Standards and Standardization of Molecular Diagnostics
J P. Jakupciak, C D. O'Connell
DNA has become a major target for clinical laboratory testing over the past 5 years, 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. Standrdized control reagents ensure the ability of diagnostic laboratories to pass proficiency testing and quality asurance, quality control (QA/QZ) (2). Consensus guidelines endorsed by professional societies and governmental agencies provide a framework for determining.
Molecular Diagnostics: For the Clinical Laboratorian