Diagnostic value point of care lateral flow immunochromatographic assay in bacterial vaginosis: A pilot study.

BackgroundBacterial vaginosis (BV) is a vaginal dysbiosis with a global prevalence range from 20 to 60%. The gold standard for diagnosis BV is the Nugent score, while clinical diagnosis uses Amsel criteria; both have limitations such as prolonged examination time, requiring a microscope, and trained healthcare personnel. Point-of-care lateral flow immunochromatographic assay (POCT-LFIA) is an alternative method for diagnosing BV.MethodsWe conducted a pilot diagnostic study among women with vaginal discharge at the Sexually Transmitted Infections (STI) Clinic at RSMH Palembang from February to April 2026. All study subjects suspected of having BV with vaginal discharge characteristics underwent POCT-LFIA, vaginal pH, whiff test, and Gram stain examinations to detect clue cells and calculate the Nugent score. A definitive diagnosis of BV was established based on a Nugent score of 7-10.ResultsAmong of 77 participants, 36 (47%) were diagnosed with BV based on Nugent score. POCT-LFIA was positive in 33 of 36 these cases, with three false-negative results, and three false-positive results occurred among the 41 participants without BV. Whereas Amsel criteria identified 32 cases. The POCT-LFIA had 92% sensitivity, 93% specificity, 92% positive predictive value, 93% negative predictive value, and 92% diagnostic accuracy. The corresponding values for the Amsel criteria were 89%, 90%, 91%, 90%, and 91%, respectively. The POCT-LFIA was comparable with Amsel criteria to diagnose BV.ConclusionsPOCT-LFIA demonstrated promising diagnostic performance for BV with results comparable to the Amsel criteria. Larger, multicentre studies are needed to validate these findings and determine its clinical applicability.