APTIMA^®Trichomonas vaginalis, a transcription-mediated amplification assay for detection of Trichomonas vaginalis in urogenital specimens

Abstract

The APTIMA^®Trichomonas vaginalis (APTIMA TV; Gen-Probe Inc.) assay is the only amplification-based assay for T. vaginalis (TV) currently cleared by the US FDA. The assay was cleared in April 2011. APTIMA TV utilizes target capture specimen processing, transcription-mediated amplification and chemiluminescent probe hybridization for the qualitative detection of TV ribosomal RNA. The assay is used for the screening/diagnosis of trichomoniasis in women. Specimen types that can be used include physician-collected endocervical swabs, vaginal swabs, endocervical specimens collected in PreservCyt^® (Thin Prep, Hologic Incorporated, MA, USA) solution and female urine specimens. The APTIMA TV assay has shown superior performance in side-by-side comparisons with other diagnostic methods in all patient populations and specimen types tested. Clinical sensitivity and specificity are >95 and 98%, respectively. The APTIMA TV assay fills a significant void in sexually transmitted infection diagnostics.

Keywords::

• APTIMA^®Trichomonas vaginalis assay
• diagnostic test
• nucleic acid amplification test
• sensitivity
• specificity
• transcription-mediated amplification
• Trichomonas vaginalis
• trichomoniasis
• vaginitis

Financial & competing interests disclosure

Kimberle Chapin has received honoraria and research funding from Gen-Probe and Becton Dickenson. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.