Oelemann Walter M R, Lowndes Catherine M, Veríssimo Da Costa Giovani C, Morgado Mariza G, Castello-Branco Luiz Roberto R, Grinsztejn Beatriz, Alary Michel, Bastos Francisco I
Depto. de Imunologia, Instituto de Microbiologia, Universidade Federal do Rio de Janeiro, Cidade Universitária, 21941-590 Rio de Janeiro, Brazil.
J Clin Microbiol. 2002 Mar;40(3):881-5. doi: 10.1128/JCM.40.3.881-885.2002.
We evaluated, for the first time in Latin America, the performance of a commercial enzyme immunoassay (EIA) (Calypte Biomedical Corporation, Berkeley, Calif.) that detects human immunodeficiency virus type 1 (HIV-1)-specific antibodies in urine in comparison to standard serological assays (two commercial EIAs and a commercial Western blot [WB] assay). Paired serum and urine specimens were collected from two different groups of Brazilian patients: 225 drug users with unknown HIV status who attended drug treatment centers in Rio de Janeiro, Brazil, and 135 subjects with known HIV status. Patients showing positive results in the serum EIAs and/or in the urine EIA were serologically confirmed by WB assay. For 135 individuals with known HIV status, the urine EIA showed 100% sensitivity (74 positive samples) and 95.1% specificity (58 of 61 negative specimens). For 225 drug users, the test showed 100% sensitivity (2 positive samples) and 98.7% specificity (220 of 223 negative samples) compared to WB-confirmed serological EIA results. Thus, in a total of 360 samples, the urine EIA correctly identified all 76 HIV-positive samples and 278 of 284 negative samples (100% sensitivity and 97.9% specificity). Detailed analysis of the urine EIA results indicates that an increase of the recommended cutoff value might raise the specificity of the assay without affecting its sensitivity. Our results suggest that the HIV-1 urine EIA is a good screening test suitable for developing countries like Brazil. However, as for all other HIV screening tests on the market, it is not specific enough to be used as a one-step test and therefore requires confirmation.
我们在拉丁美洲首次评估了一种商用酶免疫测定法（EIA）（加利福尼亚州伯克利市的卡利普特生物医学公司）检测尿液中人类免疫缺陷病毒1型（HIV-1）特异性抗体的性能，并与标准血清学检测方法（两种商用EIA和一种商用免疫印迹法[WB]）进行了比较。从两组不同的巴西患者中收集了配对的血清和尿液样本：225名HIV感染状况不明的吸毒者，他们在巴西里约热内卢的戒毒治疗中心接受治疗；以及135名已知HIV感染状况的受试者。血清EIA和/或尿液EIA检测结果呈阳性的患者通过WB检测进行血清学确认。对于135名已知HIV感染状况的个体，尿液EIA显示出100%的灵敏度（74个阳性样本）和95.1%的特异性（61个阴性样本中的58个）。对于225名吸毒者，与WB确认的血清学EIA结果相比，该检测显示出100%的灵敏度（2个阳性样本）和98.7%的特异性（223个阴性样本中的220个）。因此，在总共360个样本中，尿液EIA正确识别了所有7`6个HIV阳性样本和284个阴性样本中的278个（100%的灵敏度和97.9%的特异性）。对尿液EIA结果的详细分析表明，提高推荐的临界值可能会提高检测的特异性而不影响其灵敏度。我们的结果表明，HIV-1尿液EIA是一种适用于巴西等发展中国家的良好筛查检测方法。然而，与市场上所有其他HIV筛查检测一样，它的特异性不足以作为一步检测方法使用，因此需要进行确认。
