Evaluation of serological tests for SARS-CoV-2: Implications for serology testing in a low-prevalence setting release_7fwzwudbrnh75jqfjcsgwze4cq

by Katherine Bond, Suellen Nicholson, Seok Lim, Theo Karapanagiotidis, Eloise Williams, Douglas Johnston, Tuyet Hoang, Cheryll Sia, Damian Purcell, Sharon Lewin, Mike Catton, Benjamon P Howden (+1 others)

Released as a post by Cold Spring Harbor Laboratory.



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 pre-market validation. Methods: Performance characteristics for five PoCT lateral flow devices approved for use in Australia were compared to a commercial enzyme immunoassay (ELISA) and a recently described novel surrogate virus neutralisation test (sVNT). Results: Sensitivities for PoCT ranged from 51.8% (95% CI 43.1 to 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%). Overall ELISA sensitivity for either 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. Overall, sVNT sensitivity was 60.9% (95% CI 53.2-68.4%), rising to 91.2%% (95% CI 81.8-96.7%) for samples collected >14 days post-symptom onset, with a specificity 94.4% (95% CI 89.2-97.5%), Conclusion: 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 the 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.
In application/xml+jats format

Archived Files and Locations

application/pdf  198.9 kB
www.medrxiv.org (repository)
web.archive.org (webarchive)
Read Archived PDF
Preserved and Accessible
Type  post
Stage   unknown
Date   2020-06-03
Work Entity
access all versions, variants, and formats of this works (eg, pre-prints)
Catalog Record
Revision: 6aef1862-1878-4a9a-b8c5-78f5f6149562