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Metrological support for the process of molecular genetic identification is provided. An establishment of a nucleotide sequence is the general aim in nucleic acids analysis. A nucleotide sequence of DNA/RNA is the key information which gives an idea of the role and functioning of nucleic acids in living systems, as well as it allows establishing the origin of biological objects during molecular genetic identification. The molecular genetic identification is based on modern methods of research in the sequencing of DNA, which is inherited from generation to next generation of living organisms. DNA sequence comparison in some cases is mandatory to establish the authenticity of biological objects and to determine biological affiliation or kinship with other biological objects. The problems of metrological support of molecular genetic identification by Sanger DNA sequencing using fluorescently labeled reaction terminators and the use of capillary electrophoresis on the example of fish identification are considered. Metrological support of the process includes the use of such definitions as a nucleotide (the nucleic acid monomer), a sequence of nucleotides of nucleic acids. Also, it involves the procedures used in certified methods, a standard sample of a known DNA sequence of an approved type, and a genetic analyzer.Standard Reference Materials of a fragment of human mitochondrial DNA was developed, approved, entered into the Federal registry. The tests of the domestic genetic analyzer Nanophore 05 were carried out. Two measurement procedures “The measurement methodology the partial nucleotide sequence of the control region of mitochondrial DNA of fish (families Acipenseridae and Polyodontidae) by Sanger sequencing with fluorescently-labeled terminators and using capillary electrophoresis” and “The measurement methodology the nucleotide sequence of the 5’ region of the mitochondrial COI gene of water biological resources by Sanger sequencing with fluorescently-labeled terminators and using capillary electrophoresis” were tested and certified. The results are relevant to research in biological sciences, the food industry, biotechnology, and DNA forensics.

The most challenging problems in the field of chemico- and bioanalytical measurements are described. These problems are being solved, in particular, by participating in new international comparisons organized by the Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology of the International Committee of Weights and Measures (CCQM CIPM). Solutions of these challenging problems are presented. The objectives and tasks of developing key comparisons in the following areas are described: isotopic measurements; determination of the purity of substances; organic analysis; bioanalytical measurements; measurements of aerosol particle parameters; measurements in the field of gas analysis and electrochemistry. It is shown that participation in international key comparisons allows obtaining valid and reliable results of measurements of the composition and properties of gas and liquid media, as well as solid substances and materials.

Metrological support for DNA sequencing has been developed. Sequencing of a standard sample of a human mitochondrial DNA sequence was performed by the Sanger method on domestic capillary electrophoresis genetic analyzers Nanofor 05. The results of the work performed were used to approve the type of standard sample of human mitochondrial DNA sequence and the DNA sequence measuring instrument.

The article considers problems associated with the metrological support of catalytic activity measurement. The paper presents the characteristics of the State Primary Special Measurement Standard for the unit of catalytic activity—KATAL—and examines the role of reference materials (RMs) in ensuring the metrological traceability of measurement results. A method for measuring the concentration of the recombinant protective antigen of Bacillus anthracis and the recombinant GP-protein of the Ebola virus, involving the use of a “sandwich”-type enzyme-linked immunosorbent assay, was certified by VNIIMS as a measurement procedure. The following RMs tested by VNIIMS can be used for the development and production of appropriate control samples when performing measurements for comparisons: the RM for the mass concentration of the recombinant protective antigen of Bacillus anthracis in phosphate-saline solution, the RM for the mass concentration of the recombinant GP-protein of the Ebola virus and the RM for the mass concentration of recombinant Clostridium Difficile toxin. The paper presents the main reactions of the method for measuring the catalytic activity of catalysts for heterogeneous processes, which are also used to carry out reaction gas cleaning processes. Thus, conditions have been created for building hierarchies of calibrations of in-demand objects established on the basis of the List of Critical Technologies of the Russian Federation and state programs for the development of industrial sectors.

Methods and instrumentation for measuring catalytic activity that may be useful in the development of standards are analyzed. Analysis showed that, with all the variety of methods and instruments for measuring catalytic activity, during the development of the standard it is necessary to fulfill a set of mandatory requirements in the selection of objects for the study (catalysts), methods, and measuring instruments.

We analyze the normative and methodological support for measurements of catalytic activity for biological and chemical substances. We consider the results of work by experts at the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), who have studied optimized conditions for measuring catalytic activity concentration of individual enzymes in human blood serum. We have defined the problem of developing a reference standard for the unit of catalytic activity.

The relevance of metrological support of measurements carried out in laboratory medicine is examined to increase the accuracy of analyzes results, namely, measurements of the catalytic concentration of the human body enzymes. The development of reference materials with a long shelf life is discussed. The results of the development of Russian reference materials of the catalytic concentration of α-amylase and alkaline phosphatase are discussed. Based on the measuring model (Beer-Lambert-Bouguer law), sources of uncertainty are established. The developed reference materials make it possible to measure the catalytic concentration of enzymes with high reliability, make the correct diagnoses at the early stages of the disease, and make it possible to achieve the world level of metrological support of laboratory medicine in the field of measuring enzyme parameters.

We present a test procedure and test results for purposes of approval of type for real-time polymerase chain reaction (PCR) amplifiers.

Problems of verification and calibration of measurement provisions used in biological studies are considered. It is shown that comparison of results of calibration by standard specimens of composition and properties of substances in solution with those of measuring substances in a living biological matrix is incorrect. Creation of standard specimens based on a biological matrix is proposed for verification and calibration.