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目的:分析无偿献血者乙型肝炎病毒表面抗原(HBsAg)不合格标本的中和确证试验结果,以保证血液安全和减少血液浪费。方法:收集河北省血液中心359例HBsAg不合格标本,采用中和试验法对配套HBsAg诊断试剂盒(酶联免疫法)检测结果呈重复阳性的标本进行确证试验。结果:359例不合格血液标本经中和试验法确证187例阳性,172例阴性,ELISA法假阳性率为47.91%;初次双试剂反应性标本S/CO均>5,其阳性符合率100%;当S/CO于1~5之间,其阳性符合率为65.63%;在确证为阳性的标本中,183例呈ELISA双试剂反应性,3例呈ELISA单试剂反应性,1例ELISA检测结果处于灰区值。结论:无偿献血者HBsAg ELISA筛查试验存在部分假阳性的问题,为减少血源流失,保证血液安全,可考虑对不合格标本进行确证试验,同时有必要设置合理的灰区范围。
OBJECTIVE: To analyze the results of the neutralization confirmatory test of unqualified samples of hepatitis B virus surface antigen (HBsAg) in non-profit blood donors to ensure blood safety and reduce blood waste. Methods: 359 HBsAg non-conforming samples were collected from blood center of Hebei Province. The neutralization test was used to confirm the positive samples of HBsAg diagnostic kit (enzyme-linked immunosorbent assay). Results: Of the 359 unqualified blood samples, 187 were confirmed positive by neutralization test and 172 were negative. The false positive rate of ELISA was 47.91%. The S / CO of the first double reagent reactivity specimens was> 5, the positive coincidence rate was 100% ; When the S / CO was between 1 and 5, the positive coincidence rate was 65.63%. Among the positive samples, 183 were reactive with ELISA, 3 were single-ELISA reactivity and 1 was ELISA The result is in the gray zone value. Conclusion: There is a partial false positive for HBsAg ELISA screening test in unpaid blood donors. In order to reduce blood loss and ensure blood safety, confirmatory tests of unqualified samples may be considered, and it is necessary to set a reasonable range of gray areas.