WHO International Standards for Nucleic Acid Testing: Two Decades of Global Standardisation for Molecular Diagnostics
This review traces the development and impact of WHO international standards for nucleic acid amplification techniques, from initial standards for HCV, HBV, and HIV-1 blood screening to their broader adoption in clinical microbiology. Potencies defined in international units enable cross-assay comparability and accurate determination of analytical sensitivity. The WHO Expert Committee on Biological Standardization continues to establish new and replacement standards through international collaborative studies.
The original study
Standardization of Nucleic Acid Tests: the Approach of the World Health Organization.
- Authors
- Baylis SA, Wallace P, McCulloch E, Niesters HGM, Nübling CM
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Review
- PMID
- 30257900
Original abstract
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.