title: 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.
authors: Department of Pathology, Rhode Island Hospital, Providence, RI, USA. kchapin@lifespan.org
authors: Kimberle
authors: K
authors: Chapin
authors: Sarah
authors: S
authors: Andrea
mesh_terms: D005260:Female; D006801:Humans; D021141:Nucleic Acid Amplification Techniques; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012306:Risk; D012680:Sensitivity and Specificity; D014158:Transcription, Genetic; D014247:Trichomonas Vaginitis / Q000175:diagnosis*; D014246:Trichomonas vaginalis / Q000235:genetics / Q000302:isolation & purification*; D014481:United States; D014486:United States Food and Drug Administration; D014566:Urogenital System / Q000469:parasitology*
chemical_list: D011933:Reagent Kits, Diagnostic