The Needs and Development of Physical Standards for Medical Diagnostics and Research


Barker, P.E.

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For clinical chemistry and biomedical applications, reference materials (RMs) or certified reference materials (CRMs) may take the form of neat materials of assessed purity, or solutions of analytes. A Standard Reference Material® (SRM) is a CRM issued by the United States National Institute of Standards and Technology (NIST). As SRMs are precious commodities, they typically are not intended for routine clinical or experimental applications as controls. Intended use descriptions often accompany supporting documentation of such standards. As part of continued NIST commitment to healthcare, recent NIST workshops have addressed standards and technology in areas such as nanotechnology and early cancer detection, HER2 testing of breast cancer, gene expression and serum proteomics for early cancer detection. Standards arise in response to clinical needs. Working in partnership with the standards user communities, NIST serves the national measurements community and has the specific federally mandated responsibility to meet high-priority reference material needs.