摘要
目的:建立风疹病毒(RV)IgM抗体质控盘,质控盘包括风疹病毒抗体阳性血清P1～P5,抗体阴性血清N1～N10,以及用于评价试剂盒灵敏度的血清L1～L3。此质控盘为以酶联免疫法和化学发光法为原理的风疹病毒(RV)IgM诊断试剂盒的性能评价提供了可靠的质控物质。方法:通过试剂盒筛选出风疹病毒IgM的阳性和阴性血清,将5份不同来源的阳性血清作为质控盘的P1～P5,将10份不同来源的阴性血清作为质控盘的N1～N10,将5份阳性血清混合制成质控盘的L1～L3,之后,将建立的质控盘用不同的试剂盒进行验证。结果:不同的试剂盒对质控盘的验证表明成功地建立了风疹病毒(RV)IgM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风疹病毒(RV)IgM诊断试剂盒的性能评价。
Objective：To establish the control panel the positive serum P1 - 175, the negative serum N1 - for rubella virus （RV）lgM antibody detection which involves N10, and the L1 - L3 used to evaluate the sensitivity of kits and is designed to provide a reliable quality control substance for performance evaluation of the RV IgM diagnosis kit based on euzymelinked immunosorbent assay （ELISA）and chemiluminescence （CLIA）. Methods： The positive and negative sera were selected by kits, of which five positive serum of different sources were taken as control plate P1 - PS, 10 different sources of negative serum as control plate N1 - N10, the L1 - L3 was produced by the mixture of 5 positive serum of different sources. Then, the established panel was verified with different kits. Results： The control panel for RV IgM antibody was proved to be successfully established through the verification of the different kits. Conclusion：The quality control panel can be used for the performance evaluation of most RV IgM diagnosis kits which are based on principles of enzyme - linked immunosorbent assay and chemiluminescence, etc.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第1期1-6,共6页
Chinese Journal of Pharmaceutical Analysis
基金
体外诊断试剂国家标准品对照品标定及复核(课题编号:2011604)
