• J. Clin. Virol. · Aug 2020

    Comparative Study

    Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: Two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech).

    • Thomas Nicol, Caroline Lefeuvre, Orianne Serri, Adeline Pivert, Françoise Joubaud, Vincent Dubée, Achille Kouatchet, Alexandra Ducancelle, Françoise Lunel-Fabiani, and Hélène Le Guillou-Guillemette.
    • Virology Department, Angers University Hospital, Angers, France.
    • J. Clin. Virol. 2020 Aug 1; 129: 104511.

    BackgroundThe emergence of new SARS-CoV-2 has promoted the development of new serological tests that could be complementary to RT-PCR. Nevertheless, the assessment of clinical performances of available tests is urgently required as their use has just been initiated for diagnose.ObjectivesThe aim of this study was to assess the performance of three immunoassays for the detection of SARS-CoV-2 antibodies.MethodsTwo automated immunoassays (Abbott SARS-CoV-2 CLIA IgG and Euroimmun Anti-SARS-CoV-2 ELISA IgG/IgA assays) and one lateral flow immunoassay (LFIA NG-Test® IgG-IgM COVID-19) were tested. 293 specimens were analyzed from patients with a positive RT-PCR response, from patients with symptoms consistent with COVID-19 but exhibiting a negative response to the RT-PCR detection test, and from control group specimens. Days since symptoms onset were collected from clinical information sheet associated with respiratory tract samples.ResultsOverall sensitivity for IgG was equivalent (around 80 %) for CLIA, ELISA and LFIA. Sensitivity for IgG detection, >14 days after onset of symptoms, was 100.0 % for all assays. Overall specificity for IgG was greater for CLIA and LFIA (more than 98 %) compared to ELISA (95.8 %). Specificity was significantly different between IgA ELISA (78.9 %) and IgM LFIA (95.8 %) (p < 0.05). The best agreement was observed between CLIA and LFIA assays (97 %; k = 0.936).ConclusionExcellent sensitivity for IgG detection was obtained >14 days after onset of symptoms for all immunoassays. Specificity was also excellent for IgG CLIA and IgG LFIA. Our study shows that NG-Test® is reliable and accurate for routine use in clinical laboratories.Copyright © 2020 Elsevier B.V. All rights reserved.

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