3种甲型肝炎病毒IgM抗体检测试剂盒的灵敏度及特异度评价  

Evaluation of sensitivity and specificity of three reagents for detection of hepatitis A virus IgM antibody

作　　者：李春艳 孙会芳 张晓果 陈安邦 董瑞静 LI Chunyan;SUN Huifang;ZHANG Xiaoguo;CHEN Anbang;DONG Ruijing(Zhengzhou Auto Bioengineering Co.,Ltd.,Zhengzhou,Henan 450016,China)

机构地区：[1]郑州安图生物工程股份有限公司,河南郑州450016

出　　处：《检验医学与临床》2020年第S01期29-31,共3页Laboratory Medicine and Clinic

摘　　要：目的对国内市场上应用较广的3种甲型肝炎病毒抗体(HAV-IgM)检测试剂进行灵敏度及特异度评价。方法购买Seracare(BBI)的血清盘PHT202及PHT903,以R公司的HAV-IgM试剂检测结果作为标准,A为参比,评价郑州安图生物工程股份有限公司及W公司和K公司3种检测HAV-IgM试剂的灵敏度及特异度。收集市场上的临床标本,以R公司的HAV-IgM试剂检测结果作为标准,A为参比,评估郑州安图生物工程股份有限公司及W公司和K公司3种检测HAV-IgM试剂的灵敏度及特异度。结果3个厂家检测两个血清盘及收集市场上的临床标本灵敏度及特异度结论一致。不存在标本选择导致的评估结果差异。结论3种检测灵敏度相比:K≈W=R=安图>A。3家试剂特异度相比:R=安图=A>K≈W。Objective To evaluate the sensitivity and characterization of three widely used hepatitis A virus antibody(HAV-IgM)detection reagents in the domestic market.Methods To evaluate and compare the sensitivity and specificity of HAV-IgM detecting reagents of Zhengzhou Auto Bioengineering Co.,Ltd.,W company and K company,we purchased seracare(BBI)serum disk PHT202 and PHT903,and also collected clinical specimens on the market.Test results of R company′s HAV-IgM reagent were set as the standard,and the A company′s results were set for the reference.Results The sensitivity and specificity of the three manufacturers testing of two serum discs and collecting clinical specimens on the market were consistent.There were no differences in evaluation results due to specimen selection.Conclusion Comparison of sensitivity of 3 tests have shown that K≈W=R=Auto>A.Comparison of specificity of 3 reagents have shown that R=Auto=A>K≈W.

关 键 词：甲型肝炎病毒抗体 灵敏度 特异度 

分 类 号：R44[医药卫生—诊断学]