Objective:To validate the method for the determination of anti-HBS titer of human tetanus immunoglobulin by ELISA.Methods:According to the validation guidelines of 9401 biological activity/titer determination method of biological products in Chinese Pharmacopoeia(2020 edition),the specificity,relative accuracy,intermediate precision,linear and linear range of human tetanus immunoglobulin anti-HBS assay(ELISA)method are verified.The results are compared with those of radioimmunoassay(RIA).Results:In the specific verification,the recoveries are between 88%and 110%,the theoretical and measured results are equivalent,and the samples and mixed samples are parallel to the standard regression curve;in the verification of relative accuracy,relative bias ranges from-6.9%to 5.0%,and the slope of regression curve is 0.998 1;in intermediate precision verification,geometric coefficient of variation are all＜10%;in linear verification,the correlation coefficient of regression curve is 0.997 0;method range is 10 mIU/mL to 120 mIU/mL.The average value of anti-HBS 6 times per 1 g of protein measured by ELISA is 0.5 IU lower than that by RIA.Conclusion:It is proved that ELISA can replace RIA for the determination of anti-HBS titer in human tetanus immunoglobulin.
assay of anti-HBsELISAhuman tetanus immunoglobulin
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