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    Evaluation of Serological Tests for SARS-CoV-2: Implications for Serology Testing in a Low-Prevalence Setting

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    Author
    Bond, K; Nicholson, S; Lim, SM; Karapanagiotidis, T; Williams, E; Johnson, D; Hoang, T; Sia, C; Purcell, D; Mordant, F; ...
    Date
    2020-10-15
    Source Title
    Journal of Infectious Diseases
    Publisher
    OXFORD UNIV PRESS INC
    University of Melbourne Author/s
    Purcell, Damian; Lewin, Sharon; Bond, Katherine; Mordant, Francesca; Nicholson, Suellen; Karapanagiotidis, Theo; Hoang, Tuyet; Sia, Cheryll; Catton, Michael; Subbarao, Kanta; ...
    Affiliation
    Microbiology and Immunology
    Doherty Institute
    Metadata
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    Document Type
    Journal Article
    Citations
    Bond, K., Nicholson, S., Lim, S. M., Karapanagiotidis, T., Williams, E., Johnson, D., Hoang, T., Sia, C., Purcell, D., Mordant, F., Lewin, S. R., Catton, M., Subbarao, K., Howden, B. P. & Williamson, D. A. (2020). Evaluation of Serological Tests for SARS-CoV-2: Implications for Serology Testing in a Low-Prevalence Setting. JOURNAL OF INFECTIOUS DISEASES, 222 (8), pp.1280-1288. https://doi.org/10.1093/infdis/jiaa467.
    Access Status
    Access this item via the Open Access location
    URI
    http://hdl.handle.net/11343/254385
    DOI
    10.1093/infdis/jiaa467
    Open Access URL
    https://europepmc.org/articles/PMC7454699?pdf=render
    Abstract
    BACKGROUND: Robust serological assays are essential for long-term control of the COVID-19 pandemic. Many recently released point-of-care (PoCT) serological assays have been distributed with little premarket validation. METHODS: Performance characteristics for 5 PoCT lateral flow devices approved for use in Australia were compared to a commercial enzyme immunoassay (ELISA) and a recently described novel surrogate virus neutralization test (sVNT). RESULTS: Sensitivities for PoCT ranged from 51.8% (95% confidence interval [CI], 43.1%-60.4%) to 67.9% (95% CI, 59.4%-75.6%), and specificities from 95.6% (95% CI, 89.2%-98.8%) to 100.0% (95% CI, 96.1%-100.0%). ELISA sensitivity for IgA or IgG detection was 67.9% (95% CI, 59.4%-75.6%), increasing to 93.8% (95% CI, 85.0%-98.3%) for samples >14 days post symptom onset. sVNT sensitivity was 60.9% (95% CI, 53.2%-68.4%), rising to 91.2% (95% CI, 81.8%-96.7%) for samples >14 days post symptom onset, with specificity 94.4% (95% CI, 89.2%-97.5%). CONCLUSIONS: Performance characteristics for COVID-19 serological assays were generally lower than those reported by manufacturers. Timing of specimen collection relative to onset of illness or infection is crucial in reporting of performance characteristics for COVID-19 serological assays. The optimal algorithm for implementing serological testing for COVID-19 remains to be determined, particularly in low-prevalence settings.

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