【摘要】 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。更多还原

【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-CL02:2012the Medical Laboratory Quality and Ability 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 intrabatch imprecision for the ALT quality control serum and 2concentrations 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′88permissible error;the regression equation of reportable range obtained by the linear regression was Y=0.995 1 X-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.更多还原