亲和层析法测定 HbA1c 的分析性能验证

目的：验证验证 Primus Trinity Ultra2分析仪测定 HbA1c 的精密度、准确度、分析测量范围和抗干扰能力的可接受性。方法参照美国临床与实验室标准化协会（CLSI）EP 文件及相关文献对 Primus Trinity Ultra2分析仪测定 HbA1c 的精密度、准确度、分析测量范围和抗干扰能力进行验证。结果 Trinity Ultra2分析仪检测 HbA1c 精密度的批内不精密度和总不精神度均小于厂商声明的不精密度值；Trinity Ultra2分析仪测定定值参考物的结果均在各自的验证区间；Trinity Ultra2分析仪在线性验证中，通过测定按一定比例稀释后的标本，得到了理论值与实测值间的回归方程，r2＞0．95，a 值在0．97～1．03的范围内；Trinity Ultra2分析仪有良好的抗黄疸、溶血、脂血、乳糜等干扰物质的能力。结论 Primus Trinity U1tra2分析仪亲和层析法的主要分析性能均达到厂商声明的性能和有关质量的要求，可满足临床需求。

Performance verification of HbA1c determination by using affinity chromatography

Objective To evaluate the precision,accuracy,linear range and anti-interference performance of HbA1c assay by u-sing Primus Trinity Ultra2 automated analyzer.Methods According to Document EP published in 2004 by American Clinical and Laboratory Standards Institution（CLSI）and relative literatures,the precision,accuracy,linear range and anti-interference perform-ance were evaluated.Results The within-run and between-run CVs of HbA1c determination were both less than that announced by manufacture.In the tests of samples with certain concentrations,all the results were within the verification range respectively.In the linear verification,regression equation between the theoretical and measured values demonstrated that r2 〉0.95,and a value was within the range of 0.97-1.03.For Primus Trinity Ultra2 the limit of interference effect didn′t exceed the allowable error at the medical decision concentrations.Conclusion The precision,accuracy,linear range and anti-interference was evaluated of the Primus Trinity Ultra2 automating HbA1c all could meet the manufacture′s declaim and the clinical needs.