On possibility of using routine biochemical techniques for research of alternative biological human liquids

Abstract

Biochemical studies of alternative human biological fluids are not common in laboratory practice due to the lack of validation methods. The aim of the study was to validatе on semen plasma routine biochemical research methods using an automatic biochemical analyzer. The studies were carried out on a Cobas Integra 400 plus automatic biochemical analyzer (Roche, Switzerland) using original Roche reagents (Switzerland). Materials for the study were 30 samples of semen plasma obtained from clinically healthy men of reproductive age. Planning and organization of validation activities were carried out in accordance with GOST ISO 15189–2015. The functional characteristics of the methods were determined in accordance with Order 45 of the Ministry of Health of the Russian Federation «On a system of measures to improve the quality of clinical laboratory research in healthcare facilities of the Russian Federation», and protocols of the CLSI Institute of Clinical Laboratory Standards (USA). It was possible to establish acceptable levels of linearity, precision and specificity for 31 of the 33 analytes studied. Also, the necessary dilution for 12 analytes was established empirically. Establishing the analytical reliability of biochemical methods for studying semen plasma opens up new possibilities for studying the metabolic characteristics of this biological fluid, and therefore expands the range of possibilities for its use as an object of laboratory research.