Association between SARS-CoV-2 Neutralizing Antibodies and Commercial Serological Assays
Association between SARS-CoV-2 Neutralizing Antibodies and Commercial Serological Assays
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DOI：
10.1093/clinchem/hvaa211
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发表时间：
2020-12-01
影响因子：
9.3
通讯作者：
Farnsworth, Christopher W.
中科院分区：
文献类型：
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作者：
Tang, Mei San;Case, James Brett;Farnsworth, Christopher W.
背景技术背景：基于不同病毒抗原的市售SARS-CoV-2血清学检测已被批准用于定性测定抗SARS-CoV-2抗体。然而，有有限的已发表的数据与中和antibody.METHODS的商业检测结果相关联：来自48例PCR证实的COVID-19患者的66份标本，以及Roche Elecsys Anti-SARS-CoV-2，Abbott SARS-CoV-2 IgG或EUROIMMUN SARS-CoV-2 IgG检测试剂盒的阳性结果和5份对照标本，分析了SARS-CoV-2中和抗体的存在。在几个临界点计算相关性、一致性、阳性一致率（PPA）和阴性一致率（NPA）。结果：SARS-CoV-2中和滴度（EC 50）与罗氏、雅培和EUROIMMUN检测的相关性分别为0.29、0.47和0.46。在EC 50为1：32时，与罗氏的一致性kappa为0.49（95% CI; 0.23-0.75），与雅培的一致性kappa为0.52（0.28-0.77），与欧复的一致性kappa为0.61（0.4-0.82）。在相同中和滴度下，罗氏的PPA和NPA分别为100%（94-100）和56%（30-80）;雅培为96%（88-99）和69%（44-86）; EUROIMMUN为91%（80-96）和81%（57-93），用于区分中和抗体。COVID-19感染导致的插管、心脏损伤或急性肾损伤患者的中和滴度高于症状轻微者。结论：COVID-19患者对多种病毒蛋白产生抗体应答，因此罗氏、雅培和EUROIMMUN检测试剂盒上的校准品比率均与SARS-CoV-2中和相关。然而，商业血清学检测对SARS-CoV-2中和的NPA很差，使得它们不能完美地替代中和。
BACKGROUND: Commercially available SARS-CoV-2 serological assays based on different viral antigens have been approved for the qualitative determination of antiSARS-CoV-2 antibodies. However, there are limited published data associating the results from commercial assays with neutralizing antibodies.METHODS: Sixty-six specimens from 48 patients with PCR-confirmed COVID-19 and a positive result by the Roche Elecsys Anti-SARS-CoV-2, Abbott SARS-CoV-2 IgG, or EUROIMMUN SARS-CoV-2 IgG assays and 5 control specimens were analyzed for the presence of neutralizing antibodies to SARS-CoV-2. Correlation, concordance, positive percent agreement (PPA), and negative percent agreement (NPA) were calculated at several cutoffs. Results were compared in patients categorized by clinical outcomes.RESULTS: The correlation between SARS-CoV-2 neutralizing titer (EC50) and the Roche, Abbott, and EUROIMMUN assays was 0.29, 0.47, and 0.46, respectively. At an EC50 of 1:32, the concordance kappa with Roche was 0.49 (95% CI; 0.23-0.75), with Abbott was 0.52 (0.28-0.77), and with EUROIMMUN was 0.61 (0.4-0.82). At the same neutralizing titer, the PPA and NPA for the Roche was 100% (94-100) and 56% (30-80); Abbott was 96% (88-99) and 69% (44-86); and EUROIMMUN was 91% (80-96) and 81% (57-93) for distinguishing neutralizing antibodies. Patients who were intubated, had cardiac injury, or acute kidney injury from COVID-19 infection had higher neutralizing titers relative to those with mild symptoms.CONCLUSIONS: COVID-19 patients generate an antibody response to multiple viral proteins such that the calibrator ratios on the Roche, Abbott, and EUROIMMUN assays are all associated with SARS-CoV-2 neutralization. Nevertheless, commercial serological assays have poor NPA for SARS-CoV-2 neutralization, making them imperfect proxies for neutralization.