Evaluation of analytical performance of open automatic biochemistry analysis systems measuring cholesterol
10.3760/cma.j.issn.1009-9158.2013.09.007
- VernacularTitle:开放式胆固醇测定自动生化分析系统的性能评价
- Author:
Chuanbao ZHANG
;
Haijian ZHAO
;
Rong MA
;
Jiangtao ZHANG
;
Shu WANG
;
Wenxiang CHEN
- Publication Type:Journal Article
- Keywords:
Cholesterol;
Automation;
Clinical chemistry tests
- From:
Chinese Journal of Laboratory Medicine
2013;36(9):801-805
- CountryChina
- Language:Chinese
-
Abstract:
Objective to evaluate the analytical performance of 7 open automatic biochemistry analysis systems in terms of precision,linearity,anti-interference ability and trueness on determination of cholesterol.Methods Performance verification test.There were 7 open analysis measurement systems composed of 7 kits as well as calibrators from Biosina,Baiding,Fosun,Dongou,Kehua,Maker and Wako company respectively,and Hitachi 7170 automatic analyzer were chosen as test systems.The repeatability CV and inter-lab CV were assessed according to Clinical and Laboratory Standards Institute (CLSI) protocol EP5-A2.The linearity range was evaluated on the basis of CLSI EP6-A,the series concentrations of cholesterol were 0,2.07,4.14,6.21,8.28,10.35,12.93,20.69 and 25.86 mmol/L cholesterol.Hemoglobin,ascorbic acid (vitamin C) and intralipid were applied as interfere materials in interference testing according to CLSI EP7-A2.The trueness was evaluated on the basis of China national lipids standardization program,the concentrations of 10 samples ranged from 2.88 to 5.42 mmol/L measured by reference methods.Results When the low level sample (2.71 mmol/L) measured,the repeatability CV were 0.54％,0.79％,0.56％,0.51％,0.56％,0.48％ and 0.49％ respectively,intra-lab CV were 1.00％,1.06％,1.28％,0.89％,1.08％,1.13％ and 1.05％ respectively.When the high level sample (5.12 mmol/L) measured,the respective repeatability CV were 0.40％,0.41％,0.51％,0.48％,0.47％,0.45％ and 0.47％,the respective intra-lab CV were 0.82％,0.69％,1.27％,0.70％,0.70％,1.08％ and 0.69％.The upper limits of linearity range of A,B,D,F was 12.93 mmol/L and for C,E,G was 20.69 mmol/L.There is no significant interference on 7 systems with chyle concentration of 1.6％ or hemoglobin concentration of 4 g/L.Given the interference bias ≤ 4％,the interference concentrations of ascorbic acid were 228,215,225,2840,2840,217 and 2840 μmol/L respectively.In trueness verification experiment,the bias of 7 systems all met the target value (≤ 3％).Conclusion The analytical performance of 7 systems in terms of precision,linearity,trueness and anti-interference all met the requirements of clinical specifications.The performance of anti-interference and measurement trueness of several systems could be improved.
