Performance evaluation of angiotensin converting enzyme reagent kit
10.3969/j.issn.1673-4130.2015.07.034
- VernacularTitle:血管紧张素转化酶（ACE）试剂盒的性能评价
- Author:
Huiying XIE
;
Jing WU
;
Xinyue GE
;
Jiatao LOU
- Publication Type:Journal Article
- Keywords:
ACE;
performance evaluation;
sarcoidosis
- From:
International Journal of Laboratory Medicine
2015;(7):944-945
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the performance of self‐established angiotensin converting enzyme (ACE) detection system . Methods The performance evaluation of ACE reagent kit produced by the Jiuqiang Company including precision ,linearity ,correla‐tion with the reference reagent and reportable range were conducted by using the automatic biochemical analyzer according to the re‐quirements of the EP5‐A2 and EP9‐A documentation in the Clinical and Laboratory Standards Institute (CLSI) .Results Intra‐as‐say CV of the system were 6 .87% ,2 .39% and inter‐assay CV were 6 .09% ,1 .81% ,respectively .During the day CV were 8 .00 %and 2 .8% respectively ,which were less than those provided by the manufacturer (<10% );the lenearity result was R2 =0 .99 .The correlation coefficient (r) of the system comparing with the reference reagent was 0 .990 56 ,moreover the average bias was 8 .55% , showing good correlation ;the repotable range was 9 .0U/L‐600U/L .Conclusion Self‐established ACE detection system can meet the requirements for clinical application .
