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

Expert Rev Mol Diagn. 2011 Sep;11(7):679-88. doi: 10.1586/erm.11.53.

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.

Publication types

  • Review

MeSH terms

  • Female
  • Humans
  • Nucleic Acid Amplification Techniques*
  • Reagent Kits, Diagnostic*
  • Reproducibility of Results
  • Risk
  • Sensitivity and Specificity
  • Transcription, Genetic*
  • Trichomonas Vaginitis / diagnosis*
  • Trichomonas vaginalis / genetics
  • Trichomonas vaginalis / isolation & purification*
  • Vereinigte Staaten
  • United States Food and Drug Administration
  • Urogenital System / parasitology*

Substances

  • Reagent Kits, Diagnostic