依据CNAS-GL037在罗氏Cobas8000全自动免疫分析仪上进行CA19-9性能验证

A Performance Verification of CA19-9 on Roche Cobas8000 Automatic Immune Analyzer According with CNAS-GL037

目的建立本实验室性能验证的标准化方法,为日后性能验证工作提供参考。方法按CNAS-GL037推荐的方法对CA19-9进行正确度、精密度、线性范围、可报告范围、生物参考区间的验证,实验结果在厂家声称的范围内或是满足本实验室的执行标准为性能验证通过。结果室间质评5个质控样本的检测结果均落在规定范围内,正确度验证通过;CA19-9两个水平质控品的重复标准差分别为0.47、1.17,期间标准差分别为0.52、1.61,均小于厂家给定的数值;最优拟合曲线为一阶方程Y=1.000X-0.004,R2=0.998(P<0.05),在34.29~983.60 U/mL的范围内线性关系良好;可报告范围低值取稀释20倍的检测值1.78 U/mL(CV=9.44%),3个高值样本最高稀释20倍时性能均可达到良好(偏倚<12.5%),可报告范围为20000 U/mL;20名健康查体者检测结果均落在厂家给定的参考区间内(0.1~37 U/mL)。结论依据CNAS-GL037进行罗氏CA19-9的正确度、精密度、线性范围、可报告范围、生物参考区间验证,结果均符合检测要求。

Objective To establish a standardized method for the performance verification in the laboratory and to provide a reference for the future performance verification work.Methods The accuracy,precision,linear range,reportable range and biological reference interval of CA19-9 were verified according to the recommended method of CNAS-GL037.The results within the range claimed by the manufacturer or meeting the standard of our laboratory represented the performance verification passing.Results The test results of 5 external quality assessment samples were all in the prescribed range,and the accuracy passed the validation.The repeated standard deviations of two levels of CA19-9 quality control were 0.47 and 1.17.The intermediate standard deviation were 0.52 and 1.61,which were less than the value provided by the manufacturer.The optimal fitting curve was a first order equation 34.29-983.60,R2=0.998(P<0.05),and it has a good linear relationship in the range of 34.29-983.60 U/mL.The low value of reportable range was 1.78 U/mL(CV=9.44%),with the dilution by a factor of 20.The performance of the three high-value samples was good at the maximum dilution of 20 times(bias<12.5%),so the high value of reportable range was 20000 U/mL.Results from 20 healthy examiners all fell within the reference interval(0.1-37 U/mL)provided by the manufacturer.Conclusion The accuracy,precision,linear range,reachability range and biological reference interval of Roche CA19-9 are verified according with CNAS-GL037,and all the results meet the detection requirements.