Confirmation of ALT detection method
10.3969/j.issn.1673-4130.2016.17.019
- VernacularTitle:丙氨酸氨基转移酶检测方法确认
- Author:
Fufang ZENG
;
Dan WU
;
Ji ZHOU
;
Fang TIAN
;
Dongju PENG
- Publication Type:Journal Article
- Keywords:
alanine aminotransferase;
confirm;
performance verification
- From:
International Journal of Laboratory Medicine
2016;37(17):2406-2407,2410
- CountryChina
- Language:Chinese
-
Abstract:
Objective To confirm the performance of rate method for detecting ALT in blood donors to verify that it meets the requirements of ISO15189 .Methods according to the requirements of CNSA‐CL02 :2012 the Medical Laboratory Quality and Abili‐ty Recognized Standards and the Blood Station Technical Operation Regulations(edition 2012) ,the precision ,accuracy ,sensitivity , reportable range ,biology reference interval and measurement uncertainty of the detection system were verified .Results The intra‐batch imprecision for the ALT quality control serum and 2 concentrations of blood donor sample detected for 20 times and 20 d was<5 .0% and the inter‐batch imprecision was <6 .7% ;the correct estimates passed the external quality assessment results of the original Ministry of Public Health in 2014 and calibration results analysis .The relative bias was less than 1/2 of CLIA′88 permissi‐ble error;the regression equation of reportable range obtained by the linear regression was Y =0 .995 1X -5 .618 4 ,r=0 .999 7 (R2 =0 .999 4) ,the results within the detection range were correct ;the biological reference interval was 0 .0 -32 .7 U/L and the measurement uncertainty was (74 .90 ± 3 .32)U/L .Conclusion The performance indexes of ALT detection method conform to the expected requirements of ISO15189 .This method can be used as a blood screening test method in laboratory .
