Standards and Standardization of Molecular Diagnostics

Abstract

DNA has become a major target for clinical laboratory testing over the past 5 yr, and RNA testing is emerging for infectious disease and gene expression (1). To normalize laboratory results across different technology platforms as well as between laboratories, standardized reagents will become increasingly important. Reliable standards promote the speed at which a diagnostic test can be offered, as well as third-party reimbursement. Standardized control reagents ensure the ability of diagnostic laboratories to pass proficiency testing and quality assurance/quality control (QA/QC) measurements (2). Consensus guidelines endorsed by professional societies and governmental agencies provide a framework for determining standardization needs. In its role supporting US science and industry, the National Institute of Standards and Te c hnology (NIST), a nonregulatory agency of the US Department of Commerce, provides physical and chemical standards in support of national commerce, manufacturing, and science (3). These materials are available internationally as Standard Reference Materials (SRMs) for use by industry developing assays and/or technology platforms for diagnostic use, by regulatory agencies ensuring the quality and efficacy of these assays, and by clinical laboratories providing diagnostic tests for patients. Traditionally, NIST responds to standard needs as defined by these communities. Consensus is developed through NIST workshops attended by representatives of these communities as well as direct request by other governmental agencies. Specific examples of ongoing programs within the Biotechnology Division at NIST are described in this chapter.KeywordsFull Mutation AlleleNational CommerceSequence Context EffectThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.