SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.
SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.
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DOI：
10.1093/ofid/ofaa555
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发表时间：
2021-01
影响因子：
4.2
通讯作者：
CDC COVID-19 Response
中科院分区：
文献类型：
--
作者：
Gundlapalli AV;Salerno RM;Brooks JT;Averhoff F;Petersen LR;McDonald LC;Iademarco MF;CDC COVID-19 Response
需要经过验证和标准化的严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 定量免疫球蛋白 G (IgG) 和中和测定，可用于了解 SARS-CoV-2 感染的免疫学和发病机制，并支持应对 2019 年冠状病毒病 (COVID-19) 大流行应对措施。我们进行了文献检索，以识别 2020 年 1 月至 2020 年 11 月 6 日期间同行评审期刊和预印本中的英文出版物。审查了相关出版物中是否提及 SARS-CoV-2 的 IgG 或中和测定，或两者，以及报告测定结果的方法。数量有限的研究报告了 SARS-CoV-2 IgG 定量结果；大多数研究在有限的环境下使用内部实验室开发的测试，并且只有两项半定量测试获得了美国食品和药物管理局 (FDA) 紧急使用授权 (EUA)。截至 2020 年 11 月 6 日，只有一项获得 FDA EUA 的 SARS-CoV-2 中和检测。相对较少的研究尝试将定量 IgG 滴度与中和结果相关联来估计保护的替代值。与大流行的严重程度相比，接受检测的人数很少，而且接受检测的人并不代表受影响较大的人群。报告定量结果的方法尚未标准化，无法进行比较和荟萃分析。由于缺乏标准化的 SARS-CoV-2 定量 IgG 和中和测定，无法对已发表的研究结果进行比较。测定间和实验室间验证以及测定标准化将支持更好地了解抗体动力学和病后体液免疫反应的寿命、免疫保护的替代物以及疫苗免疫原性和功效的努力。公私伙伴关系可以促进在美国和全世界实现这些进步。
There is a need for validated and standardized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative immunoglobulin G (IgG) and neutralization assays that can be used to understand the immunology and pathogenesis of SARS-CoV-2 infection and support the coronavirus disease 2019 (COVID-19) pandemic response. Literature searches were conducted to identify English language publications from peer-reviewed journals and preprints from January 2020 through November 6, 2020. Relevant publications were reviewed for mention of IgG or neutralization assays for SARS-CoV-2, or both, and the methods of reporting assay results. Quantitative SARS-CoV-2 IgG results have been reported from a limited number of studies; most studies used in-house laboratory-developed tests in limited settings, and only two semiquantitative tests have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of November 6, 2020, there is only one SARS-CoV-2 neutralization assay with FDA EUA. Relatively few studies have attempted correlation of quantitative IgG titers with neutralization results to estimate surrogates of protection. The number of individuals tested is small compared with the magnitude of the pandemic, and persons tested are not representative of disproportionately affected populations. Methods of reporting quantitative results are not standardized to enable comparisons and meta-analyses. Lack of standardized SARS-CoV-2 quantitative IgG and neutralization assays precludes comparison of results from published studies. Interassay and interlaboratory validation and standardization of assays will support efforts to better understand antibody kinetics and longevity of humoral immune responses postillness, surrogates of immune protection, and vaccine immunogenicity and efficacy. Public–private partnerships could facilitate realization of these advances in the United States and worldwide.
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