Urnovitz H B, Sturge J C, Gottfried T D
Calypte Biomedical, California 94710, USA.
Nat Med. 1997 Nov;3(11):1258. doi: 10.1038/nm1197-1258.
Clinical trial results from 11,344 paired urine and serum samples revealed 1,181 HIV-1-positive individuals confirmed by western blot (WB). There were 25 discrepant samples: 10 were urine enzyme immunoassay (EIA) and WB positive, serum non-reactive and serum WB negative or indeterminate, and 15 were serum EIA and WB positive, urine EIA non-reactive or urine WB negative or indeterminate. Serum samples, HIV-1 antibody WB confirmed, revealed a 99.15% sensitivity (1,171 out of 1,181); urine samples, HIV-1 antibody WB confirmed, showed a 98.73% sensitivity (1,166 out of 1,181). This study demonstrated that neither serum nor urine results alone are as sensitive for HIV-1 antibody detection as combined results of both samples.
来自11344对尿液和血清样本的临床试验结果显示，经蛋白质印迹法（WB）确认有1181例HIV-1阳性个体。有25个样本结果不一致：10个样本尿液酶免疫测定（EIA）和WB呈阳性，血清无反应且血清WB为阴性或不确定；15个样本血清EIA和WB呈阳性，尿液EIA无反应或尿液WB为阴性或不确定。经HIV-1抗体WB确认的血清样本显示敏感性为99.15%（1181例中的1171例）；经HIV-1抗体WB确认的尿液样本显示敏感性为98.73%（1181例中的1166例）。这项研究表明，单独的血清或尿液检测结果对于HIV-1抗体检测的敏感性均不如两种样本的联合检测结果。
