Performance verification of HbA1c determination by using affinity chromatography
10.3969/j.issn.1673-4130.2014.17.040
- VernacularTitle:亲和层析法测定 HbA1c 的分析性能验证
- Author:
Jiasi ZHOU
;
Dongmei WEN
;
Ying CHEN
;
Quanzhong XU
;
Minghuan SUO
;
Lijuan KAN
;
Yaqiong CHEN
;
Xiuming ZHANG
- Publication Type:Journal Article
- Keywords:
glycosylated hemoglobin;
affinity chromatography;
performance verification
- From:
International Journal of Laboratory Medicine
2014;(17):2359-2361
- CountryChina
- Language:Chinese
-
Abstract:
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.
