BV Rapid Blue demonstrates high sensitivity and NPV for bacterial vaginosis screening in pregnancy
The study reports a cross-sectional diagnostic accuracy evaluation of the BV Rapid Blue point-of-care test against Amsel criteria in 131 pregnant women at a regional hospital in Indonesia. Investigators found the assay achieved a sensitivity of 95.4% and a negative predictive value of 96.1%, with strong overall agreement to the clinical reference standard (p < 0.0001), while bacterial vaginosis prevalence reached 61.1%. The high sensitivity and negative predictive value position BV Rapid Blue as a reliable screening tool that could streamline early diagnosis and clinical management in resource-limited settings where centralized laboratory capacity is constrained.
The original study
Association between bacterial vaginosis prevalence and maternal characteristics in pregnant women: Diagnostic comparison of BV Rapid Blue and Amsel's criteria.
- Authors
- Hermawan H, Santoso DPJ, Nugrahani AD, Aziz MA
- Journal
- PloS one
- Type
- Journal Article, Comparative Study
- PMID
- 42599945
Original abstract
BACKGROUND: Bacterial vaginosis (BV) is a common vaginal infection associated with adverse pregnancy outcomes and increased susceptibility to sexually transmitted infections. This study evaluated the diagnostic performance of the BV Rapid Blue point-of-care test compared with Amsel's criteria and assessed maternal characteristics and pregnancy outcomes among BV-positive pregnant women at Dr. Slamet Regional Hospital, Garut. METHOD: A cross-sectional diagnostic accuracy study was conducted among 131 pregnant women between April and May 2025. The diagnostic performance of BV Rapid Blue was evaluated using Amsel's criteria as the pragmatic clinical reference standard. Diagnostic accuracy parameters were calculated, and multivariate logistic regression was performed to identify factors associated with BV. RESULTS: BV prevalence was 61.1%. Most participants were aged 25-35, multigravida, and had high school education. All participants reported vaginal discharge, while only 3.1% reported a history of STIs. Common complications included preeclampsia (46.6%) and PROM (32.1%). BV Rapid Blue showed strong agreement with Amsel's criteria (p < 0.0001), with sensitivity 95.4%, specificity 55.7%, PPV 51.3%, and NPV 96.1%. BV recurrence (OR = 4.29, p < 0.0001) and secondary infection (OR = 2.56, p = 0.01) were significant predictors, while higher education was protective (OR = 0.52, p = 0.02). CONCLUSIONS: BV remains prevalent in pregnancy. BV Rapid Blue is a reliable, rapid diagnostic tool with high sensitivity and NPV. Early diagnosis may facilitate earlier clinical assessment and management, particularly in settings where laboratory-based diagnostics are limited.