Journal article

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

Katherine Bond, Suellen Nicholson, Seok Ming Lim, Theo Karapanagiotidis, Eloise Williams, Douglas Johnson, Tuyet Hoang, Cheryll Sia, Damian Purcell, Francesca Mordant, Sharon R Lewin, Mike Catton, Kanta Subbarao, Benjamin P Howden, Deborah A Williamson



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 detect..

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Awarded by National Health and Medical Research Council (NHMRC) of Australia Medical Research Future Fund

Awarded by NHMRC

Awarded by NHMRC Postgraduate Scholarship

Funding Acknowledgements

This work was supported by the National Health and Medical Research Council (NHMRC) of Australia Medical Research Future Fund (grant number APP2002317); the Jack Ma Foundation (grant to K. S.); and the A2 Milk Company (grant to K. S.). The Melbourne World Health Organization Collaborating Centre for Reference and Research on Influenza is supported by the Australian Government Department of Health. D. A. W. and K. S. are supported by Investigator Grants from the NHMRC (grant numbers APP1174555 and APP1177174, respectively). B. P. H. is supported by a NHMRC Practitioner Fellowship (grant number APP1105905). K. B. is supported by an NHMRC Postgraduate Scholarship (grant number GNT1191321).