丙氨酸氨基转移酶检测方法确认

目的对献血者的丙氨酸氨基转移酶(ALT)采用速率法进行检测,并对这种方法进行性能验证,证明其满足ISO15189的要求。方法按照CNSA-CL02:2012《医学实验室质量和能力认可准则》及《血站技术操作规程》(2012版)的要求对检测系统的精密度、正确度、灵敏度、可报告范围、生物学参考区间以及测量不确定度进行验证。结果 ALT质控血清和两个浓度献血者标本检测20次和20d的批内不精密度5.0%,批间不精密度6.7%;正确度估计通过2014年的原卫生部室间质评结果分析和校准品结果分析,相对偏倚均小于1/2CLIA′88允许总误差;可报告范围用直线回归得到回归方程Y=0.995 1 X-5.618 4,r=0.999 7(R2=0.999 4),该检测范围内结果准确;生物学参考区间为0.0~32.7U/L;测量不确定度为(74.90±3.32)U/L。结论 ALT检测方法的性能指标均符合ISO15189的预期要求,该方法可以作为实验室的血液筛查检测方法。

Confirmation of ALT detection method

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 .