Highly specific urine-based marker of bladder cancer

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 urin...

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Bibliographic Details
Published in:Urology (Ridgewood, N.J.) N.J.), 2005-12, Vol.66 (6), p.1256-1260
Main Authors: VAN LE, Thu-Suong, MILLER, Raymond, BARDER, Timothy, BABJUK, Marko, POTTER, Douglas M, GETZENBERG, Robert H
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Biological and medical sciences
Biomarkers, Tumor - urine
Female
Humans
Immunoassay - methods
Male
Medical sciences
Middle Aged
Nephrology. Urinary tract diseases
Nuclear Proteins - urine
Sensitivity and Specificity
Tumors of the urinary system
Urinary Bladder Neoplasms - urine
Urinary system involvement in other diseases. Miscellaneous
Urinary tract. Prostate gland
Urologic Diseases - urine
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Summary: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.
ISSN:0090-4295
1527-9995
DOI:10.1016/j.urology.2005.07.010