干化学酶法检测淋病的临床评价及室问质评结果分析  

Clinical evaluation of dry chemical enzyme method for detecting Neisseria gonorrhoeae and analysisof external quality assessment results

作　　者：王英芳 泰淑红[2] 杨红云 Wang Yinffang;Tai Shuhong;Yang Hongyun(Department of Cynaecology and Obstetrics,Henan Province People＇s Hospital,Zhengzhou 450003,China)

机构地区：[1]河南省人民医院妇科郑州大学人民医院妇科,郑州450003 [2]河南省妇幼保健院郑州大学第三附属医院检验科,郑州450003 [3]郑州大学生命科学学院,郑州450003

出　　处：《中华医学杂志》2018年第33期2671-2674,共4页National Medical Journal of China

摘　　要：目的使用干化学酶法和培养法检测女性宫颈样本中淋病奈瑟菌，分析2种检测方法检测效果，为临床快速检测淋病奈瑟菌提供一种新的方法。同时对淋球菌分离鉴定室间质评菌株进行鉴定，评定该方法学的可靠性。方法2015年10月至2017年12月期间，收集河南省妇幼保健院郑州大学第三附属医院和河南省人民医院检验科宫颈分泌物样本8860例，分别用干化学酶法和培养法对样本进行检测，对差异结果采用PCR-荧光探针法进行补充检测，评价这两种检测方法的临床应用价值。对2015至2017年中国疾病预防控制中心提供的淋球菌分离鉴定室间质量评价15株菌株进行鉴定，采用乳胶免疫层析法，培养法，干化学酶法以及PCR一荧光探针法等方法进行对比试验。结果干化学酶法试剂阳性率为0．88％（78／8860）；培养法阳性率为0．41％（36／8860），其中有26份样本干化学酶法检测为阳性，平板培养为阴性，PCR为阳性。干化学酶法检测阳性率与培养法相比差异有统计学意义（P〈0．05），检测灵敏度为97．2％，特异度为99．5％，总符合率为99．5％。干化学酶法3年室问质量评价结果准确。结论干化学酶法试剂有较高的特异性，且灵敏度较高，室间质评结果准确可靠，检测临床符合率高于培养法，可作为临床筛查淋病的辅助手段。Objective Neisseria gonorrhoeae in female cervix sample was detected by dry chemical enzymatic method and culture method. The detection effects of two detection methods were analyzed to provide reference for clinical detection. At the same time, strains were separated and identified to evaluate reliability of different methods. Methods During October 2015 to December 2017, 8 860 samples of female cervix from the Third Affiliated Hospital of Zhengzhou University and Henan Provincial Peoples Hospital were detected by dry chemical enzymatic method and culture method. Because of the possible leak detection by culture method, the inconsistent results were supplemented by real-time PCR assay. The data were analyzed by SPSS 19.0. Fifteen strains of external quality assessment of Neisseria gonorrhoeae identification and validation during 2015 to 2017 years were identified by latex chromatography, culture method, dry chemical enzyme method and PCR- fluorescent probe method. Results The positive rates of dry chemical enzymatic method and culture method for detection of Neisseria gonorrhoeae were O. 88% （78/8 860） and 0.41% （ 36/8 860）, respectively. Among these, 26 samples were tested positive by dry chemical enzymatic method which were consistent with real-time PCR assay. Meanwhile, the culture method was negative. Dry chemistry enzyme method external quality assessment results of 3 years were accurate. Conclusion The positive rate of dry chemical enzymatic method was markedly higher than that of culture method （P 〈 0.05）. The dry chemical enzymatic method, while exhibiting a high specificity, had high detection rate compared to culture method. And external quality assessment results are accurate. The clinical coincidence rate of dry chemical enzymatic detection was higher.

关 键 词：淋病奈瑟菌 干化学酶法 临床评价 

分 类 号：R759.2[医药卫生—皮肤病学与性病学]