This study assessed the diagnostic performance of the new coronavirus disease 2019 (COVID-19) SEROSpeed 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). ABSTRACT 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.
【저자키워드】 COVID-19, SARS-CoV-2, serology, Rapid test, immunochromatographic assay, multicenter, 【초록키워드】 coronavirus disease, viral infection, Coronavirus disease 2019, coronavirus, pandemic, antibody, SARS-COV-2 infection, Antibody Response, qRT-PCR, Infection, Test, diagnostic, severe acute respiratory syndrome Coronavirus, viral infections, reverse transcription-PCR, immunoassay, specificity, enzyme-linked immunosorbent assay, Kinetics, Viral, Symptomatic patients, Concordance, Rapid test, IgM/IgG, chemiluminescence immunoassay, sera, Patient, Rapid, antibody assay, respiratory, disease, Quantitative, specimens, early stage, patients, New coronavirus, Autoimmune disorders, PSO, Efficiency, clinical sensitivity, IgM and IgG, Pasteur Institute, acute respiratory syndrome, 95% CI, acute respiratory syndrome coronavirus, Cohen’s kappa coefficient, acute respiratory syndrome coronavirus 2, 95% confidence interval, enzyme, post-symptom onset, Paris, clinical specificity, specimen, early stages, positive, N proteins, Kappa coefficient, overall concordance, FIVE, enzyme-linked immunosorbent, Seven, highest, tested, analyzed, the disease, evaluated, exhibited, demonstrated, presence of antibody, the antibody response, diagnosis of SARS-CoV-2, 【제목키워드】 Test, Rapid test, IgM/IgG, Rapid, performance, European,