双抗夹心三联检法诊断阴道炎的前瞻性多中心对照研究

A prospective,multicenter,controlled study of double antibody sandwich triplet method for detecting vaginitis

目的:评估双抗夹心法诊断外阴阴道假丝酵母菌病、细菌性阴道病、滴虫阴道炎的临床价值。方法:在我国8家医院共募集入组629例阴道炎患者,阴道分泌物双份取样,一份用双抗夹心法检测,一份用湿片镜检法和唾液酸酐酶法检测。根据临床症状、体征、实验室结果做出临床诊断。统计分析双抗夹心法及对照方法诊断外阴阴道假丝酵母菌病、细菌性阴道病、滴虫阴道炎的灵敏度、特异度、约登指数,分析它们之间的差异。结果:与对照方法相比,双抗夹心法诊断外阴阴道假丝酵母菌病、细菌性阴道病、滴虫阴道炎的特异度略低(93.3%vs 96.5%,90.8%vs 93.6%,95.8%vs 99.8%;P<0.001),但灵敏度和约登指数明显高于对照组(灵敏度:81.5%vs 54.9%,91.9%vs 37.7%,93.0%vs 40.3%;约登指数:0.75 vs 0.51,0.83 vs 0.31,0.89 vs 0.40;P<0.001);双抗夹心法在诊断混合感染方面的优势明显(灵敏度77.5%vs 30.0%,特异度89.3%vs 90.8%,约登指数0.66 vs 0.28;P<0.001)。结论:与传统的湿片镜检、酶法相比,双抗夹心三联检法的特异度略低,但检测灵敏度显著提高,更接近真实情况,且对混合感染的检测有一定优势。

Objective:To evaluate the clinical value of double antibody sandwich triplet method for detecting vulvovaginal candidiasis,bacterial vaginosis and trichomonal vaginitis.Methods:A total of 629 patients with vaginitis were recrutied in eight hospitals.Two pieces of vaginal discharge samples were collected.The one was detected by double antibody sandwich triplet method.The other one was detected for candidiasis and trichomonad using wet glass sheet by microscope,while bacterial vaginosis was measured by neuraminidase.According to the clinical symptoms and experimental results,we made clinical diagnosis.The sensitivity,specificity and Youden index of these different methods were analyzed.Results:Compared to the controlled methods,double antibody sandwich triplet method had lower specificity(vulvovaginal candidiasis 93.3%vs 96.5%,bacterial vaginosis 90.8%vs 93.6%,trichomonal vaginitis 95.8%vs 99.8%,P<0.001),but had higher sensitivity(vulvovaginal candidiasis 81.5%vs 54.9%,bacterial vaginosis 91.9%vs 37.7%,trichomonal vaginitis 93.0%vs 40.3%,P<0.001)and Youden index(vulvovaginal candidiasis 0.75 vs 0.51,bacterial vaginosis 0.83 vs 0.31,trichomonal vaginitis 0.89 vs 0.40,P<0.001).Double antibody sandwich triplet method had obvious advantages in detecting mixed infection(sensitivity 77.5%vs 30.0%,specificity 89.3%vs 90.8%,Youden index 0.66 vs 0.28,P<0.001).Conclusions:Compared with traditional wet glass sheet method and neuraminidase method,double antibody sandwich triplet method has obviously higher sensitivity and a litter lower specificity,which is closer to reality.Double antibody sandwich triplet method has some advantages in detecting mixed infection.