1.Confirmation of ALT detection method
Fufang ZENG ; Dan WU ; Ji ZHOU ; Fang TIAN ; Dongju PENG
International Journal of Laboratory Medicine 2016;37(17):2406-2407,2410
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 .

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