Reliable and User-Friendly Self-Testing Performance Evaluation of Vaginal pH Rapid Test Panel (Vaginal Swab)

Abstract

The Vaginal pH Rapid Test Panel (Vaginal Swab) is a dry chemical-based in vitro diagnostic (IVD) device developed for semi-quantitative determination of vaginal pH using self-collected specimens. This study assessed its diagnostic performance using 220 vaginal secretion samples (200 normal and 20 abnormal) compared with a validated reference method. Results demonstrated high sensitivity (95.0%), specificity (99.0%), and overall accuracy (98.6%). The device showed strong resistance to interference when users adhered to pre-test guidelines, and intra-/inter-assay reproducibility exceeded 98%. These results confirm the test’s clinical reliability, usability, and cost-effectiveness as a self-testing tool for vaginal pH assessment and monitoring of vaginal microecological balance.