Additional Information

The Vaginitis Panel includes multiple in-vitro nucleic acid amplification tests that utilize real time transcription mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), multiple Candida species and Trichomonas vaginalis. The assas are intended to aid in the diagnosis of vaginitis on the automated Panther® system using the Aptima® Multitest Swab Kit only (orange label) clinician-collected and patient-collected (in a clinical setting) vaginal swab specimens from symptomatic females.

The assay reports a qualitative (negative/positive) result for BV, Candida and Trichomonas and does not report results for individual organisms. Differentiating between organisms does not affect treatment decisions, as guideline-recommended treatments are specific for BV rather than individual organisms. This is because BV is not caused by a single organism but instead due to an imbalance of the vaginal flora.

Testing for BV may be combined with Chlamydia, and/or Gonorrhea, testing for vaginal specimen source swab collected in the Aptima® Multitest Swab Specimen Collection Kit.

Performance of the assay has not been evaluated in individuals less than 14 years of age.
For a complete list of assay limitations we recommend that you review the manufacturers package inserts:

 https://www.hologic.com/package-inserts/diagnostic-products/aptima-bv-assay

https://www.hologic.com/package-inserts/diagnostic-products/aptima-cvtv-assay