Serology testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is increasingly being used during the current pandemic of Coronavirus Disease 2019 (COVID-19). The clinical and epidemiologic utilities of antibody-based SARS-CoV-2 testing are under debate. Characterizing these assays helps to understand the disease and provide scientific basis to decide how to best use these assays. The study assessed one chemiluminescent assay (Abbott COVID-2 IgG) and two lateral flow assays (STANDARD Q [SQ] IgM/IgG Duo and Wondfo Total Antibody Test). Validation included 113 blood samples from 71 PCR-confirmed COVID-19 patients and 1182 samples from negative controls and interferences/cross-reactions, including 1063 pre-pandemic samples. IgM antibodies against SARS-CoV-2 were detected as early as post-symptom onset days 3-4. IgG antibodies were first detected post-onset days 5-6 by SQ assays. The detection rates increased gradually, and SQ IgG, Abbott IgG and Wondfo Total detected antibodies from all the PCR-confirmed patients 14 days after symptom onset. Overall agreements between SQ IgM/IgG and Wondfo Total reached 88.5% and 94.6% between SQ IgG and Abbott IgG (Kappa = 0.75, 0.89). No cross-reaction with other endemic coronavirus infections were identified. Viral hepatitis and autoimmune samples were the main cross-reactions observed. However, the interferences/cross-reactions were low. The specificities were 100% for SQ IgG and Wondfo Total and 99.62% for Abbott IgG and 98.87% for SQ IgM. These findings demonstrate high sensitivity and specificity of appropriately validated antibody-based SARS-CoV-2 assays with implications for clinical use and epidemiological seroprevalence studies.

中文翻译：

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三种SARS-CoV-2抗体检测方法的验证和性能比较

在当前的2019年冠状病毒病（COVID-19）大流行期间，严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的血清学检测越来越多。基于抗体的SARS-CoV-2检测的临床和流行病学效用仍在争论中。表征这些测定有助于了解疾病，并为确定如何最佳使用这些测定提供科学依据。该研究评估了一种化学发光测定法（Abbott COVID-2 IgG）和两种侧向流动测定法（STANDARD Q [SQ] IgM / IgG Duo和Wondfo Total Antibody Test）。验证包括来自71位经PCR确认的COVID-19患者的113份血液样本，以及来自阴性对照和干扰/交叉反应的1182份样本，包括1063例大流行前样本。早在症状发作后第3-4天就检测到针对SARS-CoV-2的IgM抗体。IgG抗体是在发病后第5-6天通过SQ分析首先检测到的。检出率逐渐增加，症状发作后14天，SQ IgG，Abbott IgG和Wondfo Total检出了所有经PCR确诊的患者的抗体。SQ IgM / IgG与Wondfo Total的总体协议在SQ IgG和Abbott IgG之间分别达到88.5％和94.6％（Kappa = 0.75，0.89）。未发现与其他地方性冠状病毒感染有交叉反应。病毒性肝炎和自身免疫样本是观察到的主要交叉反应。但是，干扰/交叉反应很低。SQ IgG和Wondfo Total的特异性为100％，Abbott IgG的特异性为99.62％，SQ IgM的特异性为98.87％。