Paper
Determination of Prostate Specific Antigen in Human Serum Using Biochip–Based Test System Results of Clinical Trials
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Authors:
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Tatiana V. Osipova; Tatiana P. Ryabykh; Zinaida A. Sokolova; Valentina I. Karaseva; Nikolay B. Paklin
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Abstract
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Prostate specific antigen (PSA) is the main marker of prostate cancer (PCa). Two forms of the antigen, the total and the free (PSAt and PSAf), and their ratio are used in the diagnosis and monitoring of patients with PCa. Modern biochip technology allows to create new, improved diagnostic systems for determining tumor markers. The aim of the study was to assess the diagnostic efficacy of a new test system in a microchip format (EIMB RAS) to define two forms of PSA in human serum. On a large clinical material including 164 samples of blood serum of cancer, non-cancer patients and healthy donors, we have shown that the test system in a microchip format allows a simultaneous quantitation of PSAt and PSAf and makes it possible to obtain results that are comparable with the results of conventional ELISA test systems. Using logistic regression models and ROC-analysis showed that the new test system in a microchip format had the diagnostic efficacy comparable with the efficiency of the widely used ELISA test systems Fujirebio Diagnostics (Sweden), and in some cases surpassed the last in terms of specificity (PSAt and %PSAf). The values of the areas under the ROC-curves (AUCs) when used multifactor models are 0.725 for the system in a microchip format, and 0.642 for ELISA test kits Fujirebio Diagnostics.
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Keywords
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Protein Microchip; Diagnostic Test Systems; Prostate Cancer; Prostate Specific Antigen; ROC-analysis
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StartPage
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127
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EndPage
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133
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Doi
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