The VI-SENSE-vaginal discharge self-test to facilitate management of vaginal symptoms

Objective: This study was undertaken to evaluate a diagnostic panty liner (VI-SENSE) (Common Sense, Caesarea, Israel) developed to facilitate diagnosis of vaginal infections by detecting disordered acidity level. Study design: Five hundred sixteen women with vulvovaginal symptoms were enrolled. Final clinical diagnosis included Amsel criteria, Gram stain analysis, pH determination, and Trichomonas vaginalis and Candida culture. VI-SENSE strip color status estimated by patients was compared with clinical diagnosis and pH measurement by using nitrazine paper. Statistical analysis included sensitivity and specificity calculations. Results: The VI-SENSE test was positive in 226 of 249 patients (90.8%) with bacterial vaginosis or trichomoniasis. Nitrazine pH paper revealed elevated pH in 165 (66.5%) and the amine test was positive in 160 (64.3%) patients. The VI-SENSE test was negative in 217 of 267 patients (81.3%) without trichomoniasis or bacterial vaginosis. The VI-SENSE was positive in 85 of 92 women (92%), with mixed vaginal infection including Candida and bacterial vaginosis or trichomoniasis. Amine test, nitrazine pH paper and physician diagnosis relying only on speculum examination were inferior and positive in only 65 (70%), 59 (64%), and 66 (72%) patients, respectively. Conclusion: The VI-SENSE test was found to be superior to traditional individual tests in facilitating preliminary diagnosis of vaginal infections.