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

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

SUBMITTER: Baylis SA 

PROVIDER: S-EPMC6322456 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature