Geva Adam, Bornstein Jacob, Dan Michael, Shoham Hadar Kessary, Sobel Jack D
SBC Women's Health Centers of Lin, Israel.
Am J Obstet Gynecol. 2006 Nov;195(5):1351-6. doi: 10.1016/j.ajog.2006.04.008. Epub 2006 Jun 12.
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.
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.
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.
The VI-SENSE test was found to be superior to traditional individual tests in facilitating preliminary diagnosis of vaginal infections.
本研究旨在评估一种诊断性卫生护垫(VI-SENSE)(以色列凯撒利亚的常识公司),该护垫通过检测酸度水平紊乱来辅助诊断阴道感染。
招募了516名有外阴阴道症状的女性。最终临床诊断包括阿姆斯勒标准、革兰氏染色分析、pH值测定以及阴道毛滴虫和念珠菌培养。将患者估计的VI-SENSE试纸颜色状态与临床诊断以及使用硝嗪纸进行的pH值测量进行比较。统计分析包括敏感性和特异性计算。
在249例患有细菌性阴道病或滴虫病的患者中,226例(90.8%)的VI-SENSE检测呈阳性。硝嗪pH试纸显示165例(66.5%)pH值升高,胺试验在160例(64.3%)患者中呈阳性。在267例无滴虫病或细菌性阴道病的患者中,217例(81.3%)的VI-SENSE检测呈阴性。在92例患有包括念珠菌与细菌性阴道病或滴虫病混合感染的女性中,85例(92%)的VI-SENSE检测呈阳性。胺试验、硝嗪pH试纸以及仅依靠窥器检查的医生诊断效果较差,分别仅在65例(70%)、59例(64%)和66例(72%)患者中呈阳性。
发现VI-SENSE检测在辅助阴道感染的初步诊断方面优于传统的单项检测。