Yoshihara N, Shimada H, Yamazaki O, Kimura T, Oka S, Kumamoto E, Hirose M, Masuda K, Negishi M, Misawa A
AIDS Research Center, National Institute of Health, Shinjuku-ku, Tokyo.
Rinsho Byori. 1995 Mar;43(3):249-56.
An enzyme immuno assay kit has been developed to detect anti-HIV antibody in urine. In order to examine the clinical utility of the kit, 1333 urine samples were assayed. These samples consisted of 233 urine samples from HIV infected patients, 472 samples from HIV uninfected patients including 203 samples from patients with urogenital diseases, and 628 samples from normal subjects. Anti-HIV antibodies were detected in all the urine samples from HIV infected patients, and the diagnostic sensitivity for HIV infection was 100% with no false negative cases. A variety of anti-HIV antibody titers were found in the urine samples from HIV infected patients. However, no significant differences were found in the distribution patterns of urinary anti-HIV antibody titers among AC, ARC and AIDS patients. False positives were determined in only five samples in 628 healthy subjects (0.8%), one in 19 patients with hepatitis (5.3%), one in 45 patients with hemophilia (2.2%) and two in 105 pregnant women (1.9%). The antibody titers of all the false positive samples in these groups were less than the cut-off index multiplied by two. However, relatively high positive rates were demonstrated in the samples from urogenital diseases (11.8%), diabetes mellitus (20.0%) and auto-immune diseases (7.3%). False positive results were found to be directly correlated to the protein concentration of urinary protein, especially the immunoglobulin concentration in urine. The assay system was also evaluated by various reproducibility tests performed by different operators at different laboratories. The test results were satisfactory.(ABSTRACT TRUNCATED AT 250 WORDS)
已开发出一种酶免疫测定试剂盒，用于检测尿液中的抗HIV抗体。为了检验该试剂盒的临床效用，对1333份尿液样本进行了检测。这些样本包括233份来自HIV感染患者的尿液样本、472份来自未感染HIV患者的样本（其中包括203份来自泌尿生殖系统疾病患者的样本）以及628份来自正常受试者的样本。在所有HIV感染患者的尿液样本中均检测到了抗HIV抗体，对HIV感染的诊断敏感性为100%，无假阴性病例。在HIV感染患者的尿液样本中发现了多种抗HIV抗体滴度。然而，在艾滋病相关综合征（AC）、艾滋病相关征候群（ARC）和艾滋病患者中，尿液抗HIV抗体滴度的分布模式未发现显著差异。在628名健康受试者中仅有5份样本出现假阳性（0.8%），在19名肝炎患者中有1份（5.3%），在45名血友病患者中有1份（2.2%），在105名孕妇中有2份（1.9%）。这些组中所有假阳性样本的抗体滴度均低于临界指数乘以二。然而，在泌尿生殖系统疾病患者的样本（11.8%）、糖尿病患者的样本（20.0%）和自身免疫性疾病患者的样本（7.3%）中显示出相对较高的阳性率。发现假阳性结果与尿蛋白浓度直接相关，尤其是尿液中的免疫球蛋白浓度。不同实验室的不同操作人员通过各种重复性试验对该检测系统进行了评估。测试结果令人满意。（摘要截取自250字）
