Standardization of Nucleic Acid Tests: the Approach of the World Health Organization

The first World Health Organization (WHO) international standards (ISs) for nucleic acid amplification techniques were established two decades ago, with the initial focus on blood screening for three major viral targets, i.e., hepatitis C virus, hepatitis B virus, and human immunodeficiency virus 1....

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Bibliographic Details
Published in:Journal of clinical microbiology 2019-01, Vol.57 (1)
Main Authors: Baylis, S A, Wallace, P, McCulloch, E, Niesters, H G M, Nübling, C M
Format: Article
Language:English
Subjects:
Humans
International Cooperation
Laboratories - standards
Minireview
Nucleic Acid Amplification Techniques - standards
Nucleic Acids - chemistry
Nucleic Acids - genetics
Reference Standards
World Health Organization
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Summary:The first World Health Organization (WHO) international standards (ISs) for nucleic acid amplification techniques were established two decades ago, with the initial focus on blood screening for three major viral targets, i.e., hepatitis C virus, hepatitis B virus, and human immunodeficiency virus 1. These reference materials have subsequently found utility in the diagnosis and monitoring of a wide range of infectious diseases in clinical microbiology laboratories worldwide. WHO collaborating centers develop ISs and coordinate international studies for their evaluation. The WHO Expert Committee on Biological Standardization is responsible for the endorsement of new standardization projects and the establishment of new and replacement ISs. Potencies of ISs are defined in international units (IU); the reporting in IU for assays calibrated with an IS (or secondary standards traceable to the IS) facilitates comparability of results for different assays and determination of assay parameters such as analytical sensitivities.
ISSN:0095-1137
1098-660X
DOI:10.1128/JCM.01056-18