As DNA and RNA become major targets for clinical laboratory analysis, benchmark reagents will play an increasingly important role in standardization. Reliable national and international nucleic acid standards promote automation, third party reimbursement for clinical testing. Furthermore, nucleic acid standards provide materials for quality assurance and quality control (QA/QC), and proficiency testing. Standard methods and training initially evolved from consensus guidelines endorsed by professional societies and governmental agencies. The National Institute of Standards and Technology (NIST), a non-regulatory agency of the U. S. Department of Commerce, develops and certifies physical standards in support of national commerce, manufacturing and science. In its role supporting U. S. science and industry, NIST responds to specific standards needs, most recently for medically and biologically important analytes. Broad-based consensus developed through interdisciplinary NIST workshops initiated development of NIST-certified DNA-based standards. Such materials serve the diagnostic community and help manufacturers benchmark a variety of DNA diagnostic testing platforms. Here we summarize NIST experience and programs supporting national standards for DNA-based medical diagnostic testing.
Citation: Journal of Clinical Laboratory Analysis
Pub Type: Journals
diagnostics, DNA, genetics, NIST, SRM