检测弓形虫IgM抗体的3种试剂盒的比较分析

EVALUATION OF THREE COMMERCIAL IgM-ELISA KITS FOR DETECTING ANTIBODIES OF TOXOPLASMA GONDII

目的 评价用于检测弓形虫IgM抗体的 3种市售的试剂盒。 方法 用 3种试剂盒检测 12 5份孕妇的血清 ,比较各试剂盒的阳性检出率、敏感性、特异性和试验效率等。结果 12 5份血清经Bi、Di和So试剂盒检测 ,分别有 12 .8%、15 .2 %和 12 .0 %阳性 ,3种试剂盒检测血清的阳性率之间无显著性差异 (P >0 .0 5 )。Bi、Di和So试剂盒的敏感性和特异性分别为88.9%与 10 0 %、10 0 %与 99.1%和 83.3%与 10 0 % ,试验效率分别为 98.4%、99.2 %和 97.6 %。用WHO国际生物标准化实验室的抗弓形虫血清标准品定量测得 3种试剂盒的灵敏度都是 0 .31IU/ml。Bi试剂盒与Di试剂盒的总符合率为 97.6 % ;Di试剂盒与So试剂盒的总符合率为 96 .8% ;Bi试剂盒与So试剂盒的总符合率为 97.6 %。结论 这 3种试剂盒都能用于弓形虫IgM抗体的常规普筛和血清学诊断。

Aim To evaluate three commercial ELISA kits for detecting IgM antibodies to Toxoplasma gondii.Methods A total of 125 pregnant women serum samples were assayed by kit Bi,Di and So.Results Positive rates by the three kits were 12 8%,15 2% and 12 0%,respectively.No significant statistical difference was found among these positive rates(P>0.05).The sensitivity and specificity of the kit Bi,Di and So were 88.9% and 100%,100% and 99.1%,and 83.3% and 100%,respectively.The detection efficiency of the three kits is 98.4%,99.2% and 97.6% respectively.The three kits enable the detection of IgM antibodies to Toxoplasma gondii approximately 0.31 IU/ml.High agreements were found between kit Bi and kit Di(97.6%), kit Di and kit So.(96.8%) and kit Bi and kit So(97.6%).Conclusion The three kits are of good agreement and can alternatively be used for screening and determination of IgM antibodies to Toxoplasma gondii.