美国应对新冠疫情下一阶段对严重急性呼吸综合征冠状病毒2血清学检测的需求
SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.
作者信息
Gundlapalli Adi V, Salerno Reynolds M, Brooks John T, Averhoff Francisco, Petersen Lyle R, McDonald L Clifford, Iademarco Michael F
机构信息
Centers for Disease Control and Prevention, Atlanta, GA, USA.
出版信息
Open Forum Infect Dis. 2020 Nov 17;8(1):ofaa555. doi: 10.1093/ofid/ofaa555. eCollection 2021 Jan.
BACKGROUND
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.
METHODS
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.
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.
CONCLUSIONS
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.
背景
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）和中和试验，以了解SARS-CoV-2感染的免疫学和发病机制，并支持应对2019冠状病毒病（COVID-19）大流行。
方法
进行文献检索，以识别2020年1月至2020年11月6日期间同行评审期刊上的英文出版物和预印本。对相关出版物进行审查，以了解是否提及SARS-CoV-2的IgG或中和试验，或两者皆有，以及报告试验结果的方法。
结果
仅有少数研究报告了SARS-CoV-2定量IgG结果；大多数研究在有限的环境中使用内部实验室开发的检测方法，只有两项半定量检测获得了美国食品药品监督管理局（FDA）的紧急使用授权（EUA）。截至2020年11月6日，只有一项SARS-CoV-2中和试验获得了FDA的EUA。相对较少的研究尝试将定量IgG滴度与中和结果进行关联，以估计保护替代指标。与大流行的规模相比，检测的个体数量较少，且检测的人员不能代表受影响 disproportionately 的人群。报告定量结果的方法未标准化，无法进行比较和荟萃分析。
结论
缺乏标准化的SARS-CoV-2定量IgG和中和试验妨碍了对已发表研究结果的比较。试验间和实验室间的验证以及试验的标准化将有助于更好地了解疾病后抗体动力学和体液免疫反应的持久性、免疫保护替代指标以及疫苗的免疫原性和效力。公私伙伴关系可以促进在美国和全球实现这些进展。
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