WHO Collaborating Centre for Quality Assurance of Blood Products and In Vitro Diagnostic Devices, Paul Ehrlich Institute, Langen, Germany
Quality Control for Molecular Diagnostics, Glasgow, United Kingdom.
J Clin Microbiol. 2019 Jan 2;57(1). doi: 10.1128/JCM.01056-18. Print 2019 Jan.
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.
二十年前，世界卫生组织（世卫组织）首次制定了核酸扩增技术国际标准（ISs），最初的重点是对三种主要病毒靶标（丙型肝炎病毒、乙型肝炎病毒和人类免疫缺陷病毒 1）进行血液筛查。此后，这些参考物质在全球临床微生物学实验室用于诊断和监测各种传染病方面得到了应用。世卫组织合作中心制定 ISs 并协调其评估的国际研究。世卫组织生物标准化专家委员会负责批准新项目和建立新的和替代的 ISs。ISs 的效价以国际单位（IU）定义；用 IS（或可追溯至 IS 的二级标准）校准的检测方法报告 IU，有助于不同检测方法结果的可比性，并确定检测参数，如分析灵敏度。
