Molecular testing for Trichomonas vaginalis in women: Results from a prospective U.S. clinical trial

Jane R. Schwebke, Marcia M. Hobbs, Stephanie N. Taylor, Arlene C. Sena, Michael G. Catania, Barbara S. Weinbaum, Ann D. Johnson, Damon K. Getman, Charlotte A Gaydos

Research output: Contribution to journalArticle

Abstract

Trichomoniasis is a common sexually transmitted disease associated with preterm birth, low birth weight, and increased susceptibility to infection with other pathogenic sexually transmitted microorganisms. Nucleic acid amplification tests for Trichomonas vaginalis have improved sensitivity for detecting infected individuals compared to existing culture-based methods. This prospective, multicenter U.S. clinical trial evaluated the performance of the automated Aptima T. vaginalis assay for detecting T. vaginalis in 1,025 asymptomatic and symptomatic women. Vaginal swab, endocervical swab, ThinPrep PreservCyt, and urine specimens were collected. Subject infection status was determined by wet-mount microscopy and culture. Aptima T. vaginalis assay performance was determined for each specimen type by comparison to subject infection status. Of 933 subjects analyzed, 59.9% were symptomatic. Aptima T. vaginalis clinical sensitivity and specificity were, respectively, 100% and 99.0% for vaginal swabs, 100% and 99.4% for endocervical swabs, 100% and 99.6% in ThinPrep samples, and 95.2% and 98.9% in urine specimens. Aptima T. vaginalis performance levels were similar in asymptomatic and symptomatic subjects. This study validates the clinical performance of the Aptima T. vaginalis assay for screening asymptomatic and symptomatic women for T. vaginalis infection.

Original languageEnglish (US)
Pages (from-to)4106-4111
Number of pages6
JournalJournal of Clinical Microbiology
Volume49
Issue number12
DOIs
StatePublished - Dec 2011

Fingerprint

Trichomonas vaginalis
Clinical Trials
Infection
Trichomonas Infections
Nucleic Acid Amplification Techniques
Urine
Premature Birth
Low Birth Weight Infant
Sexually Transmitted Diseases
Microscopy
Sensitivity and Specificity

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Molecular testing for Trichomonas vaginalis in women : Results from a prospective U.S. clinical trial. / Schwebke, Jane R.; Hobbs, Marcia M.; Taylor, Stephanie N.; Sena, Arlene C.; Catania, Michael G.; Weinbaum, Barbara S.; Johnson, Ann D.; Getman, Damon K.; Gaydos, Charlotte A.

In: Journal of Clinical Microbiology, Vol. 49, No. 12, 12.2011, p. 4106-4111.

Research output: Contribution to journalArticle

Schwebke, JR, Hobbs, MM, Taylor, SN, Sena, AC, Catania, MG, Weinbaum, BS, Johnson, AD, Getman, DK & Gaydos, CA 2011, 'Molecular testing for Trichomonas vaginalis in women: Results from a prospective U.S. clinical trial', Journal of Clinical Microbiology, vol. 49, no. 12, pp. 4106-4111. https://doi.org/10.1128/JCM.01291-11
Schwebke, Jane R. ; Hobbs, Marcia M. ; Taylor, Stephanie N. ; Sena, Arlene C. ; Catania, Michael G. ; Weinbaum, Barbara S. ; Johnson, Ann D. ; Getman, Damon K. ; Gaydos, Charlotte A. / Molecular testing for Trichomonas vaginalis in women : Results from a prospective U.S. clinical trial. In: Journal of Clinical Microbiology. 2011 ; Vol. 49, No. 12. pp. 4106-4111.
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