P366 An evaluation of the BD MAX™ vaginal panel compared to the nugent score for diagnosis of bacterial vaginosis (BV). (14th July 2019) - Cosentino, Lisa
Abstract : Background: The Nugent criteria have been used as a comparator to Amsel criteria for diagnosis of BV. The BD MAX™ Vaginal Panel (MVP) received market authorization by the FDA as a molecular test to aid in the diagnosis of vaginitis/vaginosis. The assay detects Lactobacillus crispatus, L. jensenii, Gardnerella vaginalis, Atopobium vaginae, Megasphaera -1 and BVAB-2, utilizing a semi-quantitative algorithm. Our objective was to evaluate agreement between Nugent score (NS) and MVP and to identify factors contributing to the discordance between methods. Methods: 303 women aged 18–40 presenting with a complaint of vaginitis symptoms provided informed consent and were enrolled at 8 community practice sites affiliated with a single medical system. Clinicians evaluated study participants per local practice and 5 additional vaginal swabs were collected. Vaginal swabs were evaluated by the MVP, plus NS (≥6) for diagnosis of BV. Quantitative PCR (qPCR) was used to evaluate vaginal microbiota in the samples yielding discordant results. Results: Of the 290 evaluable samples, the level of agreement between NS and MVP was 88% with 36 discordant results. There were 6 Nugent 0–3 and 13 NS 4–6 that were BV positive by MVP. Of these 19, the median concentration of L. iners by qPCR was log concentration 7.3, A. vaginae was 6.7 and G. vaginalis was 7.5. Of the 17 positive for BV by NS (median NS 8) but negative by MVP, the median concentration of G. vaginalis was 7.5 but A. vaginae and L. crispatus had medians of 0 by qPCR. Conclusion: Nugent score and MVP had high levels of agreement for diagnosis of BV. Because L. iners is indistinguishable from L. crispatus and L. jensenii by Gram stain, high concentrations of this microorganism contribute to lower NS and substantially contributes to the NS-/MVP+ discordance. The primary source of discordance for NS+/MVP- samples is lack of A. vaginae. Disclosure: No significant relationships.