SureSwab® Advanced Bacterial Vaginosis (BV), TMA

This Food and Drug Administration (FDA)-cleared, transcription-mediated amplification (TMA)-based test is intended to aid in the diagnosis of BV using clinician-collected or patient-collected vaginal swab specimens (in a clinical setting) from individuals with a clinical presentation consistent with vaginitis and/or vaginosis.

The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real-time 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. The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV on the automated Panther® system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.¹

The SureSwab Advanced Bacterial Vaginosis (BV), TMA assay utilizes a different technology (ie, real-time TMA) to detect and quantify bacteria associated with BV. Results from the TMA assay are applied to a proprietary algorithm and reported as a clear, qualitative “positive” or qualitative “negative” for BV. Unlike the PCR-based test, this assay is FDA-cleared and does not report results for individual organisms.

No, test results for individual organisms are not listed on the patient report and are not available. Results are reported as positive or negative for BV. Differentiating between the organisms does not affect treatment decisions, as guideline-recommended treatments are specific for BV rather than individual organisms.² This is because BV is not caused by a single organism but is instead due to an imbalance of the vaginal flora.