NIST physical standards for DNA‐based medical testing

Abstract

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.

Real-time reverse transcription PCR and the detection of occult disease in colorectal cancer

“…If other detection technologies, such as expression profiling using microarrays, follow the same standardisation protocol, all the results might be comparable. The importance of this kind of standardisation is well recognised and standards for DNA-based medical diagnostic testing are being defined (Barker et al, 2002). RNA-based assays are still lagging behind, but as a first step consensus opinions have been gathered with the aim of generating reagents to help in the standardisation of gene-expression technologies (Cronin et al, 2004).…”

Cancer Biomarker Validation: Standards and Process

“…It has a long history of standards development under its former name, the U.S. Bureau of Standards 12. Only recently has NIST undertaken work related to cancer molecular genetics technology and standards,13,14 although NIST standards work in health care and clinical chemistry is well established 15. NIST programs in technology development and quality control and assurance (QA/QC) for genotyping, DNA sequencing, and DNA storage16 grew out of needs in the United States' forensics and military human identification communities.…”

“…There are conceptually several types of standards for laboratory assays. An ultimate gold standard analyte that is guaranteed to contain the specified number of analyte molecules per volume is represented by the NIST Standard Reference Material (SRM ™ ) designation 13–15,19. Primary standards like SRMs are produced at NIST as national standards and are available for sale to all interested parties.…”

“…The numerous DNA‐based SRMs offered or in the developmental or production pathway at NIST are relevant to human genetics, clinical pathology, and forensics. These molecular genetics health‐related SRMs and the developmental process of nucleic acid‐based SRMs have been described 13,14…”

Universal RNA Reference Materials for Gene Expression

“…NIST traditionally supports industry by developing the measurements, models, data, and standards needed to accelerate the commercialization of products and to ensure product quality and integrity (2 ). The primary goal of the workshop was to address the needs of the gene expression community for standardization in this developing field of investigation.…”