半胱氨酸蛋白酶抑制剂C测量系统正确度及一致性评价

An Assessment of Accuracy and Consistency of Cystatin C Measurement System

目的比较半胱氨酸蛋白酶抑制剂C测量系统检测结果的正确度和一致性。方法在日立7170A全自动生化分析仪上分别用九强、迈瑞、中元、德赛、景源、迈克、罗氏、积水、瑞源9个系统测量IRMM有证参考物质ERM-DA471/IFCC和42份临床剩余血清样本。参考EP14-A3文件,评价ERM-DA471/IFCC在各比对系统中的互通性;对计算ERM-DA471/IFCC测量值与靶值的偏倚进行正确度验证;参考CLSI EP9-A3文件,以42份血清结果进行方法学比对,将本实验室现用方法九强系统作为参比方法,与其余8个系统进行回归分析,并计算医学决定水平处的偏倚。结果以临床可接受范围为评价标准,ERM-DA471/IFCC在8组比对系统均有互通性。9个系统测量ERM-DA471/IFCC的结果中,除中元和景源高于10%外,其他系统均在1.09%~9.61%范围内。医学决定水平处的预期偏倚中,中元在1mg/L处的偏倚为10.68%,其他三个水平处的偏倚小于10%,景源在4个医学决定水平处的偏倚均大于10%,剩余6个系统偏倚在-0.04%~6.26%范围内,故除中元和景源外其他系统与九强系统的相关性较好。结论评估的9个系统除中元和景源外,其他6个系统与九强系统的一致性较为理想。

Objective To assess the accuracy and consistency of cystatin C measurement systems.Methods IRMM reference material ERM-DA471/IFCC and 42 clinical residual serum samples were measured using Hitachi 7170A with reagents from nine manufacturers,including BSBE,Mindray,Zybio,DiaSys,Jingyuan,Maccura,Roche,Sekisui and Ruiyuan.Referring to EP14-A3 to evaluate the interoperability of ERM-DA471/IFCC among comparison systems.The bias of ERM-DA471/IFCC was calculated for correctness verification.Referring to CLSI EP9-A3,42 serum results were used for methodological comparison.BSBE system currently used in our laboratory were used as reference methods,and regression analysis was performed with the remaining eight systems to calculate the bias at the level of medical decision.Results 8 groups of comparison systems demonstrated commutability of ERM-DA471/IFCC based on clinically acceptable range.Among the nine conventional measurement systems,except for Zybio and Jingyuan,which were slightly higher than 10%,the other systems were in the range of 1.09%to 9.61%.Among the expected bias at the medical decision level,the bias of Zybio at 1mg/L was 10.68%,the bias of the other three levels was less than 10%,the bias of Jingyuan at the four medical decision levels were all more than 10%,and the bias of the remaining 6 systems ranged from-0.04%to 6.26%,indicating that all other systems,except for Zybio and Jingyuan,had a good correlation.Conclusion In addition to Zybio and Jingyuan,the consistencies of the other six systems are satisfactory with BSBE system.