Journal of Clinical Microbiology
Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and acquisition/transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA-cleared in the United States for detection of Trichomonas vaginalis (TV) in specimens from both women and men. This current study reports the results of a multicenter study recently conducted using the Xpert TV Assay to test specimens from both men and women. On-demand results were available in as little as 40 minutes for positive specimens. A total of 1867 women and 4791 men were eligible for inclusion in the analysis. In women, the performance of the Xpert TV Assay was compared to a patient infected status (PIS) derived from results of InPouch TV broth culture and Aptima NAAT for TV. Diagnostic sensitivity and specificity of the Xpert TV Assay for the combined female specimens (urines, self-collected vaginal swabs, and endocervical swabs) ranged from 99.5 - 100% and 99.4 - 99.9%, respectively. For male urines, diagnostic sensitivity and specificity was 97.2% and 99.9% respectively, compared to a PIS derived from results of broth culture for TV and bi-directional gene sequencing of the amplicons. Excellent performance characteristics were seen using both female and male specimens. The ease of using the Xpert TV Assay should result in opportunities for enhanced screening for TV in both men and women and hopefully improved control of this infection.
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Schwebke, J., Gaydos, C., Davis, T., Marrazzo, J., Furgerson, D., Taylor, S., Smith, B., Bachmann, L., Ackerman, R., Spurrell, T., Ferris, D., Burnham, C., Reno, H., Lebed, J., Eisenberg, D., Kerndt, P., Philip, S., Jordan, J., & Quigley, N. (2017). Clinical Evaluation of the Cepheid Xpert® TV Assay for Detection of Trichomonas Vaginalis with Prospectively Collected Female and Male Specimens.. Journal of Clinical Microbiology, (). http://dx.doi.org/10.1128/JCM.01091-17