化学发光法测定CA50及CA242方法学评价*

目的：对科美CHEMCLIN 1500全自动化学发光免疫分析仪检测肿瘤相关抗原50（CA50）、肿瘤相关抗原242（CA242）的分析性能进行方法学验证。方法：参照美国临床实验室标准化委员会（NCLLS）EP文件要求，应用科美CHEMCLIN 1500全自动化学发光免疫分析仪定量测定CA50、CA242，评价检测CA50、CA242的精密度、正确度、检出限和分析测量范围。结果：CA50、CA242批内精密度变异系数均＜15%，批间精密度变异系数均＜15%；测定CA50、CA242定值校准品与靶值的偏倚＜5%，正确度满足判断标准；CA50、CA242检出限分别为0.68 U/mL、0.56 U/mL；CA50浓度在19.43～131.55 U/mL范围内其测定的线性相关系数r2为0.9895，CA242在15.86～191.25 U/mL范围内其测定的线性相关系数r2为0.9971。结论：本次研究所验证的科美CHEMCLIN 1500全自动化学发光免疫分析仪检测CA50、CA242的精密度、正确度、检测限、线性范围均与厂家声称值一致，表明该检测系统具有精密度好、正确度高、良好的线性等优点，能够满足临床检测的性能要求。

Methodological evaluation of Chemiluminescence for determining CA50 and CA242

Objective:To evaluate the reliability of the quantitative determination of CA50 and CA242 by using CHEMCLIN1500 automatic chemiluminescence immunoassay analyzer. Methods:According to the EP documents by U.S.Committee for Clinical Laboratory Standards(NCLLS) recommended, CA50 and CA242 were detected by CHEMCLIN1500 automatic chemiluminescence immunoassay analyzer, and the precision, accuracy, detection limit and analytical measurement range were evaluated. Results:The within-run coefficients of variation (CV) of CA50 and CA242 were less than 15%. The between-run coefficients of variation (CV) were less then 15%. The bias of calibrator between the measure value and the target value were less than 5%. The accuracy meeted the evaluation criteria. The detection limit of CA50 and CA242 were 0.68 U/mL and 0.56 U/mL respectively. The liner correlation coefficient (r2) of CA50 was 0.9895 from 19.43~131.55 U/mL. The liner correlation coefficient (r2) of CA242 was 0.9971 from 15.86~191.25 U/mL. Conclusion:The results of verification test showed that the precision, accuracy, detection limit and analytical measurement range were met with the factory. This suggests that CHEMCLIN1500 automatic chemiluminescence immunoassay analyzer is accurate and safe for determining CA50 and CA242, and is suitable for clinical application.