Use

The assay is intended to aid in the diagnosis of bacterial vaginosis (BV), and Chlamydia trachomatis/Neisseria gonorrhoeae using clinician‑collected and patient‑collected vaginal swab specimens from individuals with a clinical presentation consistent with vaginitis and/or vaginosis. The BV component is an in vitro nucleic acid amplification test utilizing real‑time transcription‑mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with BV, including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae; it reports a qualitative result for BV and does not report individual organisms. For Chlamydia trachomatis and Neisseria gonorrhoeae, a target capture assay is used for qualitative detection and differentiation of rRNA from these organisms.