Multiple infectious organism IVDs

Intended purpose

The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vaginitis, trichomoniasis, and vulvovaginitis. The assay utilizes real time transcription-mediated amplification (TMA) to detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Trichomonas vaginalis. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated Panther® system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis, trichomoniasis, and/or vulvovaginitis.