Comparative analysis on results of 6 serum enzymes detected by Hitachi 008 and ARCHITECT C16000 biochemical analyzers
10.3969/j.issn.1673-4130.2014.16.051
- VernacularTitle:日立-008和雅培 ARCHITECT C16000生化分析仪检测6种血清酶结果比对分析
- Author:
Juan ZHANG
;
Xiaoyan JIANG
;
Shunjun LI
;
Wenfang HUANG
- Publication Type:Journal Article
- Keywords:
serum enzymes;
accuracy;
precision;
comparative study;
bias
- From:
International Journal of Laboratory Medicine
2014;(16):2237-2238,2240
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the comparability of the activity detection of 6 common serum enzymes by different bio-chemical detecting systems at the same laboratory to provide the basis for realizing the traceability and comparability of serum en-zyme detection.Methods The detection system consisted of the Hitachi 008 biochemical analyzer,and original reagents,C-fas cali-brator and controller of Roche was taken as the reference system X(comparison method)and the detection system consisted of the ABBOTT ARCHITECT C16000 biochemical analyzer,reagents and calibrator of Zhongsheng,and controller of BIO-RAD was taken as the detecting systemY (laboratory method),which were used to detect the accuracy and precision of fresh serum enzymes inclu-ding ALT,AST,ALP,GGT,LDH and CK according to the NCCLS document EP9-A2.Then the enzyme activity results detected by the Y and X methods were compared and the relative error(SE%)was calculated.The comparability of the results detected by these two kinds of different detection systems was judged with 1/2 of allowable error in the external quality assessment stipulated by CLIA′88 as the standard.Results The accuracy and precision of the activity detection results of 6 enzymes by the Hitachi 008 and ARCHITECT C16000 biochemical analyzers all conformed to the requirements and the systematic error was clinically acceptable. Conclusion In measuring same test item by two or more detection systems,the method comparability and the bias assessment should be performed for ensuring the accuracy and comparability of the detection results.
