Michaud Ginette Y
The US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850, USA.
Cancer Biomark. 2005;1(4-5):209-16. doi: 10.3233/cbm-2005-14-502.
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.
在临床检验医学领域，标准化旨在提高测量值的准确性和可靠性。标准化依赖于书面标准、参考测量程序和参考物质的使用。这些是设计和验证新检测方法以及建立诊断检测计量溯源性的重要工具。它们的使用有助于将研究技术转化为新的诊断检测方法，推动科学和医学更快发展，并提高患者护理质量。文中描述了各种标准化工具，以及制定书面标准、参考程序和参考物质的过程。还讨论了近期在分子诊断领域制定标准的努力。美国食品药品监督管理局（FDA）和其他监管机构对标准化工具的认可，证明了它们在确保体外诊断设备的安全性和性能方面的重要作用。
