Evaluation of Serological Tests for SARS-CoV-2: Implications for Serology Testing in a Low-Prevalence Setting
Author
Bond, K; Nicholson, S; Lim, SM; Karapanagiotidis, T; Williams, E; Johnson, D; Hoang, T; Sia, C; Purcell, D; Mordant, F; ...Date
2020-10-15Source Title
Journal of Infectious DiseasesPublisher
OXFORD UNIV PRESS INCUniversity 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 ImmunologyDoherty Institute
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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
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https://europepmc.org/articles/PMC7454699?pdf=renderAbstract
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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