title: The role of standards in the development and implementation of clinical laboratory tests: a domestic and global perspective.
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.
authors.affiliation: The US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850, USA. ginette.michaud@fda.hhs.gov
authors.forename: Ginette Y
authors.initials: GY
authors.lastname: Michaud
mesh_terms: D002624:Chemistry, Clinical / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D004470:Economics, Medical; D005060:Europe; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards; D012015:Reference Standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards