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    Mar 04, 2021
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    Evaluating Ten Commercially-Available SARS-CoV-2 Rapid Serological Tests Using the STARD (Standards for Reporting of Diagnostic Accuracy Studies) Method.

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    Dortet et al 2020 Evaluating Ten ...
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    Authors
    Dortet, L
    Ronat, JB
    Vauloup-Fellous, C
    Langendorf, C
    Mendels, DA
    Emeraud, C
    Oueslati, S
    Girlich, D
    Chauvin, A
    Afdjei, A
    Bernabeu, S
    Le Pape, S
    Kallala, R
    Rochard, A
    Verstuyft, C
    Fortineau, N
    Roque-Afonso, AM
    Naas, T
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    Issue Date
    2020-11-25
    Submitted date
    2021-01-14
    
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    Journal
    Journal of Clinical Microbiology
    Abstract
    Numerous SARS-CoV-2 rapid serological tests have been developed, but their accuracy has usually been assessed using very few samples, and rigorous comparisons between these tests are scarce. In this study, we evaluated and compared 10 commercially-available SARS-CoV-2 rapid serological tests using the STARD methodology (Standards for Reporting of Diagnostic Accuracy Studies). 250 sera from 159 PCR-confirmed SARS-CoV-2 patients (collected from 0 to 32 days after onset of symptoms) were tested with rapid serological tests. Control sera (N = 254) were retrieved from pre-COVID periods from patients with other coronavirus infections (N = 11), positive rheumatoid factors (N = 3), IgG/IgM hyperglobulinemia (N = 9), malaria (n = 5), or no documented viral infection (N = 226). All samples were tested using rapid lateral flow immunoassays (LFIA) from 10 manufacturers. Only four tests achieved ≥98% specificity, with other tests ranging from 75.7%-99.2%. Sensitivities varied by the day of sample collection, from 31.7%-55.4% (Days 0-9), 65.9%-92.9% (Days 10-14), and 81.0%-95.2% (>14 days) after the onset of symptoms, respectively. Only three tests evaluated met French Health Authorities’ thresholds for SARS-CoV-2 serological tests (≥90% sensitivity + ≥98% specificity). Overall, the performances between tests varied greatly, with only a third meeting acceptable specificity and sensitivity thresholds. Knowing the analytical performance of these tests will allow clinicians and most importantly laboratorians to use them with more confidence, could help determine the general population’s immunological status, and may help to diagnose some patients with false-negative RT-PCR results.
    Publisher
    American Society for Microbiology
    URI
    http://hdl.handle.net/10144/619818
    Language
    en
    Collections
    COVID-19

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