Affiliations: The US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850, USA | NIST Division of Biochemical Sciences, Chemical Sciences and Technology Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, USA
Correspondence:
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Address for correspondence: Ginette Y. Michaud, MD, US Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, HFZ-480, 9200 Corporate Blvd., Rockville, MD 20850, USA. Tel.: +1 301 443 8913; Fax: +1 301 480 3002; E-mail: ginette.michaud@fda.hhs.gov.
Abstract: In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.
Keywords: Written standards, reference measurement procedures, reference materials, metrological traceability, Food and Drug Administration
