ELISA法抗HIV检测设置灰区的意义分析

Analysis of anti-HIV detection result and the setting of grey zone by ELISA

目的:探讨ELISA法在无偿献血者HIV抗体检测中设置灰区的必要性,为临床血液检测提供依据。方法:选择179例ELISA法抗HIV检测灰区阳性的无偿献血标本,统计学分析献血者的人群特征、WB确证结果和部分标本的NAT检测结果,以及3种检测结果之间的关系。结果:ELISA初筛灰区阳性的179例标本,经WB验证后确认178例为阴性,1例为不确定,其条带为gp160,后期随访结果转为阳性;37例灰区标本通过NAT检测,发现1例为阳性。两种方法验证为阳性的标本非同一献血者。结论:ELISA法HIV检测灰区阳性一方面可以避免漏检,降低经输血传播艾滋病而造成严重社会不良事件的概率,但另一方面,也可导致血液资源的浪费。

Objective：To explore the necessity of establishing grey zone in the detection of HIV antibody by ELISA,and to provide evidence for clinical blood test.Methods：The relationship between the test results of Western Blottest and Nucleic acid amplification test of179 volunteer donors′samples which were reactive to anti-HIV reagents（ELISA,grey zone）were statistically analyzed.All the volunteer donors′samples were collectted in the Lanzhou blood center of the PLA during 2011-2016.Results：A total of 179 specimens were detected by WB and 1 specimens was uncertainty,the band was gp160,and later follow-up found that the results was positive.37 specimens were detected by NAT and 1 specimens were positive,and the results of these two methods indicate that the positive specimen is not the same blood donor.Conclusion：There are two meanings in establishing grey zone in the detection of HIV antibody by ELISA.On the one hand,it can avoid leakage and reduce the probability of serious social adverseevents caused by the transmission of AIDS through blood transfusion,on the other hand,it also causes the waste of valuable blood resources due to human factors.