Department of Health Products Policy and Standards, Access to Medicines and Health Products, World Health Organization, Geneva, Switzerland.
National Institute for Biological Standards and Control, Potters Bar, UK.
Lancet Microbe. 2022 Mar;3(3):e235-e240. doi: 10.1016/S2666-5247(21)00266-4. Epub 2021 Oct 26.
The first WHO International Standard and International Reference Panel for anti-SARS-CoV-2 immunoglobulin were established by the WHO Expert Committee on Biological Standardization in December, 2020. The WHO International Antibody Standards are intended to serve as global reference reagents, against which national reference preparations or secondary standards can be calibrated. Calibration will facilitate comparison of results of assays (eg, of the neutralising antibody response to candidate COVID-19 vaccines) conducted in different countries. Use of these standards is expected to contribute to better understanding of the immune response, and particularly of the correlates of protection. This Personal View provides some technical details of the WHO Antibody Standards for SARS-CoV-2, focusing specifically on the use of these standards for the evaluation of the immune response to COVID-19 vaccines, rather than other applications (eg, diagnostic or therapeutic). The explanation with regard to why rapid adoption of the standards is crucial is also included, as well as how funders, journals, regulators, and ethics committees could drive adoption in the interest of public health.
世界卫生组织于 2020 年 12 月成立了首个针对 SARS-CoV-2 免疫球蛋白的世卫组织国际标准和国际参考品专家委员会。世卫组织国际抗体标准旨在作为全球参考试剂，各国的参考制剂或二级标准可据此进行校准。校准将有助于比较不同国家进行的检测（例如，对候选 COVID-19 疫苗的中和抗体反应）结果。这些标准的使用有望促进对免疫反应的更好理解，特别是对保护相关因素的理解。本个人观点提供了世卫组织针对 SARS-CoV-2 的抗体标准的一些技术细节，特别侧重于使用这些标准评估 COVID-19 疫苗的免疫反应，而不是其他应用（例如诊断或治疗）。还包括解释为什么迅速采用这些标准至关重要，以及供资者、期刊、监管机构和伦理委员会如何为了公共卫生利益推动采用这些标准。
