丙氨酸氨基转移酶检测系统溯源性研究

目的建立深圳市龙华人民医院院检验科丙氨酸氨基转移酶(ALT)检测系统的溯源性,提高最终检测结果的准确性。方法依据《GB/T 21415-2008/ISO 17511:2003》中的国际标准溯源链式图自建该医院检验科溯源流程图;购买参考物质IRMM ERM AD 454,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1/4CL IA’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。结果通过该医院自建的溯源流程实验,证明丙氨酸氨基转移酶试剂盒的产品校准品与IRMM ERM AD 454之间存在互通性,按照不确定度计算公式得到产品校准品的不确定度,赋值表示为135±5U/L。结论该医院检验科自建溯源流程成功对产品校准品进行了赋值修正,提高了试剂检测结果的准确性。

Traceability research on alanine aminotransferase measurement system

Objective To create the traceability of alanine aminotransferase measurement system in the laboratory of our hospital for improving the accuracy of final testing results. Methods To create the self-build hospital test traceability flow chart on the basis of traceability chain map in the GB/T 21415-2008/ISO 17511：2003 of international standards; to purchase the reference material （IRMM ERM AD 454）. First, the working calibrator provided by manufacturers was traced to reference material. Then the product calibrator was traced to manufactures working calibrator. The combination uncertainty was calculated for completing the tracing of the amount value of alanine aminotransferase product calibrator. The value assignment was135±5U/L. Results By testing and clinically comparing the fresh clinical serum samples, the interoperability of reference materials was ensured. Meanwhile, SPSS17.0 was adopted for statistical analysis. The total allowable error of the testing item 1/4CL IA＇88 and 97% prediction interval were used as the standard,the requirement of amount value transferring verification was reached. The uncertainty was further determined to complete the tracing job. The valae assignment was expressed as （135 ±5）U/L. Conclusion The hospital traceability flow chart is successfully established. The product calibrator is performed the valuation correction. The accuracy of the test results of reagents is improved.