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Vol. 27, Art. 13 (pp. 311-330) | 2026
The significance of certified reference materials in the development and production of diagnostic test systems
Miteva O.A., Dal A.I., Kanevsky B.A., Myasnikov V.A.
State Scientific-research Test Institute of Military Medicine of Defense Ministry of the Russian Federation, St. Petersburg, Russia
Brief summary
Among modern rapid diagnostic methods, enzyme-linked immunosorbent assay (ELISA) and immunochromatographic analysis (ICA) occupy a particularly important position. However, it should be noted that the range of domestic diagnostic systems for pathogen and metabolite detection remains underdeveloped, creating a significant gap in the sanitary-epidemiological monitoring system. The primary limiting factor in this field's development is the lack of certified reference materials, which are critically important both for quality control of diagnostic preparations and for standardization of manufacturing processes. This review systematizes the key problems associated with the shortage of domestic reference standards, which pose potential threats to national biological security. Particular attention is given to methodological aspects of developing and validating new diagnostic platforms. Key words enzyme-linked immunosorbent assay, immunochemical analysis, monoclonal antibodies, polyclonal antibodies, certified reference material (The article in PDF format. For preview need Adobe Acrobat Reader)  Open article in new window
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