风疹病毒(RV)IgM抗体质控盘的建立
The establishment of quality control panel for rubella virus(RV)IgM antibody
分类号:
出版年·卷·期(页码):2013,33 (1):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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。
-----英文摘要:---------------------------------------------------------------------------------------
Objective: To establish the control panel for rubella virus (RV) IgM antibody detection which involves the positive serum P1-P5, the negative serum N1-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-P5, 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.
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