Establishment and Traceability Study of Cystatin C Frozen Human Serum National Standard
Objective:To carry out a quantitative traceability study on cystatin C,and to develop cystatin C frozen human serum national standard,which can be used for evaluating the accuracy of cystatin C test kits,and improving the ability of human serum cystatin C detection.Methods:Human serum samples were used as raw materials for aseptic sub-packaging and preparation of cystatin C frozen human serum national standard.The candidate of cystatin C frozen human serum national standard was assigned and calibrated by the method of multi-laboratory joint assignment,which was traceable to the international standard ERM-DA471/IFCC,and the accuracy of the traceability chain has been verified.The homogeneity and stability of the national standard was verified by the method of immune turbidimetry.Results:The cystatin C frozen human serum national standard was established,which contains two concentration levels:level 1(0.94±0.03)mg·L-1(k=2),Level 2(3.52±0.09)mg·L-1(k=2);cystatin C frozen human serum national standard has good homogeneity and stability.The results of the 30-day short-term stability study showed that cystatin C frozen human serum national standard(level 1 and level 2)were stable for 5 days at room temperature;at 2-8 ℃,level 1 can be stable for 10 days and level 2 can be stable for 20 days.At-20 ℃,both level 1 and level 2 can be stable for at least 30 days.The accuracy of the traceability was verified by using the serum reference panel and clinical serum samples,study results show that the national standard and international standard ERM-DA471/IFCC have good traceability.Conclusion:The Cystatin C frozen human serum national standard(360046-202001)has been approved and provided to the society with the quantitative traceability study,which can be used for the accuracy evaluation of the cystatin C detection kit in human serum and the accuracy evaluation of clinical laboratory detection system values.
Cystatin Cquantity traceabilityinternational standard materialimmunoturbidimetry
NETL
NSTL
万方数据
维普
