Department of Laboratory Medicine and Pathology, University of Minnesotagrid.17635.36, Minneapolis, Minnesota, USA.
Department of Molecular Microbiology & Immunology, Saint Louis Universitygrid.262962.b, St. Louis, Missouri, USA.
mSphere. 2022 Aug 31;7(4):e0019322. doi: 10.1128/msphere.00193-22. Epub 2022 Jun 15.
In October 2020, the National Cancer Institute (NCI) Serological Sciences Network (SeroNet) was established to study the immune response to COVID-19, and "to develop, validate, improve, and implement serological testing and associated technologies" (https://www.cancer.gov/research/key-initiatives/covid-19/coronavirus-research-initiatives/serological-sciences-network). SeroNet is comprised of 25 participating research institutions partnering with the Frederick National Laboratory for Cancer Research (FNLCR) and the SeroNet Coordinating Center. Since its inception, SeroNet has supported collaborative development and sharing of COVID-19 serological assay procedures and has set forth plans for assay harmonization. To facilitate collaboration and procedure sharing, a detailed survey was sent to collate comprehensive assay details and performance metrics on COVID-19 serological assays within SeroNet. In addition, FNLCR established a protocol to calibrate SeroNet serological assays to reference standards, such as the U.S. severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology standard reference material and first WHO international standard (IS) for anti-SARS-CoV-2 immunoglobulin (20/136), to facilitate harmonization of assay reporting units and cross-comparison of study data. SeroNet institutions reported development of a total of 27 enzyme-linked immunosorbent assay (ELISA) methods, 13 multiplex assays, and 9 neutralization assays and use of 12 different commercial serological methods. FNLCR developed a standardized protocol for SeroNet institutions to calibrate these diverse serological assays to reference standards. In conclusion, SeroNet institutions have established a diverse array of COVID-19 serological assays to study the immune response to SARS-CoV-2 and vaccines. Calibration of SeroNet serological assays to harmonize results reporting will facilitate future pooled data analyses and study cross-comparisons. SeroNet institutions have developed or implemented 61 diverse COVID-19 serological assays and are collaboratively working to harmonize these assays using reference materials to establish standardized reporting units. This will facilitate clinical interpretation of serology results and cross-comparison of research data.
2020 年 10 月，美国国家癌症研究所（NCI）血清科学网络（SeroNet）成立，旨在研究 COVID-19 的免疫反应，并“开发、验证、改进和实施血清学检测及相关技术”（https://www.cancer.gov/research/key-initiatives/covid-19/coronavirus-research-initiatives/serological-sciences-network）。SeroNet 由 25 个参与研究机构组成，与弗雷德里克国家癌症研究实验室（FNLCR）和 SeroNet 协调中心合作。自成立以来，SeroNet 一直支持 COVID-19 血清学检测方法的合作开发和共享，并制定了检测方法协调计划。为了促进合作和程序共享，向 SeroNet 内的各机构发送了一份详细的调查，以整理 COVID-19 血清学检测方法的综合检测细节和性能指标。此外，FNLCR 建立了一个方案，用美国严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）血清学标准参考物质和世界卫生组织（WHO）首次 SARS-CoV-2 免疫球蛋白国际标准（IS）20/136 等参考标准校准 SeroNet 血清学检测，以促进检测报告单位的协调和研究数据的交叉比较。SeroNet 各机构报告共开发了 27 种酶联免疫吸附测定（ELISA）方法、13 种多重检测方法和 9 种中和检测方法，使用了 12 种不同的商业血清学方法。FNLCR 为 SeroNet 各机构制定了一个标准化方案，用这些参考标准校准这些多样化的血清学检测。总之，SeroNet 各机构建立了多种 COVID-19 血清学检测方法来研究对 SARS-CoV-2 和疫苗的免疫反应。用参考标准校准 SeroNet 血清学检测以协调结果报告将有助于未来进行汇总数据分析和研究数据的交叉比较。SeroNet 各机构已经开发或实施了 61 种不同的 COVID-19 血清学检测方法，并正在合作使用参考材料来协调这些检测方法，以建立标准化的报告单位。这将有助于临床解释血清学结果和比较研究数据。
