Evaluation of Serological Tests for SARS-CoV-2: Implications for Serology Testing in a Low-Prevalence Setting
AuthorBond, K; Nicholson, S; Lim, SM; Karapanagiotidis, T; Williams, E; Johnson, D; Hoang, T; Sia, C; Purcell, D; Mordant, F; ...
Source TitleJournal of Infectious Diseases
PublisherOXFORD UNIV PRESS INC
University of Melbourne Author/sPurcell, Damian; Lewin, Sharon; Bond, Katherine; Mordant, Francesca; Nicholson, Suellen; Karapanagiotidis, Theo; Hoang, Tuyet; Sia, Cheryll; Catton, Michael; Subbarao, Kanta; ...
AffiliationMicrobiology and Immunology
Document TypeJournal Article
CitationsBond, 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 StatusAccess this item via the Open Access location
Open Access URLPublished version
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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