P2.002 Evaluation of a Real-Time PCR-Based Test For Bacterial Vaginosis

Background Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women. Since BV is associated with significant morbidity, accurate tools for diagnosing the disease are important. The Amsel criteria (AC) and Nugent score (NS) are currently used for BV diagnosis. Recently, a number of PCR-based tests providing objective, sensitive and specific BV detection have been described. This study aimed to evaluate a newly developed BV test based on quantitative detection of Gardnerella vaginalis, Atopobium vaginae, Lactobacillus spp. and total Bacteria using multiplex PCR. Methods PCR criteria were elaborated based on the relative counts of the targeted bacteria to classify vaginal microflora as BV, no BV or intermediate. Vaginal samples for the test evaluation were obtained from 274 patients addressing a gynaecologist for routine examination. All participants were of reproductive age, not pregnant and not menstruating at the time of enrollment. BV was diagnosed using the AC and NS. Results According to the NS results, 66 patients were BV positive, 156 were BV negative, and 52 were classified as intermediate. All patients positive by the NS were positive by the AC, and all patients negative by the NS were negative by the AC. Among 66 BV positive samples, 62 demonstrated PCR results corresponding to BV, and 4 samples were BV negative by PCR (94% sensitivity). Of the 156 negative samples, 151 were interpreted as BV negative using PCR criteria, and 5 samples - as BV positive (97% specificity). Conclusion A multiplex real-time PCR test for BV was developed showing 94% sensitivity and 97% specificity.