献血者HBsAg ELISA检测屏蔽界限值研究

目的建立酶联免疫吸附法(ELISA)对献血者进行乙肝表面抗原(HBsAg)检测的高特异性S/CO屏蔽界限值。方法对783份HBsAg ELISA反应性标本和588份非反应标本,采用HBsAg化学发光法和中和实验确认检测。根据确认检测结果和ELISA检测S/CO值建立受试者工作特征曲线(ROC曲线),确定95%和99%特异度对应的S/CO界限值。另选择124份HBsAg ELISA反应性标本对设定的屏蔽界限值进行验证,同时以乙肝五项化学发光发检测结果作为补充,判断屏蔽界限值的实用性。比较不同实验室采用相同试剂设定的99%特异度对应的HBsAg ELISA检测S/CO界限值。结果该实验室采用的2种ELISA试剂95%特异度对应的S/CO界限值分别为0.24和0.65,99%特异度对应的S/CO界限值分别为3.89和3.62,将99%特异度对应的S/CO界限值设定为该实验室献血者屏蔽界限值。验证实验证实,大于或等于试剂1和试剂2屏蔽界限值的标本均为HBV感染标本。与该实验室采用相同HBsAg ELISA检测试剂的3家实验室,试剂1的99%特异度对应S/CO界限值分别为3.77、3.60、13.42,试剂2分别为27.73、31.75、1.17。结论该研究建立的献血者HBsAg ELISA检测屏蔽界限值可在该实验室有效甄别出真阳性献血者,有助于减少进入归队流程的献血者数量。即使采用相同的ELISA检测试剂,不同实验室也不适用统一的献血者屏蔽界限值。

Establish and confirm of blood donor deferral criterion in HBsAg ELISA test

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.