Holden, M.
, Madej, R.
, Minor, P.
and Kalman, L.
(2011),
Molecular diagnostics: Harmonization through reference materials, documentary standards and proficiency testing, Expert Review of Molecular Diagnostics, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=908173
(Accessed April 24, 2024)
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Molecular diagnostics: Harmonization through reference materials, documentary standards and proficiency testing
Published
Author(s)
, Roberta M. Madej, Philip Minor, Lisa V. Kalman
Abstract
There is a great need for harmonization in nucleic acid testing for infectious disease and clinical genetics. The proliferation of assay methods, the number of targets for molecular diagnostics and the dearth of reference materials contribute to variability in test results from one laboratory to another. This article provides a comprehensive overview of reference materials, related documentary standards, and proficiency testing programs. The review explores the relationship between these resources and provides necessary information for people practicing in this area that is not taught in formal courses and frequently has to be picked up ad hoc. It is hoped that this review will provide helpful tools for molecular diagnostic laboratories.Citation
Expert Review of Molecular Diagnostics
Pub Type
Journals
Download Paper
Keywords
DNA, nucleic acid testing, NAT, documentary standards, molecular methods, genetic testing, proficiency testing, external quality assessment, infectious disease diagnostics, reference material
Citation
Created September 1, 2011, Updated February 19, 2017