Evaluation of the Performance of 7 homogeneous direct reagents for HDL-cholesterol
10.3760/cma.j.issn.1009-9158.2009.05.009
- VernacularTitle:高密度脂蛋白胆固醇测定匀相法试剂评价
- Author:
Haijian ZHAO
;
Hanbang GUO
;
Chuanbao ZHANG
;
Hongxia LI
;
Jun DONG
;
Shu WANG
;
Wenxiang CHEN
- Publication Type:Journal Article
- Keywords:
Cholesterol,HDL;
Indicators and reagents;
Chromatography,high pressure liquid;
Evaluation studies
- From:
Chinese Journal of Laboratory Medicine
2009;32(5):521-525
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the analytical performance of 7 homogeneous HDL-cholesterol reagents. Methods An altracentrifugation-HPLC method was used as the comparison method. Fourty fresh patient samples were analyzed by homogeneous methods and the comparison method. The homogeneous methods were all performed on a Hitachi 7170A chemistry analyzer according to the manufacturer's instructions, Precision, accuracy and total errors were analyzed. Results The homogeneous assays typically demonstrated within run coefficient variance(CV) of < 1%, and total CV of < 3%. Methods A, B and D showed average bias, bias at the medical decision points and total errors all within the NCEP performance criteria and method C and F unacceptable biases (-19.74% and 11.46%, respectively) and total errors according to the NCEP criteria. However, all the homogenous methods (A-F) had total errors of < 30%, as required by the US Clinical Laboratory Improvement Amendment (CLIA). Conclusions Homogeneous HDL-C assays have been shown to be reasonably precise, but discrepant results have been observed with some of the assays. Clinical laboratories should pay more attention on selecting and validating homogeneous HDL-C reagents.
