脊髓灰质炎IgG抗体检测试剂参考品的制备及标定

Preparation and characterization of reference products for assay kit of IgG of poliomyelitis

目的建立脊髓灰质炎IgG抗体检测试剂参考品,为脊髓灰质炎IgG抗体检测试剂盒的性能评价提供可靠的质控品。方法通过中和实验对血清进行确认,获得了符合要求的血清,每个型别参考品有22份样品,包含10份阳性参考品、10份阴性参考品、1份最低检出量参考品、1份精密性参考品。结果脊灰病毒IgG抗体Ⅰ、Ⅱ、Ⅲ型阴性参考品符合率均不低于9/10,阳性参考品符合率均不低于8/10,精密性参考品变异系数均不高于15%,最低检出量参考品均不低于1∶8;参考品37℃放置5 d,反复冻融5次后稳定性良好。结论制备的脊髓灰质炎IgG抗体检测试剂参考品经各项试验检测结果合格,可用于脊髓灰质炎IgG抗体检测试剂的质控。

Objective Referance products were developed for assay kit of IgG of poliomyelitis to make it possible to reliably control quality of the assay kits in evaluating their properties. Methods Serum was confirmed through a neutralization test to obtain the serum which met requirements. Twenty-two samples were collected for each type of reference products, including 10 positive reference products, 10 negative ones, 1 reference product with the minimum detection limit and 1 precise reference product. Results The conformity ratio of type Ⅰ, Ⅱ and Ⅲ negative reference products of IgG of poliomyelitis was not below 9/10. The conformity ratio of positive reference products was not lower than 8/10,the coefficient of variation of precise reference was not higher than 15%, and the coefficient of variation of precise reference products was not lower than 1/8. The reference products were placed at 37℃ for 5 days. They were still quite stable after 5 repetitive freezing and thawing. Conclusion The prepared reference products of assay kit for IgG of poliomyelitis were tested to be qualified in all tests and could be used for quality control over such assay kits.