淋球菌/沙眼衣原体抗原二联检测试剂盒在检测女性宫颈分泌物中的应用评价

摘要

Objective:To explore the clinical application of gonorrhea/chlamydia trachomatis antigen two combined detection kit(latex immunochromatographic assay) (hereinafter referred to as gonococcal/chlamydia two joint detection reagent) in the detection of female cervical secretions.Methods:558 cases with suspected gonorrhea/chlamydia trachomatis infected females were selected.We detected the cervical secretion.The gold standard of neisseria gonorrhoeae was culture method.The control of chlamydia trachomatis was Hangzhou ACON chlamydia trachomatis immunochromatographic reagent.Discrepant samples were confirmed by PCR.We evaluated the clinical performance of gonococcal/chlamydia two joint detection reagent.Results:The sensitivity of gonococcal/chlamydia two joint detection reagent in the detection of neisseria gonorrhoeae and chlamydia trachomatis was 96.88% and 94.12% respectively.Specificity was 95.75% and 99.15% respectively.Accuracy was 95.88% and 98.39% respectively.Conclusion:Operation of gonococcal/chlamydia two joint detection reagent is simple and fast.It has the advantages of high specificity, sensitivity and effectiveness.So it is suitable for the pregnancy test in grassroots station and census application in the maternal and child health hospital.%目的：探讨淋球菌/沙眼衣原体抗原二联检测试剂盒(乳胶免疫层析法)(以下简称淋球菌/衣原体二联检测试剂)检测女性宫颈分泌物中淋球菌/沙眼衣原体的临床应用。方法：收治疑为淋球菌/沙眼衣原体女性感染者558例，对其宫颈分泌物标本进行检测。淋球菌以培养法为金标准，沙眼衣原体以杭州艾康沙眼衣原体免疫层析试剂为对照，不符的标本用PCR确认，进行评价淋球菌/衣原体二联检测试剂的临床性能。结果：淋球菌/衣原体二联检测试剂检测淋球菌和沙眼衣原体的敏感性分别为96.88%和94.12%，特异性分别为95.75%和99.15%，准确性分别为95.88%和98.39%。结论：淋球菌/衣原体二联检测试剂操作简单、快速、具有较高的特异性、敏感性和有效性，适宜基层计生站孕前检测和妇保院普查应用。