Comparison of the BD Affirm VPIII Test to Primary Care and Clinical Laboratory Methods for the Diagnosis of Bacterial Vaginosis and Yeast Vaginitis

Abstract

Background: Diagnosis of bacterial vaginosis (BV) or yeast vaginitis (YV) in the primary care physician's (PCP's) office has relied on patient symptoms, clinical findings during vaginal examination, and analysis of vaginal fluid. These approaches support PCP decisions when selecting patient treatment regimens for these conditions. Alternatively, vaginal specimens may be tested at a clinical or hospital-based laboratory where other diagnostic methods are used including the Nugent Gram stain (NGS), culture, or molecular methods. This study compared these methods and the BD Affirm VPIII (AFF) test to the diagnosis provided by the PCP. Methods: Eighty-four patients were enrolled at 3 primary care sites. Each site used routine Amsel criteria for BV and wet mount for YV. Three additional vaginal swabs were collected: the first was used to perform a NGS for BV; the second was used for yeast culture; and the third for testing with the AFF, a DNA probe-based method. Primary care physicians diagnosed and treated 36 patients for BV and 30 patients for YV. Results: Using a NGS score indicative of BV (>6), the sensitivity and specificity of Amsel criteria, AFF, and Nugent GS for BV was 95% and 57%, 100% and 71%, and 50% and 100%, respectively. For YV, the sensitivity and specificity of the wet mount, AFF, and yeast culture was 100% and 11%, 86% and 100%, and 100% and 100%, respectively. Several patients were misdiagnosed and treated inappropriately for BV and YV. Conclusions: The AFF outperformed and provided a faster result than traditional testing done in the PCP or clinical laboratory setting.