Comparison and clinical acceptability estimation of myocardial enzyme spectrum detection results by two systems
10.7687/J.ISSN1003-8868.2015.09.090
- VernacularTitle:2种检测系统心肌酶谱结果的比对分析与临床可接受性评价
- Author:
Chengjun XUE
;
Zhishui CHEN
;
Rong YUAN
;
Lijuan CUI
;
Yongjun WANG
;
Jieke ZHANG
- Publication Type:Journal Article
- Keywords:
comparative test;
myocardial enzyme spectrum;
clinical acceptability estimation
- From:
Chinese Medical Equipment Journal
2015;(9):90-92,154
- CountryChina
- Language:Chinese
-
Abstract:
To study the comparability of myocardial enzyme spectrum detection results by two different bio-chemical testing systems to provide references for mutual accredit of detection results in one lab. Following NC-CLS document EP9-A2, 8 clinical specimens were selected every day for five days and tested for AST, LDH, CK and CK-MB respectively with Siemens ADVIA1800 and Johnson & Johnson Victro350 systems. Acknowledging Siemens AD-VIA1800 as objective testing system, the results were utilized to make correlation analysis and clinical acceptability esti-mation. There was high precision in Siemens ADVIA1800 and Johnson & Johnson Victro350 (CV≤1/3CLIA′88 allowable error). It's proved by t test that the difference of the myocardial enzyme results tested with Siemens ADVIA1800 and Johnson Victro350 was statistically significant (P<0.01), while the two testing systems showed significant correlation (r>0.975). In the comparison with the Siemens ADVIA1800, the standard errors (SE%) of AST, CK and CK-MB tested with Johnson Victro350 were 4.0%-6.6%, 9.6% and 13.3%, which were accepted by clinical standard; while the SE% of LDH tested with Johnson Victro350 were 11.2%-12.7%, which were beyond clinically acceptable range. In case one item is tested by different testing systems in one laboratory, the comparison and bias estimation acceptable eval-uationare necessary to judge the clinical acceptability, which can ensure the accuracy and consistency of the results.