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The p53 tumor suppressor gene encodes a 53-kDa nuclear phosphoprotein that is thought to protect cells against the accumulation of genetic alterations (1). The p53 phosphoprotein is involved in cycle arrest, apoptosis, inhibition of tumor growth, and preservation of genetic stability (2). Abnormalities of the p53 gene are reported to be the most common genetic alterations in human cancer (3)(4). Mutated p53 gene encodes for mutant p53 proteins that may serve as targets of the host immune system as tumor-specific antigens (5). However, accumulation of the p53 protein in the cell is considered the main cause of anti-p53 antibody production (6). The presence of anti-p53 antibodies has been demonstrated in sera of patients with various cancers (7)(8)(9), including lung (10), breast (11)(12), liver (13), colorectal (14), and prostate cancer, and blood cell malignancies (15).Anti-p53 antibodies initially were detected by immunoblot and immunoprecipitation with extracts of transformed cells as a source of antigen. In recent years, various ELISAs have been described that use mutant (8) or wild-type (16) p53 as antigen, solid-phase or sandwich methods, and prokaryotically or eukaryotically expressed p53 proteins.Our purpose was to evaluate the potential of the tests to provide correct diagnostic classification (17). We studied three commercial ELISAs for anti-p53 antibodies by use of ROC curve analysis. We selected 72 patients presenting with suspicion of malignancy (unexplained body weight loss and chronic fatigue associated with chronic rectal hemorrhage and/or intermittent obstipation, hemoptysis, and/or pathognomonic aspect of tumoral development on chest radiographs). Ethics approval by the Ethics Commission of the University of Dresden (Germany) according to the Helsinki Declaration of 1975 as revised in 1996 as well as informed consent from the study subjects was obtained. Blood samples from patients with suspicion of lung cancer and/or other …

Comparison of the Diagnostic Accuracy of Three Commercially Available Enzyme Immunoassays for Anti-p53 Antibodies