This study assessed the diagnostic performance of the new COVID19SEROSpeed IgM/IgG rapid test (BioSpeedia, a spinoff of the Pasteur Institute of Paris) for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in comparison to other commercial antibody assays through a large cross-European investigation. The clinical specificity was assessed on 215 prepandemic sera (including some from patients with viral infections or autoimmune disorders). The clinical sensitivity was evaluated on 710 sera from 564 patients whose SARS-CoV-2 infection was confirmed by quantitative reverse transcription-PCR (qRT-PCR) and whose antibody response was compared to that measured by five other commercial tests. The kinetics of the antibody response were also analyzed in seven symptomatic patients. The specificity of the test (BioS) on prepandemic specimens was 98.1% (95% confidence interval [CI], 96.2% to 99.4%). When tested on the 710 pandemic specimens, BioS showed an overall clinical sensitivity of 86.0% (95% CI, 0.83 to 0.89), with good concordance with the Euroimmun assay (overall concordance of 0.91; Cohen’s kappa coefficient of 0.62). Due in part to simultaneous detection of IgM and IgG for both S1 and N proteins, BioS exhibited the highest positive percent agreement at ≥11 days post-symptom onset (PSO). In conclusion, the BioS IgM/IgG rapid test was highly specific and demonstrated a higher positive percentage of agreement than all the enzyme-linked immunosorbent assay/chemiluminescence immunoassay (ELISA/CLIA) commercial tests considered in this study. Moreover, by detecting the presence of antibodies prior to 11 days PSO in 78.2% of the patients, the BioS test increased the efficiency of the diagnosis of SARS-CoV-2 infection in the early stages of the disease.

中文翻译：

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COVID19SEROSpeed IgM/IgG 快速检测的性能，一种用于诊断 SARS-CoV-2 感染的免疫层析检测：一项多中心欧洲研究

本研究评估了新型 COVID19SEROSpeed IgM/IgG 快速检测（BioSpeedia，巴黎巴斯德研究所的衍生产品）在检测严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 抗体方面的诊断性能，与其他检测方法相比通过大型跨欧洲调查进行商业抗体测定。对 215 份大流行前血清（包括一些来自病毒感染或自身免疫性疾病患者的血清）进行了临床特异性评估。对来自 564 名患者的 710 份血清进行了临床敏感性评估，这些患者通过定量逆转录 PCR (qRT-PCR) 证实了 SARS-CoV-2 感染，并将其抗体反应与其他五种商业测试测量的抗体反应进行了比较。还分析了七名有症状患者的抗体反应动力学。该测试 (BioS) 对大流行前样本的特异性为 98.1%（95% 置信区间 [CI]，96.2% 至 99.4%）。当对 710 个大流行样本进行测试时，BioS 显示总体临床敏感性为 86.0%（95% CI，0.83 至 0.89），与 Euroimmun 测定具有良好的一致性（总体一致性为 0.91；Cohen's kappa 系数为 0.62）。部分由于同时检测到 S1 和 N 蛋白的 IgM 和 IgG，BioS 在症状出现后 ≥11 天 (PSO) 表现出最高的阳性百分比一致性。总之，BioS IgM/IgG 快速检测具有高度特异性，并且比本研究中考虑的所有酶联免疫吸附测定/化学发光免疫测定 (ELISA/CLIA) 商业检测具有更高的阳性一致性百分比。此外，通过在 78.2% 的 PSO 前 11 天检测到抗体的存在，BioS 测试提高了疾病早期诊断 SARS-CoV-2 感染的效率。