5种市售弓形虫抗体检测试剂盒的评价

Evaluation of five commercial available kits for detecting antibodies of Toxoplasma gondii

目的 评价国内公司研制的 5种弓形虫抗体检测试剂盒。方法 以敏感性、特异性、符合率和Youden指数作分析指标 ,比较 5种试剂盒对国外进口的 2种弓形虫抗体试剂盒筛选出的弓形虫IgG或IgM阳性血清和正常人血清的检测结果。结果 A、B、C 3种IgM试剂盒的检测敏感性和特异性分别为 0和 92 1%、6 7%和 10 0 %、以及 13 3%和 85 7% ,Youden指数分别为 - 0 0 8、0 0 7和 - 0 0 1,基本无诊断价值。A’、B’ 2种IgG试剂盒的检测敏感性分别为 96 4 %和 32 1% ,特异性为 98 4 %和 96 8% ,Youden指数为 0 95和 0 2 9。A’试剂盒与进口IgG试剂盒的符合率达到 97 8% ,诊断价值较大 ,而B’试剂盒与进口试剂盒的符合率仅为 76 9% ,A’、B’ 2种试剂盒之间的符合率也只有 76 9%。结论 国内研制的市售弓形虫试剂盒的检测效果与质量存在一定的问题 ,尤以IgM试剂盒为甚。

Aim To evaluate five Toxoplasma gondii antibody kits in Shanghai market Methods Differences of these kits were compared for their sensitivity,specificity,efficiency and Youden index from 106 serum samples (15 IgM positive,28 IgG positive,and 63 negative) Results The sensitivity and specificity of three anti Toxoplasma gondii IgM antibody kits were 0 and 92 1%,6 7% and 100%,and 13 3% and 85 7%,respectively The Youden indices of the IgM kits were all below 0 1 and showed no diagnostic value Of anti Toxoplasma gondii IgG antibody kits,one kit (A') was found to be of most diagnostic value in sensitivity,specificity,efficiency and Youden index (which was 96 4%,98 4%,97 8% and 0 95,respectively),while another kit (B') showed unacceptable for diagnostic value Conclusion The quality of domestic commercial kits for diagnosis of Toxoplasmosis must be improved