Nair B C, Ford G, Kalyanaraman V S, Zafari M, Fang C, Sarngadharan M G
Advanced BioScience Laboratories, Inc., Kensington, Maryland 20895.
J Clin Microbiol. 1994 Jun;32(6):1449-56. doi: 10.1128/jcm.32.6.1449-1456.1994.
An enzyme immunoassay using the purified native gp160 for the detection of human immunodeficiency virus type 1 (HIV-1) antibody was developed. This assay was determined to be highly specific, since (i) 157 serum samples that were confirmed negative by Western blot (immunoblot) (WB) were negative, (ii) 41 serum samples from populations with medical conditions that might cause nonspecific assay reactivity were all negative, and (iii) all 15 serum samples that showed false-positive reactions in one or more commercial HIV-1 screening tests were negative. The assay gave 100% specificity with a randomly selected and unlinked panel of 1,000 serum samples from healthy blood donors. The sensitivity of the assay was assessed by testing 238 samples confirmed as HIV-1 antibody positive by a standardized WB assay. All 238 serum samples (100%) were reactive in the native gp160 assay. In a dilution panel of 14 weakly WB-positive serum samples, 7 samples reacted two-to fivefold more strongly in the gp160 assay than in a virus lysate-based assay; the remaining 7 samples gave comparable reactivities in the two tests. The reactivities of 13 of these 14 serum samples in the gp160 assay were higher than in a commercial enzyme immunoassay that uses a recombinant envelope protein as the antigen. The native gp160 assay was more sensitive to identify seroconversion. In a well-characterized panel of sequential blood samples from a seroconverter, the new assay detected antibodies at least one sample ahead of the other commercial assays tested.
开发了一种使用纯化的天然糖蛋白160（gp160）检测1型人类免疫缺陷病毒（HIV-1）抗体的酶免疫测定法。该测定法被确定具有高度特异性，原因如下：（i）157份经蛋白质印迹法（免疫印迹法，WB）确认为阴性的血清样本在此测定中呈阴性；（ii）41份来自可能导致非特异性测定反应性的疾病人群的血清样本均为阴性；（iii）在一项或多项商用HIV-1筛查试验中出现假阳性反应的所有15份血清样本在此测定中均为阴性。对于从健康献血者中随机选取且无关联的1000份血清样本组成的样本组，该测定法的特异性为100%。通过检测238份经标准化WB测定法确认为HIV-1抗体阳性的样本评估该测定法的灵敏度。所有238份血清样本（100%）在天然gp160测定中呈反应性。在由14份WB弱阳性血清样本组成的稀释样本组中，7份样本在gp160测定中的反应强度比基于病毒裂解物的测定法高两到五倍；其余7份样本在两种检测中的反应性相当。这14份血清样本中的13份在gp160测定中的反应性高于使用重组包膜蛋白作为抗原的商用酶免疫测定法。天然gp160测定法在识别血清转化方面更敏感。在一名血清转化者的一组特征明确的连续血样中，新测定法比所测试的其他商用测定法至少提前一个样本检测到抗体。
