Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York, USA.
Department of Chemistry and Life Science, United States Military Academy at West Point, West Point, New York, USA.
mSphere. 2021 Apr 21;6(2):e00224-21. doi: 10.1128/mSphere.00224-21.
The coronavirus disease 2019 (COVID-19) global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to place an immense burden on societies and health care systems. A key component of COVID-19 control efforts is serological testing to determine the community prevalence of SARS-CoV-2 exposure and quantify individual immune responses to prior SARS-CoV-2 infection or vaccination. Here, we describe a laboratory-developed antibody test that uses readily available research-grade reagents to detect SARS-CoV-2 exposure in patient blood samples with high sensitivity and specificity. We further show that this sensitive test affords the estimation of viral spike-specific IgG titers from a single sample measurement, thereby providing a simple and scalable method to measure the strength of an individual's immune response. The accuracy, adaptability, and cost-effectiveness of this test make it an excellent option for clinical deployment in the ongoing COVID-19 pandemic. Serological surveillance has become an important public health tool during the COVID-19 pandemic. Detection of protective antibodies and seroconversion after SARS-CoV-2 infection or vaccination can help guide patient care plans and public health policies. Serology tests can detect antibodies against past infections; consequently, they can help overcome the shortcomings of molecular tests, which can detect only active infections. This is important, especially when considering that many COVID-19 patients are asymptomatic. In this study, we describe an enzyme-linked immunosorbent assay (ELISA)-based qualitative and quantitative serology test developed to measure IgG and IgA antibodies against the SARS-CoV-2 spike glycoprotein. The test can be deployed using commonly available laboratory reagents and equipment and displays high specificity and sensitivity. Furthermore, we demonstrate that IgG titers in patient samples can be estimated from a single measurement, enabling the assay's use in high-throughput clinical environments.
2019 年冠状病毒病（COVID-19）大流行是由严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）引起的，它继续给社会和医疗保健系统带来巨大负担。COVID-19 控制工作的一个关键组成部分是血清学检测，以确定 SARS-CoV-2 暴露的社区流行率，并量化个体对先前 SARS-CoV-2 感染或疫苗接种的免疫反应。在这里，我们描述了一种使用现成的研究级试剂的实验室开发的抗体检测方法，该方法具有高灵敏度和特异性，可以检测患者血液样本中的 SARS-CoV-2 暴露情况。我们进一步表明，这种灵敏的检测方法可以从单个样本测量中估计病毒刺突特异性 IgG 滴度，从而提供了一种简单且可扩展的方法来测量个体免疫反应的强度。该测试的准确性、适应性和成本效益使其成为当前 COVID-19 大流行中临床部署的绝佳选择。血清学监测已成为 COVID-19 大流行期间的重要公共卫生工具。检测 SARS-CoV-2 感染或接种疫苗后的保护性抗体和血清转化可以帮助指导患者护理计划和公共卫生政策。血清学检测可以检测针对过去感染的抗体；因此，它们可以克服分子检测的缺点，分子检测只能检测到活跃的感染。这一点很重要，尤其是考虑到许多 COVID-19 患者无症状。在这项研究中，我们描述了一种基于酶联免疫吸附试验（ELISA）的定性和定量血清学检测方法，用于测量针对 SARS-CoV-2 刺突糖蛋白的 IgG 和 IgA 抗体。该测试可以使用常用的实验室试剂和设备进行部署，具有很高的特异性和灵敏度。此外，我们证明可以从单个测量中估计患者样本中的 IgG 滴度，从而使该检测能够在高通量临床环境中使用。
