Molecular diagnostics: Harmonization through reference materials, documentary standards and proficiency testing

Published

September 1, 2011

Author(s)

Marcia J. Holden, 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

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Keywords

DNA, nucleic acid testing, NAT, documentary standards, molecular methods, genetic testing, proficiency testing, external quality assessment, infectious disease diagnostics, reference material

Citation

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 October 15, 2025)