Traceability study on creatinine measuring system
Tan Tao · Laboratory Medicine and Clinic · 2011
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.