人巨细胞病毒IgG抗体质控盘的建立

The establishment of human cytomegalovirus IgG quality control panel

目的建立人巨细胞病毒IgG抗体质控盘,为以酶联免疫法和化学发光法为原理的人巨细胞病毒IgG抗体诊断试剂盒的性能评价提供可靠的质控物质。方法通过试剂盒筛选出人巨细胞病毒IgG抗体的阳性和阴性血清,将10份不同来源的阳性血清作为质控盘的P1~P10,5份不同来源的阴性血清作为质控盘的N1~N5,5份阳性血清混合制成质控盘的L1~L3。之后,用不同的试剂盒验证建立的质控盘。结果六家公司的试剂盒对本质控盘进行的准确性、特异性和检测限的验证结果均符合要求。对本质控盘的稳定性研究结果表明,质控盘的稳定性良好。成功建立了人巨细胞病毒IgG抗体质控盘。结论本研究建立的质控盘可用于以酶联免疫法和化学发光法等原理的人巨细胞病毒IgG抗体诊断试剂盒的性能评价。

Objective To establish the control panel for human cytomegalovirus IgG antibody detection kits,providing reliable control materials for the quality evaluations of these enzyme-linked immunosorbent or chemiluminescence based kits. Methods The positive and negative serums were selected by kits. The P1~P10 of the control panel were produced by 10 different sources of positive serums. The N1~N5 of the control panel were produced by 5 different sources of negative serums. The L1~L3 were produced by the mixture of 5 different sources of positive serums. Then,the control panels were verified . Results The results of accuracy, specificity, and detectability verified by detection kits of six different companies matched the requirements. The research of stability indicated these panels were stable enough. The control panels were established successfully. Conclusion The control panel is suitable for the quality evaluations of most human cytomegalovirus IgG detection kits,which are based on the principle of enzyme-linked immunosorbent assay and chemiluminescence ect.