肌酐检测系统溯源性研究

Traceability study on creatinine measuring system

目的建立新成生物肌酐检测系统的溯源性,提高用户最终检测结果的准确性,为检测结果互认提供条件。方法依据《GB/T 21415-2008/ISO 17511:2003》中的国际标准溯源链式图自建新成生物溯源流程图;购买参考物质NIST SRM 909b,首先将厂商工作校准品溯源至参考物质,然后将产品校准品溯源至厂商工作校准品,并计算合成不确定度,完成新成肌酐产品校准品的量值溯源。结果通过测定临床新鲜血清标本进行临床比对确保参考物质具有互通性,同时采用SPSS17.0进行统计学分析,以97%的预测区间和检测项目1/4CLIA′88总允许误差为标准,达到量值传递验证要求,进一步确定不确定度,完成量值溯源工作。结论新成生物自建溯源流程成功对产品校准品进行了赋值,实现了产品校准品的溯源,提高了新成试剂检测结果的准确性。

Objective To create the traceability of XC Test′s creatinine measurement system,and improve the accuracy of customers′ final test results,and contribute to the mutual recognition of the test results.Methods We created XC Test′s own traceability flow chart on the basis of traceability chain map according to the GB/T 21415-2008/ISO 17511：2003 document of international standards;and purchased reference material（NIST SRM 909b）.Firstly,we traced the manufacturer′s working calibrator to the reference material.Then traced the product calibrator to manufacture′s working calibrator and calculate the uncertainty of the combination,to complete the tracing of the value of creatinine product calibrator made by XC Test.Results By testing and comparing the fresh clinical serum samples to ensure reference materials had interoperability.Meanwhile,we adopted SPSS17.0 to analyze the data statistically.We took the standard of the 1/4CLIA′88 of testing projects and a total allowable error of 97% prediction interval in order to meet the requirements of value transferring verification,and then ensured the uncertainty and completed the tracing job.Conclusion XC Test is successful in assigned the product calibrator with the built-in traceability and improves the accuracy of the test results of reagents generated.