Title:Comparison of the BD Max™ vaginal panel, against standard methods, for the detection of common vaginitis conditions.

Author:Julie A Creighton and Bethany J Mills

Abstract:Objectives: Bacterial vaginosis, vulvovaginal candidiasis and Trichomonas vaginalis infections are common causes of vaginitis and vaginal discharge conditions that frequently affect women, particularly d uring r eproductive years. T he a im of this study was to compare the performance of the BD MAX™ Vaginal Panel (MAX VP), a qualitative molecular test against routine laboratory procedures for the detection of these conditions. The primary focus was for the detection of bacterial vaginosis as Gram stain assessment is a particularly challenging area for microbiology laboratories, due to subjective interpretation.
Methods: Vaginal swabs, collected in Amies transport medium from 96 females, between November to December 2022, were included in the study. Routine methods including Gram stain and culture were performed before the swabs were transferred into AlinityM UVE Sample Buffer Tubes for PCR analysis with the BD MAX™ Vaginal Panel, using the BD MAX system.
Results: The performance of BD MAX™ Vaginal Panel was assessed in comparison to routine diagnostic tests. Overall, BD MAX™ Vaginal Panel performed with high sensitivity and specificity. For the diagnosis of bacterial vaginosis (BV), BD Max™ Vaginal Panel achieved a sensitivity of 94.1% and specificity of 95.2%; f or the diagnosis of candidiasis, 9 6.0% a nd 9 7.2% respectively; a nd for diagnosis of T. vaginalis a sensitivity of 100% and specificity could not be calculated.
Conclusion: The results of our study demonstrated that the BD MAX™ Vaginal Panel provided high sensitivity and specificity for the diagnosis BV, candidiasis and T. vaginalis and correlated well with Gram stain interpretation. The overall results of our study are in line with other evaluations of BD MAX™ Vaginal Panel. We suggest that BD MAX™ Vaginal Panel would be a useful adjunct to Gram stain testing when the Gram is inconclusive or indeterminate.
Keywords: Bacterial vaginosis, Vulvovaginal candidiasis, Trichomonas vaginalis, molecular test, BD MAX™ Vaginal Panel.
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