两种白喉IgG抗体酶联免疫吸附试验检测试剂盒的评价

Comparison of Two Commercial Enzyme-linked Immunosorbent Assays for Detection of IgG Antibody to Diphtheria

目的对IBL公司和Virion公司白喉IgG抗体酶联免疫吸附试验(ELISA)检测试剂盒进行评价,以获得试剂盒的稳定性和准确度的相关数据。方法购买IBL和Virion公司的白喉IgG抗体ELISA检测试剂盒,检测标本来自31份健康从业人员体检血清以及试剂盒内标准品。标准品同时进行10孔检测,血清样品双孔检测,标准品每天检测1次,共检测3次。分析试剂盒检测结果的批内差异及批间差异以检测其稳定性,将标准品的测得浓度与实际浓度相比较,评价试剂盒的准确度。结果IBL试剂盒标准品检测的批内变异系数(Coefficient of Varia-tion,CV)为13.550 7%,批间CV为9.989 0%;血清样品检测的批内CV为14.527 0%,批间CV为11.003 9%。Virion试剂盒标准品检测的批内CV为5.9541%,批间CV为2.472 8%;血清样品检测的批内CV为11.061 2%,批间CV为8.030 0%。标准品的测得浓度与实际浓度之间的CV:IBL试剂盒为17.688 9%,Virion试剂盒为1.396 6%。IBL和Virion试剂盒检测结果与间接血球凝集试验(IHA)检测结果的符合率均为65%。结论两公司试剂盒的检测结果均满足试剂盒自身的质量控制标准,CV满足ELISA的常规质量控制标准(CV<20%)。标准品的测得值和实际值之间比较,Virion试剂盒的CV较小。与IHA相比,两种试剂盒的符合率相同。

Objective To compare the performance of two commercially available ELISA kits for detection of diphtheria IgG antibody to provide data for the proper kit choice. Methods Thirty- three serum samples from staff of the capital airdrome and two standard sera were tested for the evaluation of the kits. Commercial ELISAs were compared with respect to their reproducibility （intra-assay variation and inter-assay variation）and accuracy. Results For the detection of standard serum,intra-assay variation（Coefficient of Variation, CV）was 13. 5507% for IBL kit and 5. 9541% for Virion kit,the inter-assay variation（CV）was 9. 9890% for IBL and 2. 4728%o for Virion kit. For the serum sample, intra-assay variation （CV） was 14. 5270 % for IBL and 11. 0612 % for Virion,the inter-assay variation（CV）11. 0039% for IBL and 8. 1506% for Virion kit. For the detection of standard serum,inter-assay variation（CV）was 9. 9890% for IBI, and 2. 4728% for Virion. The accuracy was analyzed by variation between the actual concentration and measured concentration of standard serum.the CV was 17.6889% for IBL and 1.3966% for Virion .Conclusion The intra-assay and inter-assay variation of the two kits are generally acceptable （CV〈20%）,and the variation（CV） between the actual concentration and measured concentration of standard serum for Virion kit is lower than IBL. The accordance of IBL assay with IFA assay is the same as Virion assay.