无偿献血者HBsAg ELISA检测阳性反应标本的确认情况

Confirmation of HBsAg-positive blood donors by ELISA

目的:探讨献血者HBsAg ELISA阳性反应标本的中和确认实验情况,并比较两种ELISA试剂检测献血者HBsAg的效果。方法:采用两种试剂(ELISA方法)对无偿献血者标本检测HBsAg,对Murex HBsAg Version 3试剂阳性反应的标本采用雅培Murex HBsAg中和试剂进行确认。结果:在119724例标本中HBsAg阳性反应为445例,阳性率为0.37%;双试剂阳性反应为274例,阳性率为0.23%。390例Murex HBsAg Version 3试剂阳性反应标本经确认334例阳性(85.64%)、42例不确定(10.77%)、14例阴性(3.59%)。274例双试剂阳性反应经确认后273例阳性(99.3%);在Murex HBsAg Version 3试剂中230例标本S/Co值≥6.1经确认后均为阳性。结论:无偿献血者标本HBsAg检测存在一定比例的假阳性率,一定程度上造成了血液的浪费,双试剂检测呈现阳性反应可以作为一种替代确认策略。

Objective： To confirm the HBsAg positive samples of blood donors by ELISA, and compare the effects of two different ELISA reagents in HBsAg screening among blood donors. Methods ： The samples of blood do- nors were detected by two different ELISA reagents, and the positive samples with Murex HBsAg Version 3 reagent were confirmed with Murex HBsAg neutralization test. Results： Totally 445 samples were found positive among 119724 samples from blood donors（ 0.37% ）, in which 274 samples were found positive by both two different rea- gents（0.23% ）, and 273 cases were confirmed positive （99.3 % ）. Three hundred and ninety samples were positive by Murex HBsAg Version 3 reagent, including 334 confirmed positive cases （ 85. 64% ）, 42 uncertain cases （10.77%） and 14 negative cases（3.59% ） by confirmatory test, in which 230 samples with S/Co~〉6.1 were con- firmed positive at last. Conclusion： ELISA reagent detection may exhibit false positive in HBsAg screening among blood donors, resulting in a waste of the blood resource. So HBsAg screening by two different ELIA reagents can be taken as an alternative positive confirmation protocol.