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目的了解进口与国产2类酶联免疫(ELISA)试剂的检测情况,探讨与免疫印迹试验(WB)的关系。方法收集本实验室2006—2008年常规HIV抗体ELISA试验和WB试验的检测数据,比较进口与国产ELISA试剂的检测结果、S/CO值的差别,依据ELISA试验检测结果及S/CO值变化情况分析与WB结果及带型的关系。结果3 870例标本经进口和国产ELISA试剂联合筛查检测,出现“进口+/国产-”和“进口-/国产+”的一阴一阳结果分别为162、127例,双阳结果3 581例,3种筛查结果经WB确证为阳性、不确定、阴性的比例分别为0.62%(1/162)、35.8%(58/162)、63.58%(103/162),0(0/127)、42.52%(54/127)、57.48%(73/127),96.43%(3 453/3 581)、2.79%(100/3 581)、0.78%(28/3 581);进口、国产ELISA试剂检测结果S/CO值处于1～6之间的标本,WB确证为阳性、不确定、阴性的比例分别为9.50%、42.53%、47.96%和34.70%、33.96%、31.34%,S/CO值≥6的标本,其相应的比例分别为97.47%、1.82%、0.74%和97.65%、1.83%、0.52%。2类试剂WB试验阳性、不确定、阴性3种确证结果之间S/CO值差异均有统计学意义(P<0.05)。结论尽管现行HIV抗体ELISA、WB检测技术已经可以很大程度区分阳性和阴性标本,但仍存在不足之处。为达到《全国艾滋病检测技术规范》所要求的最大限度确保检测结果及时、准确和正确,有必要采取相应的应对措施。
Objective To understand the detection of imported and domestic two types of enzyme-linked immunosorbent (ELISA) reagents and to explore the relationship with Western blotting (WB). Methods The data of ELISA test and WB test of routine HIV antibody in our laboratory from 2006 to 2008 were collected. The differences of S / CO value between imported and domestic ELISA reagents were compared. The results of ELISA test and the change of S / CO value Analysis and WB results and the relationship between the type. Results A total of 3 870 specimens were detected by the combination of imported and domestic ELISA reagents. The results of one yin and yang with “Import + / Domestic- ” and “Import + / Domestic + ” were 162,127 and Results A total of 3 581 cases were screened and the results of three screening tests were confirmed as positive, with uncertain and negative rates of 0.62% (1/162), 35.8% (58/162), 63.58% (103/162), 0 ( 0/127), 42.52% (54/127), 57.48% (73/127), 96.43% (3 453/3 581), 2.79% (100/3 581), 0.78% (28/3 581) , The results of domestic ELISA reagent S / CO values between 1 and 6 specimens, WB confirmed as positive, indeterminate, negative ratio were 9.50%, 42.53%, 47.96% and 34.70%, 33.96%, 31.34%, respectively, The corresponding proportions of specimens with S / CO value≥6 were 97.47%, 1.82%, 0.74% and 97.65%, 1.83% and 0.52%, respectively. There were significant differences in S / CO values between the two kinds of reagents WB test positive, indeterminate and negative confirmatory results (P <0.05). Conclusion Although the current HIV antibody ELISA, WB detection techniques have been able to distinguish between positive and negative samples to a large extent, but there are still some shortcomings. In order to achieve the “national AIDS testing technical specifications,” the maximum required to ensure that the test results timely, accurate and correct, it is necessary to take appropriate countermeasures.