CAJ | 학술논문

目的：作为合作定值单位，用国际公认的参考物质进行胱抑素C国家候选标准物质的定值，协助北京市医疗器械检验所完成胱抑素C国家标准物质认证工作。方法根据国际参考物质ERM-DA471报告提供的靶值和定值程序，用该参考物质校准Hitachi 7180生化分析系统，测试经过6点稀释的国家候选标准物质。结果在定值结果重复性和互通性等良好的前提下，迈瑞定值结果作为有效结果参与标物靶值计算，成功协助北京市医疗器械检验所通过申请并获得了胱抑素C国家标准物质证书。结论定值结果与其他参与单位比对良好，并且内部评估无明显基质效应。
목적：작위합작정치단위，용국제공인적삼고물질진행광억소C국가후선표준물질적정치，협조북경시의료기계검험소완성광억소C국가표준물질인증공작。방법근거국제삼고물질ERM-DA471보고제공적파치화정치정서，용해삼고물질교준Hitachi 7180생화분석계통，측시경과6점희석적국가후선표준물질。결과재정치결과중복성화호통성등량호적전제하，매서정치결과작위유효결과삼여표물파치계산，성공협조북경시의료기계검험소통과신청병획득료광억소C국가표준물질증서。결론정치결과여기타삼여단위비대량호，병차내부평고무명현기질효응。
Objective As a collaborator of Beijing Institute of Medical Device Testing for value assignment of state standard ma-terial candidate Cystatin-C ,we have used the internationally accepted reference material to assign value for state standard material candidate Cystatin-C ,and help Beijing Institute of Medical Device Testing get Cystatin-C national standard material certificate . Methods According to the target value and operational procedure of international reference material ERM-DA471 ,We have tested 6 dilutions of standard material candidate Cystatin-C on calibrated Hitachi 7180 immunoassay system .Results The results demon-strate good repeatability and commutability ,and have been accepted in calculating the final value for the candidate standard materi-al ,our data has assisted Beijing Institute of Medical Device Testing in passing the criteria and obtaining Cystatin-C national standard material certificate .Conclusion Compared to the data from all participating collaborators ,our results hit right on the target value , and no significant matrix effects have been observed .