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

Abstract

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™ VPIII assay as a point-of-care test (POCT). The performance of the BD Affirm™ VPIII assay was compared with the BD Max™ 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™ VPIII assay showed a moderate sensitivity (79.8%) and a moderate specificity (80.3%) for diagnosing BV in all participants. The BD Affirm™ 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™ 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.