血清淀粉样蛋白A测定试剂盒质量评价与行业标准验证

Industry standard verification and quality evaluation for serum amyloid A assay kit

目的评价已上市血清淀粉样蛋白A测定试剂盒质量并对建立的行业标准进行验证。方法验证试剂盒的空白限、检出限、准确度、线性、重复性性能指标与验证方案的符合性;同时评价国际标准物质在试剂盒之间的互换性。结果大部分参与验证的血清淀粉样蛋白A测定试剂盒的空白限、检出限、准确度、线性、重复性验证结果满足行业标准要求;但59%的系统组合一致性较差;国际标准物质NIBSC92/680在大约37%的系统组合上有互换性。结论绝大多数试剂盒的验证结果能满足制定的行业标准的要求;部分试剂盒存在基质干扰,导致测定结果的一致性还有待提高;另外,企业在使用国际标准物质NIBSC92/680溯源前应验证互换性。

Objective To evaluate the quality of serum amyloid A(SAA)assay kits on the market and verify the established industry standard.Methods The consistency for the various applicable indexes of the SAA assay kits was conformed with the validation proto-col in the industry standard,including limit of blank(Lo B),limit of detection(Lo D),accuracy,linearity and repeatability.The com-mutability of International Standard Material in these SAA kits was also evaluated.Results Most of the SAA kits met the industry standard in terms of Lo B,Lo D,accuracy,linearity and repeatability,however,59%of the system combinations showed poor consis-tency.The international standard material NIBSC92/680 was interchangeable in about 37%of the SAA kit combinations.Conclusion The verification results showed most available SAA kits met the requirements of the established industry standard.The relatively low consistency of some kits,which needs to be improved,may be due to the interference of samples matrix.The manufacturers of SAA kits should verify the commutability before using the international standard material NIBSC92/680 for traceability.