Abstract:

Objective To establish the national standard materials of testosterone in frozen human serum,to evaluate the accuracy,and to promote the standardization of testosterone assay. Methods Serum samples without lipemia,hemolysis and jaundice were collected. After multiple filtration sterilization,serum pools were packed into ampoules in 2-level candidate materials and were stored in -70 ℃. The homogeneity for candidate material was evaluated by single factor analysis of variance,and the stability was evaluated by linear regression analysis. The values of candidate material were assigned by reference method,and the uncertainty was calculated. The commutability was evaluated. Results The F values of homogeneity for candidate material level Ⅰ and level Ⅱ were 1.448 5 and 1.569 6,respectively. All of them were <F_0.05. The stabilities of level Ⅰ and level Ⅱ can be last at least 30 d at -20 ℃. The assigned values of level Ⅰ and level Ⅱ were（0.22±0.05）ng/mL（k=2） and （3.67±0.16）ng/mL （k=2）,respectively. The values were all within 95% confidence interval,which showed that the commutability was good. Conclusions The homogeneity,stability and commutability of candidate material are good,and their values are assigned accurately and reliably. They can be used as national standard.

Key words: Testosterone, Frozen human serum, National standard