemiology of Transcription-Mediated Amplification-Based Trichomonas vaginalis Detection in a Metropolitan Setting with a High Prevalence of Sexually Transmitted Infection

Suboptimal Trichomonas vaginalis Antigen Test Performance in a Low-Prevalence Sexually Transmitted Infection Community

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