Use of an Immunochromatographic Assay for Rapid Detection of
            <i>Trichomonas vaginalis</i>
            in Vaginal Specimens

Huppert, Jill S.; Batteiger, Byron E.; Braslins, Phillip G.; Feldman, James A.; Hobbs, Marcia M.; Sankey, Heather; Seña, Arlene C.; Wendel, Karen A.

doi:10.1128/jcm.43.2.684-687.2005

Cited by 102 publications

(63 citation statements)

References 19 publications

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“…Interestingly, women who were 36 to 45 years old had no C. trachomatis or N. gonorrhea infections but had significantly more T. vaginalis infections than women who were 16 to 25 years old (P ϭ 0.005, odds ratio [OR] ϭ 3.1, 95% confidence interval [95% CI] ϭ 1.4 to 6.6). While this statistically significant double peak is consistent with symptomatic-and asymptomatic-general-population data from our institution (7a), other studies have also shown the unique prevalence of T. vaginalis in an age group outside the recommended STI screening age groups (11,16 A total of 316 (41.3%) patient specimens were found to be positive for G. vaginalis by the Affirm assay. This seems quite high given the low prevalence of STIs in the population studied; however, all patients were symptomatic with vaginal complaints which may have selected for a more highly infected patient group.…”

Section: Discussionsupporting

confidence: 88%

Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications

Andrea

Chapin

2011

J Clin Microbiol

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Trichomonas vaginalis is an underestimated sexually transmitted infection (STI) associated with numerous clinical sequelae. The true prevalence and clinical impact of trichomoniasis are unknown, as current methods of detection exhibit poor sensitivity compared to molecular amplification methods. Limited data exist comparing the BD Affirm VPIII hybridization assay to the Gen-Probe Aptima T. vaginalis (ATV) transcriptionmediated amplification (TMA) assay for detection of T. vaginalis. In this study, specimens from 766 patients were evaluated. Specimens were retrieved consecutively from patients with vaginal complaints and/or with histories suggestive of STI. Study inclusion was dependent upon the request for and collection of both a vaginal swab for Affirm and a specimen for Aptima Combo 2 by the health care provider during the same office visit. Affirm was performed using the specific collection swab and the transport provided for the test. The ATV assay was performed on remnant Aptima Combo 2 specimens. A second ATV TMA assay, utilizing an alternate T. vaginalis primer and probe set, was performed on all specimens positive by the initial TMA and/or the Affirm assay. Infected-patient status was defined as positive T. vaginalis test results by at least 2 assays. Overall, 5.1% of subjects were positive for T. vaginalis. T. vaginalis was most prevalent in women who were 36 to 45 (11.9%), 51 to 60 (7.7%), and 16 to 25 (4.2%) years of age. The ATV assay was statistically more sensitive than the Affirm assay (100% versus 63.4%, P < 0.0001), identifying 36.6% more positive patients.Despite a worldwide prevalence rate likely to be double that of Neisseria gonorrhea and Chlamydia trachomatis combined, Trichomonas vaginalis is not currently a reportable disease in the United States (1, 7). Recent literature suggests an association between T. vaginalis infection and the sequelae of other sexually transmitted infections (STIs), including low birth weight, premature rupture of membranes, preterm labor, atypical pelvic inflammatory disease, infertility, prolonged carriage of human papillomavirus (HPV), and an increased risk for acquiring HIV (9,10,13,18,21,31,32). Current methods used for the diagnosis of T. vaginalis, including wet mount microscopy, rapid antigen testing, and culture, have been shown to have poor sensitivity compared to molecular amplification methods (6,14,17,19,24,25,27). In addition, variable performance occurs with antigen testing and wet mount microscopy, depending on whether patients are symptomatic or asymptomatic (17, 26). The BD Affirm VPIII (Affirm) assay (Becton Dickinson, Sparks, MD) is the only Food and Drug Administration (FDA)-cleared, direct-specimen, RNA probebased diagnostic test designed to differentiate and identify pathogens associated with bacterial vaginosis (Gardnerella vaginalis) and vaginitis (T. vaginalis and Candida species). The Affirm test is widely used, yet limited data exist comparing this test with other molecular methods (5).The purpose of this study was to evaluate the perf...

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Section: Discussionsupporting

confidence: 88%

Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications

Andrea

Chapin

2011

J Clin Microbiol

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“…The value of our large data set also applies to age delineation of T. vaginalis detection. Past studies (11,27) showed increased T. vaginalis prevalence in older age groups but did not have the benefit of highly sensitive TMA (3,13,23). One account derived from TMA analysis (1) also reported this phenomenon but did not demonstrate C. trachomatis or N. gonorrhoeae detection in patients beyond ages 26 to 30.…”

Section: Epidemiology Of T Vaginalis In Femalesmentioning

confidence: 99%

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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“…It is cleared by the FDA for use on a direct vaginal swab or on used wet-mount saline. Its reported sensitivity (85 to 90%) and specificity (100%) are similar to those of culture (7,8). In addition, transcription-mediated amplification is a nucleic acid amplification test (NAAT) method that uses analyte-specific reagents for T. vaginalis.…”

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confidence: 99%

Stepwise Diagnosis of Trichomonas vaginalis Infection in Adolescent Women

Pattullo

Griffeth

Ding³

et al. 2009

J Clin Microbiol

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The objective of this study was to examine the effects of clinical factors and of the type and timing of a secondary test in improving the sensitivity of Trichomonas vaginalis detection in young women over that of a wet mount alone. For this purpose, sexually active adolescent women (n ‫؍‬ 345) were recruited from a hospital teen clinic or emergency department. Following an interview and a pelvic exam, four primary T. vaginalis tests (wet mount, culture, a rapid test, and a nucleic acid amplification test [NAAT]) were performed on vaginal swabs. If the wet-mount result was negative, two secondary tests (culture and a rapid test) were performed on the used wet-mount swab and saline. A positive result by any of the four primary tests was considered a true T. vaginalis-positive result. The prevalence of T. vaginalis was 18.8% overall and 8.8% in the 307 wet-mountnegative women. There was 100% concordance between primary and secondary rapid tests. Secondary culture was 80% sensitive compared to primary culture. The likelihood of a positive rapid test increased with increasing time between specimen collection and testing. A wet mount followed by a rapid test was the most sensitive strategy using two tests (86.4%; confidence interval [CI], 75.3 to 93.4%). Limiting secondary testing to those with multiple partners resulted in a lower sensitivity (73.9%; CI, 61.5 to 84%) that was not significantly better than that of the wet mount alone (58.5%; CI, 45.6 to 70.6%). We conclude that a rapid test can be delayed or performed on a used swab with no loss of sensitivity. Until a NAAT for T. vaginalis is commercially available, a stepwise approach using an additional rapid test for wet-mount-negative women is recommended for adolescent women regardless of clinical factors.

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Use of an Immunochromatographic Assay for Rapid Detection of Trichomonas vaginalis in Vaginal Specimens

Cited by 102 publications

References 19 publications

Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications

Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications

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

Stepwise Diagnosis of Trichomonas vaginalis Infection in Adolescent Women

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