六种检测人类免疫缺陷病毒抗体的酶免疫测定法的评估

Evaluation of six enzyme immunoassays for antibody against human immunodeficiency virus.

作者信息

Reesink H W, Lelie P N, Huisman J G, Schaasberg W, Gonsalves M, Aaij C, Winkel I N, van der Does J A, Hekker A C, Desmyter J

出版信息

Lancet. 1986 Aug 30;2(8505):483-6. doi: 10.1016/s0140-6736(86)90358-2.

DOI:10.1016/s0140-6736(86)90358-2

PMID:2875239

Abstract

Six commercial enzyme immunoassays (EIA) were evaluated in 6488 serum samples, with immunoblot analysis as the confirmatory test for antibodies against human immunodeficiency virus (HIV). The Abbott and Wellcome tests identified all 163 immunoblot-positive samples correctly, whereas the other tests did not detect 1-3 samples. In AIDS patients (predominantly with antibodies to gp41env) Organon's EIA was less sensitive (p less than 0.05) and Wellcome's more sensitive (p less than 0.05) than the immunoblot assay. In symptom-free anti-HIV-positive subjects (antibodies to almost all viral antigens and high titres of anti-p24gag) all the EIA were significantly (p less than 0.05) less sensitive than the immunoblot assay. The frequencies of false-positive reactions in a "tricky" panel of samples from patients with autoimmune and acute viral diseases and in a blood-donor panel were Abbott 9.5%, 0.42%: Organon 1.7%, 0%; Litton 1.0%, 0.4%; Behring 2.7%, 0.06%; Wellcome 0%, 0%; and Pasteur 0%, 0.02%. The results of a seventh EIA (Dupont) were excluded from the study at the company's request. All six EIA evaluated are suitable tests for anti-HIV screening in samples from patients and blood donors.

摘要

对6488份血清样本中的6种商用酶免疫测定法（EIA）进行了评估，以免疫印迹分析作为抗人类免疫缺陷病毒（HIV）抗体的确证试验。雅培和威康检测法正确识别了所有163份免疫印迹阳性样本，而其他检测法未检测出1 - 3份样本。在艾滋病患者中（主要是针对gp41env的抗体），欧加农的EIA比免疫印迹测定法敏感性更低（p < 0.05），而威康的则更敏感（p < 0.05）。在无症状的抗HIV阳性受试者中（针对几乎所有病毒抗原的抗体以及高滴度的抗p24gag抗体），所有的EIA均比免疫印迹测定法敏感性显著更低（p < 0.05）。在来自自身免疫性疾病和急性病毒性疾病患者的一组“棘手”样本以及献血者样本中，雅培的假阳性反应频率分别为9.5%、0.42%；欧加农为1.7%、0%；利顿为1.0%、0.4%；贝林为2.7%、0.06%；威康为0%、0%；巴斯德为0%、0.02%。应公司要求，第七种EIA（杜邦）的结果被排除在研究之外。所评估的所有六种EIA均适用于对患者和献血者样本进行抗HIV筛查。