Open AccessNIST physical standards for DNA‐based medical testing
Author(s) -
Barker Peter E.,
Watson Michael S.,
Ticehurst John R.,
Colbert Jennifer C.,
O’Connell Catherine D.
Publication year - 2002
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.2062
Subject(s) - nist , standardization , quality assurance , reimbursement , certification , agency (philosophy) , engineering management , business , medical physics , computer science , engineering ethics , engineering , medicine , political science , health care , external quality assessment , operations management , philosophy , epistemology , natural language processing , law , operating system
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 and 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 nonregulatory agency of the U.S. Department of Commerce, develops and certifies physical and chemical standards in support of national commerce, manufacturing, and science. In its role supporting U.S. science and industry, the 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 standards. Such materials serve the diagnostic community and help manufacturers benchmark a variety of DNA diagnostic testing platforms. Here we summarize the NIST experience and programs for development of national standards for DNA‐based medical diagnostic testing. J. Clin. Lab. Anal. 16:5–10, 2002. © 2002 Wiley‐Liss, Inc.