Wondfo沙眼衣原体免疫层析法试剂盒临床应用评价  

Evaluation of Wondfo Rapid Diagnostic Cassette for Chlamydia Trachomatis

作　　者：彭运平[1] 李文美[1,2] 郑和平[3] 王群[4] 陈万山[5] 李辉 王继华 杨永崧 

机构地区：[1]华南理工大学轻工食品学院,广州510641 [2]广州万孚生物技术有限公司,广州510641 [3]广东省皮肤性病防治中心,广州510550 [4]广东省人民医院,广州510080 [5]广州市第八人民医院,广州510610

出　　处：《皮肤性病诊疗学杂志》2011年第1期22-25,共4页Journal of Diagnosis and Therapy on Dermato-venereology

摘　　要：目的:评价wondfo沙眼衣原体免疫层析法试剂盒灵敏度、特异性和用于泌尿生殖道沙眼衣原体检测的意义。方法:采用与已上市同类产品ClearView试剂盒同步盲法检测泌尿生殖道沙眼衣原体抗原,两法结果不一致时采用直接免疫荧光法DFA确证。以两种试剂盒均阳性或经DFA确证阳性的结果作为真阳性,计算wondfo试剂盒的灵敏度、特异性、阳性预测值和阴性预测值。结果:共检测1026例样本(630份女性宫颈拭子和396份男性尿道拭子),真阳性92例,真阴性934例。wondfo和Clear-View检测结果均阳性83例,均为阴性930例,13例结果不符的样本经DFA复检9例为阳性,其中3例ClearView结果阳性wondfo结果阴性的样本DFA复检为阳性;10例ClearView结果为阴性wondfo结果为阳性的样本DFA复检6例为阳性。两试剂盒检测结果符合率为98.64%。Wondfo试剂盒灵敏度、特异性、阳性预测值和阴性预测值分别为96.74%,99.6%,95.7%,99.68%。对3株标准株及2株临床株倍比稀释检测,wondfo试剂盒的最低检出量约为25～50 IFU/μL。结论:wondfo沙眼衣原体层析法检测试剂盒检测CT有较高的敏感性和特异性,可为临床治疗和性病监测工作提供可靠依据。Objective：To evaluate the sensitivity and specificity of Wondfo Chlamydia trachomatis Rapid diagnostic Cassette. Methods：1026 genital specimens were collected from 630 females and 396 males.Two cassettes of Wondfo and ClearView were eveluated for the detection of Chlamydia trachomatis samples with blind detection simultaneously,and confirmed by DFA when inconsistent results of these two tests exist.Sensitivity,specificity,positive predictive value and negative predictive value of wondfo cassette were analyzed. Results：Out of 1026 samples detected,83 samples were positive by both Wondfo and ClearView,13 samples showed different results by Wondfo and ClearView.Out of the 13 samples,the DFA（direct fluorescent antibody） test confirmed 9 were positive.Therefore,92 samples were truly positive and 934 were truly negative.The sensitivity,specificity,positive predictive value and negative predictive value of Wondfo were 96.74%,99.6%,95.7%,99.68%.respectively.Wondfo and ClearView tests achieved same results in 98.64% of samples.Results from dilution test of three standard strains and two clinical strains showed that the lowest detectable range of Wondfo was 25~50 IFU/μL. Conclusion：The sensitivity and specificity of Wondfo for the detection of Chlamydia trachomatis is acceptable to use in clinical diagnosis and surveillance.

关 键 词：沙眼衣原体 免疫层析法 直接免疫荧光法 

分 类 号：R759[医药卫生—皮肤病学与性病学]