Exploring the Development of Reference Materials for Biochemical and Immunological in vitro Diagnostic Reagents by Taking the Human Creatinine Serum Reference Material as the Representative
Objective:To explore potential problems in current reference materials development by selecting one representative with important clinical significance for evaluation,and to discuss the optimization of produced path according to the results to better improve the standardization of inspection reference system,based on the status of biochemical and immunological standard reference materials in the clinical reference system.Methods:According to the standards of EP14-A3 of the Clinical and Laboratory Standards Institute and WS/T 356-2011 of the National Center for Clinical Laboratories,the evaluation scheme was set up.4 creatinine in frozen human serum reference materials produced by reference methods from two different domestic organizations and 21 fresh human serum samples,were tested by reference methods of isotope dilution mass spectrometry and conventional methods of sarcosine oxidase according to the scheme.After processing the test results,the accuracy,matrix effects and commutability of the reference materials were studied.Results:The result of 4 reference materials and 21 fresh human serum samples displayed difference in accuracy and matrix effect including reference methods and conventional methods.Three reference materials cannot ensure that the results within the range of target value± uncertainty from reference methods,the deviation of GBW09170 and GBW09171 increased in the conventional methods,GBW09171 also showed matrix effects.Conclusion:Clinical applicability should be fully considered in the development process of biochemical and immunological standard reference materials.When reference methods are used to produce biochemical and immunological reference materials,such as creatinine in this evaluation,attention should be paid to the difference of different reference methods,and joint assignments should be considered.At the same time,the commutability among different methods should be fully considered to ensure the accurate transfer of quantitative values as for optimization of produced path,supporting precision medicine.
isotope dilutionliquid phase tandem mass spectrometrysarcosine oxidasemetrological traceabilitystandard reference materialmatrix effect
NETL
NSTL
万方数据
维普
