在 2019 年冠状病毒病疫情后，对一个经过全面 PCR 检测的社区使用六种不同血清学检测方法进行抗体反应的研究——CoNAN 研究。
Antibody response using six different serological assays in a completely PCR-tested community after a coronavirus disease 2019 outbreak-the CoNAN study.
机构信息
Institute for Infectious Diseases and Infection Control, Jena University Hospital - Friedrich Schiller University, Jena, Germany; Centre for Sepsis Control and Care (CSCC), Jena University Hospital - Friedrich Schiller University, Jena, Germany; Department of Anaesthesiology and Intensive Care, Jena University Hospital - Friedrich Schiller University, Jena, Germany.
Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital - Friedrich Schiller University, Jena, Germany.
出版信息
Clin Microbiol Infect. 2021 Mar;27(3):470.e1-470.e9. doi: 10.1016/j.cmi.2020.11.009. Epub 2020 Nov 20.
OBJECTIVES
Due to a substantial proportion of asymptomatic and mild courses, many severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections remain unreported. Therefore, assessment of seroprevalence may detect the real burden of disease. We aimed to determine and characterize the rate of SARS-CoV-2 infections and the resulting seroprevalence in a defined population. The primary objective of the study was to assess SARS-CoV-2 antibody seroprevalence using six different IgG-detecting immunoassays. Secondary objectives of the study were: (a) to determine potential risk factors for symptomatic versus asymptomatic coronavirus disease 2019 courses, and (b) to investigate the rate of virus RNA-persistence.
METHODS
CoNAN is a population-based cohort study performed in the community Neustadt am Rennsteig, Germany, which was quarantined from 22 March to 5 April after six SARS-CoV-2 cases were detected in the village's population. The SARS-CoV-2 outbreak comprised 51 cases and 3 deaths. The CoNAN study was performed from 13 May to 22 May 2020, 6 weeks after a SARS-CoV-2 outbreak.
RESULTS
We enrolled a total of 626 participants (71% of the community population) for PCR and antibody testing in the study. All actual SARS-CoV-2 PCR tests were negative. Fifty-two out of 620 (8.4%) participants had antibodies against SARS-CoV-2 in at least two different assays. There were 38 participants with previously PCR-confirmed SARS-CoV-2 infection. Of those, only 19 (50%) displayed anti-SARS-CoV-2 antibodies. We also show that antibody-positive participants with symptoms compatible with a respiratory tract infection had significantly higher antibody levels then asymptomatic participants (EU-assay: median 2.9 versus 7.2 IgG-index, p 0.002; DS-assay: median 45.2 versus 143 AU/mL, p 0.002). Persisting viral replication was not detected.
CONCLUSIONS
Our data question the relevance and reliability of IgG antibody testing to detect past SARS-CoV-2 infections 6 weeks after an outbreak. We conclude that assessing immunity for SARS-CoV-2 infection should not rely on antibody tests alone.
目的
由于相当一部分严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染患者无症状或症状较轻，因此许多感染病例并未报告。因此，血清流行率评估可能会发现实际的疾病负担。本研究旨在确定并描述特定人群中 SARS-CoV-2 感染的发生率和由此产生的血清流行率。本研究的主要目的是使用六种不同的 IgG 检测免疫分析法评估 SARS-CoV-2 抗体血清阳性率。本研究的次要目的是：（a）确定有症状与无症状 2019 年冠状病毒病（COVID-19）患者之间的潜在危险因素，以及（b）调查病毒 RNA 持续存在的发生率。
方法
CoNAN 是一项在德国 Neustadt am Rennsteig 社区进行的基于人群的队列研究，在该村居民中发现 6 例 SARS-CoV-2 病例后，该社区于 2020 年 3 月 22 日至 4 月 5 日被隔离。此次 SARS-CoV-2 暴发共涉及 51 例病例和 3 例死亡。CoNAN 研究于 2020 年 5 月 13 日至 22 日进行，这是在 SARS-CoV-2 暴发后 6 周进行的。
结果
我们总共招募了 626 名参与者（社区人口的 71%）进行 PCR 和抗体检测。所有实际的 SARS-CoV-2 PCR 检测均为阴性。在 620 名参与者中，有 52 名（8.4%）至少在两种不同的检测中具有针对 SARS-CoV-2 的抗体。有 38 名参与者之前通过 PCR 确诊患有 SARS-CoV-2 感染。其中，只有 19 名（50%）显示出抗 SARS-CoV-2 抗体。我们还表明，症状与呼吸道感染相符的抗体阳性参与者的抗体水平明显高于无症状参与者（EU 检测：中位数 2.9 与 7.2 IgG 指数，p<0.002；DS 检测：中位数 45.2 与 143 AU/mL，p<0.002）。未检测到持续的病毒复制。
结论
我们的数据对 IgG 抗体检测在暴发后 6 周检测过去 SARS-CoV-2 感染的相关性和可靠性提出了质疑。我们得出的结论是，评估 SARS-CoV-2 感染的免疫能力不应仅依赖于抗体检测。
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