McCabe R P, Lamm D L, Haspel M V, Pomato N, Smith K O, Thompson E, Hanna M G
Cancer Res. 1984 Dec;44(12 Pt 1):5886-93.
An enzyme-linked immunosorbent assay (ELISA) using a monoclonal antibody was developed to determine the clinical value of urinary fibrinogen/fibrin degradation product levels for the identification and management of patients with bladder cancer. Assays were performed on 286 serial urine specimens from 56 bladder carcinoma patients. Specimens were grouped according to whether the patient had an evident tumor at the time of specimen collection (134 specimens, 41 patients) or was clinically disease-free following treatment (152 specimens, 38 patients). Many patients contributed specimens to both groups as determined by their clinical status at the time of collection. In addition, 45 specimens from 33 patients with inflammation of the urogenital tract and 81 specimens from 19 patients with renal or prostatic cancer were assayed for urinary fibrin degradation products. The ELISA, using a high-sensitivity procedure, identified 83% of the specimens from bladder cancer-positive patients with an overall accuracy with all specimens of 78% and a false-negative rate of 5% for all specimens tested. The high-sensitivity ELISA appeared most appropriate for monitoring bladder cancer patients for recurrence of tumor after surgery. The ELISA using a high-specificity procedure appeared most appropriate for screening. The high-specificity ELISA accurately identified 96% of urine specimens from non-bladder cancer patients with a false-positive rate of only 5%. These results demonstrate that the ELISA is an efficient, reliable, quantitative, and noninvasive immunoassay that can be useful both for the identification of bladder cancer patients and for monitoring the course of the disease.
开发了一种使用单克隆抗体的酶联免疫吸附测定（ELISA）方法，以确定尿纤维蛋白原/纤维蛋白降解产物水平在膀胱癌患者识别和管理中的临床价值。对56例膀胱癌患者的286份连续尿液标本进行了检测。标本根据患者在标本采集时是否有明显肿瘤（134份标本，41例患者）或治疗后临床无疾病（152份标本，38例患者）进行分组。许多患者根据采集时的临床状态为两组都提供了标本。此外，还对33例泌尿生殖道炎症患者的45份标本和19例肾癌或前列腺癌患者的81份标本进行了尿纤维蛋白降解产物检测。该ELISA采用高灵敏度程序，在膀胱癌阳性患者的标本中识别出83%，所有标本的总体准确率为78%，所有检测标本的假阴性率为5%。高灵敏度ELISA似乎最适合监测膀胱癌患者术后肿瘤的复发情况。采用高特异性程序的ELISA似乎最适合筛查。高特异性ELISA准确识别出96%的非膀胱癌患者的尿液标本，假阳性率仅为5%。这些结果表明，ELISA是一种高效、可靠、定量且非侵入性的免疫测定方法，可用于识别膀胱癌患者和监测疾病进程。
