Department of Immunology, Mater Private Hospital, Dublin, Ireland.
Department of Clinical Biochemistry, Mater Private Hospital, Dublin, Ireland.
Ann Clin Biochem. 2021 Sep;58(5):496-504. doi: 10.1177/00045632211012728. Epub 2021 Jun 2.
SARS-CoV-2, which causes coronavirus disease (COVID-19), continues to cause significant morbidity and mortality. The diagnosis of acute infection relies on reverse transcription-polymerase chain reaction (RT-PCR)-based viral detection. The objective of this study was to evaluate the optimal serological testing strategy for anti-SARS-CoV-2 antibodies which provides an important indicator of prior infection and potential short-term immunity.
The sensitivity and specificity of four different ELISA assays (Euroimmun IgG, Euroimmun NCP-IgG, Fortress and DIAsource) and one CLIA assay (Roche ELECSYS) were evaluated in 423 samples; 137 patients with confirmed RT-PCR COVID-19 infection (true positives), and 100 pre-pandemic samples collected prior to October 2019 (true negatives). A further 186 samples were collected from health-care staff and analysed by all five assays.
The Fortress ELISA assay demonstrated the highest sensitivity and specificity followed by the Roche ECLIA assay. The highest overall sensitivity came from the assays that measured total antibody (IgM-IgG combined) and the three assays that performed the best (Fortress, Roche, Euroimmun IgG) all have different antigens as their target proteins which suggests that antigen target does not affect assay performance. In mildly symptomatic participants with either a negative RT-PCR or no RT-PCR performed, 16.76% had detectable antibodies suggesting previous infection.
We recommend a combined testing strategy utilizing assays with different antigenic targets using the fully automated Roche ECLIA assay and confirming discordant samples with the Fortress Total Antibody ELISA assay. This study provides an important indicator of prior infection in symptomatic and asymptomatic individuals.
导致冠状病毒病（COVID-19）的 SARS-CoV-2 继续导致严重的发病率和死亡率。急性感染的诊断依赖于基于逆转录-聚合酶链反应（RT-PCR）的病毒检测。本研究的目的是评估抗 SARS-CoV-2 抗体的最佳血清学检测策略，该策略提供了先前感染和潜在短期免疫的重要指标。
在 423 份样本中评估了四种不同 ELISA 检测（Euroimmun IgG、Euroimmun NCP-IgG、Fortress 和 DIAsource）和一种 CLIA 检测（罗氏 ELECSYS）的敏感性和特异性；137 例经证实的 RT-PCR COVID-19 感染患者（真阳性）和 100 例 2019 年 10 月前采集的大流行前样本（真阴性）。另外 186 份样本来自医护人员，并用所有五种检测方法进行分析。
Fortress ELISA 检测显示出最高的敏感性和特异性，其次是罗氏 ECLIA 检测。总抗体（IgM-IgG 联合）检测的三个检测（Fortress、罗氏、Euroimmun IgG）的总体敏感性最高，表现最好的三个检测（Fortress、罗氏、Euroimmun IgG）都有不同的抗原作为其靶蛋白，这表明抗原靶标不会影响检测性能。在有阴性 RT-PCR 或未进行 RT-PCR 的轻度症状参与者中，有 16.76%的人检测到抗体，提示先前感染。
我们建议采用不同抗原靶标的联合检测策略，使用全自动罗氏 ECLIA 检测，并用 Fortress 总抗体 ELISA 检测确认不一致的样本。本研究为有症状和无症状个体的先前感染提供了重要指标。
