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Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study.
Plebani, Mario; Parcina, Marijo; Bechri, Issam; Zehender, Gianguglielmo; Terkes, Vedrana; Abdel Hafith, Balqis; Antinori, Spinello; Pillet, Sylvie; Gonzalo, Sylvie; Hoerauf, Achim; Lai, Alessia; Morovic, Miro; Bourlet, Thomas; Torre, Alessandro; Pozzetto, Bruno; Galli, Massimo.
  • Plebani M; Department of Medicine-DIMED, University of Padova, Padua, Italy.
  • Parcina M; Department of Laboratory Medicine, University Hospital of Padova, Padua, Italy.
  • Bechri I; Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Bonn, Germany.
  • Zehender G; Department of Infectious Agents and Hygiene, University Hospital of Saint-Etienne, Saint-Etienne, France.
  • Terkes V; Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milan, Italy.
  • Abdel Hafith B; Department of Infectious Diseases, Zadar Regional Hospital, Zadar, Croatia.
  • Antinori S; Department of Medicine-DIMED, University of Padova, Padua, Italy.
  • Pillet S; Department of Laboratory Medicine, University Hospital of Padova, Padua, Italy.
  • Gonzalo S; Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milan, Italy.
  • Hoerauf A; Department of Infectious Agents and Hygiene, University Hospital of Saint-Etienne, Saint-Etienne, France.
  • Lai A; GIMAP EA3064, Faculty of Medicine, University Jean Monnet of Saint-Etienne, Saint-Etienne, France.
  • Morovic M; Department of Infectious Agents and Hygiene, University Hospital of Saint-Etienne, Saint-Etienne, France.
  • Bourlet T; Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Bonn, Germany.
  • Torre A; Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milan, Italy.
  • Pozzetto B; Department of Infectious Diseases, Zadar Regional Hospital, Zadar, Croatia.
  • Galli M; Department of Infectious Agents and Hygiene, University Hospital of Saint-Etienne, Saint-Etienne, France.
J Clin Microbiol ; 59(2)2021 01 21.
Article in English | MEDLINE | ID: covidwho-1066814
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: Europa Language: English Year: 2021 Document Type: Article Affiliation country: JCM.02240-20

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: Europa Language: English Year: 2021 Document Type: Article Affiliation country: JCM.02240-20