Van Le Thu-Suong, Miller Raymond, Barder Timothy, Babjuk Marko, Potter Douglas M, Getzenberg Robert H
Department of Urology, University of Pittsburgh, Cancer Institute, Pittsburgh, Pennsylvania, USA.
Urology. 2005 Dec;66(6):1256-60. doi: 10.1016/j.urology.2005.07.010.
Bladder cancer represents a major health problem throughout the world, but advances in tumor biomarker development are revolutionizing how physicians diagnose the disease. We previously used an indirect immunoassay to demonstrate that the bladder cancer specific biomarker, BLCA-4, is present in urine samples from patients with bladder cancer, but not in samples from healthy individuals. In this study, a sandwich immunoassay was used to measure BLCA-4 in urine samples from patient populations with various urologic conditions and healthy individuals.
Urine was collected from healthy individuals and from patients with bladder cancer, benign urologic conditions, or prostate cancer. BLCA-4 levels were evaluated by a sandwich immunoassay using two antibodies directed against distinct epitopes on BLCA-4.
Using a prospectively determined cutoff of an absorbance unit (OD) of 0.04, 67 of the 75 samples from patients with bladder cancer were positive for BLCA-4, resulting in an assay sensitivity of 89%. Also, 62 of the 65 samples from individuals without bladder cancer were negative for BLCA-4, resulting in an assay specificity of 95%.
The high sensitivity and specificity of the sandwich BLCA-4 immunoassay may allow for earlier detection and treatment of disease, thus greatly improving patient care.
膀胱癌是全球范围内的一个主要健康问题，但肿瘤生物标志物开发方面的进展正在彻底改变医生诊断该疾病的方式。我们之前使用间接免疫测定法证明，膀胱癌特异性生物标志物BLCA-4存在于膀胱癌患者的尿液样本中，而不存在于健康个体的样本中。在本研究中，我们使用夹心免疫测定法来测量患有各种泌尿系统疾病的患者群体以及健康个体尿液样本中的BLCA-4。
收集健康个体以及膀胱癌、良性泌尿系统疾病或前列腺癌患者的尿液。使用针对BLCA-4上不同表位的两种抗体，通过夹心免疫测定法评估BLCA-4水平。
采用预先确定的吸光度单位（OD）为0.04的临界值，75例膀胱癌患者样本中有67例BLCA-4呈阳性，检测灵敏度为89%。此外，65例非膀胱癌个体样本中有62例BLCA-4呈阴性，检测特异性为95%。
BLCA-4夹心免疫测定法的高灵敏度和特异性可能有助于疾病的早期检测和治疗，从而极大地改善患者护理。
