Kopel Jonathan, Goyal Hemant, Perisetti Abhilash
Texas Tech University Health Sciences Center, Lubbock, Texas.
The Wright Center for Graduate Medical Education, Scranton, Pennsylvania.
Proc (Bayl Univ Med Cent). 2020 Oct 13;34(1):63-72. doi: 10.1080/08998280.2020.1829261.
The SARS-CoV-2 virus caused a globally growing pandemic called coronavirus disease 2019 (COVID-19) that has disrupted social, political, and medical environments around the world. Nations are assessing ways to reopen businesses while trying to balance health care risks and economic fallouts. Strategies involving antibody testing have been proposed before phased reopening of the economy. Therefore, assessing the sensitivity and specificity of antibody tests for symptomatic and asymptomatic COVID-19 patients remains paramount to prevent COVID-19 outbreaks. The antibody tests for SARS-CoV-2 detect the presence of IgA, IgM, or IgG antibodies produced by B cells. There are four major types of antibody tests: rapid diagnostic tests, enzyme-linked immunosorbent assays, neutralization assays, and chemiluminescent immunoassays. Currently, there is no standard antibody test for detecting SARS-CoV-2 antibodies during or after exposure or infection. The antibody tests for SARS-CoV-2 have a low specificity within the first week of exposure and increase in the second and third weeks. The current data on antibody tests have several limitations in quality and the presence of bias. Specifically, many antibody tests have a high false-negative rate and a high risk of bias for participant selection, application of index tests, reference standard used, and flow and timing for antibody tests that may incorrectly report the accuracy of COVID-19 antibody tests. In this review, we summarize the current methods, sensitivity/specificity, and gaps in knowledge concerning COVID-19 antibody testing.
严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）引发了一场全球范围内不断蔓延的大流行，即2019冠状病毒病（COVID-19），它扰乱了世界各地的社会、政治和医疗环境。各国正在评估重新开放商业活动的方式，同时努力平衡医疗风险和经济影响。在分阶段重新开放经济之前，有人提出了涉及抗体检测的策略。因此，评估针对有症状和无症状COVID-19患者的抗体检测的敏感性和特异性对于预防COVID-19疫情仍然至关重要。SARS-CoV-2抗体检测用于检测B细胞产生的IgA、IgM或IgG抗体的存在。抗体检测主要有四种类型：快速诊断检测、酶联免疫吸附测定、中和测定和化学发光免疫测定。目前，在暴露或感染期间或之后，尚无用于检测SARS-CoV-2抗体的标准抗体检测方法。SARS-CoV-2抗体检测在暴露后的第一周特异性较低，在第二周和第三周有所提高。目前关于抗体检测的数据在质量和偏差方面存在若干局限性。具体而言，许多抗体检测的假阴性率很高，在参与者选择、指标检测应用、所用参考标准以及抗体检测的流程和时间安排方面存在很高的偏差风险，这可能会错误地报告COVID-19抗体检测的准确性。在本综述中，我们总结了当前关于COVID-19抗体检测的方法、敏感性/特异性以及知识空白。
