Определение простатического специфического антигена в сыворотке крови человека с помощью тест-системы в формате биочипа: результаты клинических испытаний

PSA is the most useful indicator of PCa. Two forms of this antigen, tPSA, fPSA, and their ratio (%fPSA) are used in diagnostics and monitoring of patients with PCa. Modern biochip technology makes it possible to develop more perfect diagnostic systems for detection of tumors’ markers. The goal of the investigation is diagnostic performance evaluation of the biochip-based test system (EIMB, RAS) for simultaneous detection of two PSA forms in human serum. Sera were collected from 164 patients with PCa, non-malignant prostate diseases and healthy donors. Here we show, that the biochip-based test system makes it possible simultaneous quantitation of tPSA and fPSA, and the tumor marker levels obtained are highly competative with these derived from conventional ELISA test systems (Fujirebio Diagnostics, Sweden). ROC-analysis and logistic regression analysis were used to compare the diagnostic accuracy of two systems. The new test system has diagnostic effeciency competative with that of ELISA systems, and is superior to the latter in specificity for tPSA and %fPSA. AUCs the ROC-curves in multifactorial models are 0,725 for biochip-based test-system and 0,642 for ELISA systems.