Introduction. The measurement of total prostate-specific antigen (PSA) concentration in blood serum is widely used to stratify the severity of prostate cancer, using test systems from different manufacturers. Purpose. To evaluate the possibility of using a test system for enzyme immunoassay of prostate specific antigen (PSA) in blood and for urin. Materials and methods. The validation was performed using the standard addition method. Seven urine samples of men (30.6 ± 5.3 old) were analyzed. A control sample with a known PSA concentration was added to each sample in a ratio of 1:9 (v/v). Statistical analysis was carried out using StatTech v.4.8.11. Results. A high correlation was found between the expected and measured PSA concentrations (? = 0.991; p < 0.001), indicating the absence of matrix effects when using urine as a test material. No hook effect was detected. The differences between expected and measured concentrations were statistically insignificant (p = 0.803). Conclusion. The PSA-ELISA-BEST (T-8458) test system is suitable for determining total PSA not only in blood serum but also in urine. The results formed the basis of Rationalization Proposal No. 2863 (28 February 2024).
Valentina A. Artemyeva – MD, 3rd year postgraduate student specializing in clinical laboratory diagnostics at the Department of Faculty Therapy No. 2, Occupational Pathology and Clinical Laboratory Diagnostics, of the Wagner State Medical University, E. A. Vagner Perm State Medical University, Ministry of Health of Russian Federation, Perm, Russia.
Konstantin R. Gal'kovich – MD, PhD, Candidate of Medical Sciences, Associate Professor, Associate Professor of the Department of Internal Diseases of the Perm Institute of Advanced Training of Healthcare Workers, Perm, Russia.
Dmitriy Yu. Sosnin – MD, PhD, DSc,Professor at the Department of Faculty Therapy No. 2, Occupational Pathology and Clinical Laboratory Diagnostics of the Wagner State Medical University, E. A. Vagner Perm State Medical University, Ministry of Health of Russian Federation, Perm, Russia.
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DOI: 10.14489/lcmp.2025.04.pp.026-032
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