Reference Materials for Nominal Properties of Biological Substances

Metrological traceability of the research results of the nominal properties of biological substances is currently an unsolved problem. This is primarily due to the absence of CRMs for nominal properties, the lack of requirements and practices in the field of metrology for tools that ensure the traceability of the research results of nominal properties, such as the nucleotide sequence of nucleic acids, DNA, RNA, and the color of urine, and letter codes.

In the course of the research, the relevance of the development of the theory, requirements, and practice of using tools in Russian metrology to ensure the traceability of the research results of nominal properties is substantiated. Differences between the process of measurements and studies of nominal properties are given. A project of a metrological traceability chain of the research results of nominal properties to the international harmonization protocol is proposed, taking into account the fact that there are no primary standards of nominal properties, and there are no primary reference methods for measuring nominal properties. Methods for establishing the certified characteristics of reference materials of a fragment of human mitochondrial DNA and the inactivated strain «GK2020/1» of the coronavirus SARS-CoV-2, including additional characteristics of the nominal property «nucleotide sequence of nucleic acids», are presented. Thus, it has been established that the uncertainty of nominal properties can be expressed as a probability or level of confidence. In turn, reference materials of nominal properties are of high interest as a means of metrological assurance of the reliability of identification of the nominal properties of biological substances, which include the DNA nucleotide sequence (genes) of a human being. The main significance of the research is to create prerequisites for the application of the findings given in the work to create a new branch of metrology, which will be related to the creation of methods and means to ensure reliable results for determining the nominal properties of substances and materials.

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