乳胶免疫层析法检测阴道炎三种病原的临床应用评价

Evaluation and Clinical Application of Latex Immunochromatography in the Detection of Three Pathogens of Vaginitis

目的评估乳胶免疫层析法联合检测阴道炎三种病原的诊断效果并对其临床应用进行评价。方法收集2019年1~12月在妇科门诊接受阴道分泌物检查的288例标本,分别用乳胶免疫层析法、湿片镜检法、唾液酸苷酶法以及革兰氏染色镜检法检测。根据临床症状、体征、实验室结果做出临床诊断。记录乳胶免疫层析法与湿片镜检法、染色镜检法诊断阴道炎三种病原的敏感度、特异度、Kappa系数和约登指数,并进行统计分析。结果与湿片镜检法相比,乳胶免疫层析法诊断阴道炎三种病原的敏感度、Kappa系数和约登指数较高,差异有统计学意义(χ^2=6.11~30.13,P=0.01~0.04);与染色镜检法相比,乳胶免疫层析法对诊断细菌性阴道病、外阴阴道假丝酵母菌病的敏感度、约登指数较高,诊断细菌性阴道病的Kappa系数也较高,差异均有统计学意义(χ^2=2.66~30.13,P均<0.05);乳胶免疫层析法在诊断混合感染方面具备明显优势,对细菌性阴道病、外阴阴道假丝酵母菌、滴虫性阴道炎的检测特异度均达到90%以上,敏感度、Kappa系数及约登指数均高于湿片镜检法和染色镜检法,差异均有统计学意义(χ^2=4.66~9.12,均P<0.05)。结论与传统的湿片镜检法和染色镜检法相比,乳胶免疫层析法对于阴道炎三种病原的检测敏感度高,与临床诊断结果的一致性高,且对混合感染的检测有明显优势。

Objective To evaluate the efficacy and clinical application of latex immunochromatography in the detection of three pathogens of vaginitis,namely bacterial vaginosis,Candida vulvovaginal and trichomonal vaginitis.Methods 288 cases of vaginal secretions from January to December 2019 were collected and examined by latex immunochromatography,wet film microscopy(group l),and Gram staining microscopy(group 2).Clinical diagnosis was made according to the clinical symptoms,signs and laboratory results.The sensitivity,specificity,Kappa coefficient and Joden index of three pathogens in vaginitis were recorded and statistically analyzed.Results Compared with the wet film microscopy group,the sensitivity,Kappa coefficient and Joden index of the bacterial vaginosis and Candida vulvovaginal of vaginitis were higher significantly in the latex immunochromatography group(χ^2=6.11~30.13,P=0.01~0.04).Compared with Gram staining microscopy group,the sensitivity and Joden index of the three pathogens were higher in the latex immunochromatography group,the Kappa coefficient of bacterial vaginosis diagnosis was higher than that of Gram staining microscopy group,the difference was statistically significant(χ^2=2.66~30.13,all P<0.05).Besides,the latex immunochromatography combined detection had significant advantages in the diagnosis of mixed infection with a high specificity over 90%.The sensitivity,Kappa coefficient and Jordan index were higher significantly than that of wet film microscopy group and Gram staining microscopy group,and the difference was statistically significant(χ^2=4.66~9.12,all P<0.05).Conclusion Compared with the traditional wet film microscopy and Gram staining microscopy,latex immunochromatography was more sensitive to the detection of three vaginitis pathogens with a high specificity and higher consistence with the clinical diagnosis results,and had obvious advantages in the detection of mixed infection.