Department of Clinical Biochemistry, East Lancashire Hospitals NHS Trust, Blackburn, UK.
Department of Clinical Biochemistry, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.
Ann Clin Biochem. 2021 Sep;58(5):487-495. doi: 10.1177/00045632211015711. Epub 2021 Jun 2.
A number of immunoassays have been developed to measure antibodies specific to SARS-CoV-2. More data is required on their comparability, particularly among those with milder infections and in the general practice population. The aim of this study was to compare four high-throughput automated anti-SARS-CoV-2 assays using samples collected from hospitalized patients and healthcare workers with confirmed SARS-CoV-2 infection. In addition, we collected general practice samples to compare antibody results and determine seroprevalence.
Samples were collected from 57 hospitalized patients and nine healthcare workers at 14 days and at 28 days following confirmed SARS-CoV-2 infection. Samples were also collected from 225 patients presenting to general practice. Four assays were used: Abbott Architect IgG, Beckman Coulter DxI 800 IgG, Roche Cobas e801 total antibody and Siemens Advia Centaur XPT total antibody.
All four assays showed concordance at 14 days in 83.9% of hospitalized patients and in 66.7% of healthcare workers. All four assays showed concordance at 28 days in 88.4% of hospitalized patients and 77.8% of healthcare workers. The sensitivity to detect recent infection was higher for the IgG assays than the total assays. All four assays showed concordance of 95.1% in the general practice population. Seroprevalence ranged from 4.9 to 5.8% depending on the assay used.
All four assays showed excellent comparability, but it may be possible to obtain a negative result for any of the anti-SARS-CoV-2 assays in patients with confirmed previous SARS-CoV-2 infection. An equivocal range would be useful for all anti-SARS-CoV-2 assays.
已经开发出许多免疫测定法来测量针对 SARS-CoV-2 的特异性抗体。需要更多关于它们可比性的数据，尤其是在感染较轻的患者和普通科医生群体中。本研究的目的是比较使用从住院患者和确诊 SARS-CoV-2 感染的医护人员中收集的样本的四种高通量自动化抗 SARS-CoV-2 测定法。此外，我们还收集了普通科医生的样本，以比较抗体结果并确定血清流行率。
从 57 名住院患者和 9 名医护人员中采集样本，分别在确诊 SARS-CoV-2 感染后的 14 天和 28 天采集。还从 225 名就诊于普通科医生的患者中采集样本。使用了四种测定法：雅培 Architect IgG、贝克曼库尔特 DxI 800 IgG、罗氏 Cobas e801 总抗体和西门子 Advia Centaur XPT 总抗体。
在 83.9%的住院患者和 66.7%的医护人员中，所有四种测定法在 14 天时均具有一致性。在 88.4%的住院患者和 77.8%的医护人员中，所有四种测定法在 28 天时均具有一致性。检测近期感染的 IgG 测定法的敏感性高于总抗体测定法。在普通科医生群体中，所有四种测定法的一致性为 95.1%。根据使用的测定法，血清流行率范围为 4.9%至 5.8%。
所有四种测定法均具有出色的可比性，但在确诊之前有 SARS-CoV-2 感染的患者中，任何一种抗 SARS-CoV-2 测定法都可能获得阴性结果。对于所有抗 SARS-CoV-2 测定法，出现不确定范围可能会很有用。
