Nominal Reference Materials of Biological Substances

For biological substances, nominal examination traceability currently remains an unresolved issue. This is primarily associated with the lack of certified nominal reference materials (RMs), as well as requirements and practices for using tools in the field of metrology that could ensure nominal examination traceability for such properties as “nucleic acid sequence (RNA and DNA),” urine color; and letter codes. The study justifies the relevance of developing an application theory for such tools in Russian metrology, as well as the specified aspects. The differences between measurement and nominal examination are outlined. Also, a draft chain of nominal examination traceability to an international harmonization protocol is proposed. Methods for ascertaining certified RM characteristics of human mitochondrial DNA fragment and inactivated SARS-CoV-2 “GC2020/1” strain are presented, including additional characteristics attributed to the “nucleic acid sequence” property. It is established that the uncertainty of nominal properties can be expressed as probability or confidence level. The authors note the role of nominal RMs in the reliable identification of nominal properties in biological substances. This study provides the foundation for implementing the presented conclusions in a new branch of metrology concerned with developing methods and means for ensuring reliable nominal examination of substances and materials.