Sensitivity and Specificity of Bacterial Vaginosis Rapid Test Kit in Diagnosing Bacterial Vaginosis: A Prospective Observational Study.

introductionBacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge among women of reproductive age and results from disruption of the normal vaginal microbiota. It is associated with adverse gynecological and obstetric outcomes, underscoring the need for early and accurate diagnosis. Conventional diagnostic methods require microscopy and laboratory expertise, limiting their applicability in resource-constrained settings. The present study aimed to evaluate the sensitivity and specificity of the BV rapid test kit, primarily based on vaginal pH detection, in diagnosing bacterial vaginosis among symptomatic women. MATERIALS AND

methodsThis prospective observational study was conducted over 18 months from June 2024 to December 2025 at Shri B.M. Patil Medical College Hospital and Research Centre, Vijayapura. A total of 285 married women aged 18-45 years presenting with complaints of vaginal discharge were included. Vaginal swabs were collected for the BV rapid test kit analysis and Papanicolaou (Pap) smear examination. Vaginal pH was measured using the test kit, and a pH value ≥4.6 was interpreted as suggestive of bacterial vaginosis according to the manufacturer's protocol. Pap smear findings were considered the reference standard for evaluating diagnostic performance. Sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy were calculated.

resultsOut of 285 married women, the mean age of the participants was 34.78 ± 6.66 years. Pap smear examination revealed infective pathology in 115 (40.4%) women, including bacterial vaginosis in 85 (29.8%) and candidiasis in 30 (10.5%). Elevated vaginal pH (≥4.6) was observed in 114 (40.0%) participants and demonstrated a statistically significant association with infective pathology (p < 0.001). The BV rapid test kit showed a sensitivity of 73.91% and a specificity of 82.94%. The positive predictive value and negative predictive value were 74.56% and 82.46%, respectively, with an overall diagnostic accuracy of 79.30%.

conclusionThe BV rapid test kit demonstrated moderate sensitivity and good specificity in detecting bacterial vaginosis among symptomatic women. Its rapid turnaround time, ease of use, and minimal infrastructure requirements make it a practical adjunct screening tool, particularly in settings where microscopy-based methods are not readily available. Incorporating point-of-care testing may facilitate timely treatment initiation and potentially reduce complications associated with untreated bacterial vaginosis.