Validity evaluation of in-house preparation kit, vaginal pH paper test combined amine tube test, for the simple diagnosis of bacterial vaginosis

摘要

Objective: Determine the positive in-house preparation kit for suggested bacterial vaginosis (BV) for both elevated vaginal pH > 4.5 and positive amine test, as well as evaluate for validity of sensitivity, specificity, positive predictive value, and negative predictive value against Chandeying criteria for confirmed BV. Material and Method: A cross-sectional study among the women who presented with an abnormal vaginal discharge (AVD) or asymptomatic annual cervical cytology screening was done. Each vaginal discharge was divided into two parts of investigation. The first part included the clinical criteria of confirmed BV, based on at least three out of five indicators, the vaginal pH > 4.5, homogeneous and thin discharge (milky discharge), positive sniff/amine test, clue cell > 20% of total vaginal epithelial cells, and scanty or absence lactobacilli. The second part included the in-house preparation kit of suggestive BV, relied on elevated vaginal pH > 4.5 and positive amine tube test. Results: Twenty-six women were enrolled. Of the complaint of AVD/asymptomatic had 2/10 of confirmed BV (12 cases), and 1/13 of confirmed non-BV (14 cases). The in-house preparation kit, compared with the clinical criteria, had sensitivity of 91%, specificity of 71%, positive predictive value of 73%, and negative predictive value of 90%. There were false negative of 1/12 cases (8.3%), and false positive of 4/14 cases (28.5%). Conclusion: The in-house preparation kit favorably compared with the clinical criteria and has the advantage of being simple, rapid, and easily performed in resource poor setting. Further development on sensitivity and specificity of the test is suggested.