Diagnostic evaluation of the BD Affirm VPIII assay as a point-of-care test for the diagnosis of bacterial vaginosis, trichomoniasis and candidiasis

Untreated sexually transmitted infections and bacterial vaginosis (BV) pose a serious health risk to mother and child. Limited data exist on the use of the BD Affirm (TM) VPIII assay as a point-of-care test (POCT). The performance of the BD Affirm (TM) VPIII assay was compared with the BD Max (TM) vaginal assay for the diagnosis of BV, Trichomonas vaginalis (TV) and Candida spp. A total of 273 pregnant women were enrolled in this study and had provided two self-collected vaginal swabs. Sensitivity, specificity, positive predictive value, negative predictive value and prevalence were calculated. The prevalence of BV, candidiasis and trichomoniasis was 49.4, 57.2 and 10.3%, respectively. The BD Affirm (TM) VPIII assay showed a moderate sensitivity (79.8%) and a moderate specificity (80.3%) for diagnosing BV in all participants. The BD Affirm (TM) VPIII assay had an excellent specificity for Candida spp. and TV of 97.4 and 100%, respectively; however, the assay exhibited poor sensitivities of 52.9 and 46.4%, respectively. This study was the first to report on the performance of the BD Affirm (TM) VPIII assay as a POCT in an antenatal population. The assay was found to be unsuitable as a screening test for vaginal infections in pregnancy.