Traceability research of XC Test′ s creatinine measurement system
Tan Tao · Modern Medicine Health · 2011
Objective:To establish the traceability of XC Test ′ s creatinine measurement system and to improve the accuracy of customers′ final test results and contribute to the mutual recognition of the test results.Methods:To create XC Test ′s own traceability flow chart on the basis of traceability chain map in the GB/T 21415-2008/ISO 17511:2003 of international standards and to purchase reference material(NIST SRM 909b).First,the manufacturers working calibrator was traced to reference material.Then the product calibrator was traced to manufactures working calibrator and the uncertainty of the combination was calculated 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 have interoperability.Meanwhile,adopting SPSS17.0 for statistical analysis,under the standard of the 1/4CL IA′ 88 total allowable error of 97% prediction interval and testing projects,amount to the requirement of value transferring verification,to further make sure the uncertainty till complete the tracing job.Conclusion:The creation of XC Test′ s self-built traceability process succeeds in assigning to the product calibrator,which realizes the tracing of product calibrator and improves the accuracy of the test results of reagents manufactured by XC Test.