Establish and confirm of blood donor deferral criterion in HBsAg ELISA test / 国际检验医学杂志

ABSTRACT

Objective To establish and confirm the hepatitis B surface antigen(HBsAg) enzyme linked immunosorbent assay(ELISA) high specificity S/CO limit as blood donor deferral criterion.Methods A total of 783 HBsAg ELISA reactive and 588 non-reactive samples were collected, and confirmed by HBsAg electrochemiluminescence detection and neutralization test.Receiver operating characteristic curve (ROC curve) was used to evaluate the S/CO limit under 95% and 99% specificity.Another 124 HBsAg ELSIA reactive samples were tested for five kinds of hepatitis B virus(HBV) markers by using electrochemiluminescence detection to verify the blood donor deferral limit.The blood donor deferral limits of 3 laboratories, using the same reagents, were compared.Results The 95% specificity S/CO limit of two reagents were 0.24 and 0.65, the 99% specificity S/CO limit of two reagents were 3.89 and 3.62.The 99% specificity S/CO limit was set as the blood donor deferral criterion.Verify test indicated that the samples, with S/CO higher than the blood donor reentry limit of reagent 1 and 2, were all from HBV infected donor.The 99% specificity S/CO limits of reagent 1 in the other three laboratories were 3.77, 3.60 and 13.42 respectively.And the 99% specificity S/CO limits of reagent 2 in the other three laboratories were 27.73, 31.75 and 1.17.Conclusion The blood donor deferral limit of HBsAg ELISA could identify the true positive blood donor, and reduce the number of blood donor, entering the reentry process.It might not suit to adopt a unified donor deferral limit in different laboratories, even using the same reagents.