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

K Bond; S Nicholson; SM Lim; T Karapanagiotidis; E Williams; D Johnson; T Hoang; C Sia; D Purcell; F Mordant; SR Lewin; M Catton; K Subbarao; BP Howden; DA Williamson

Journal article

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

K Bond, S Nicholson, SM Lim, T Karapanagiotidis, E Williams, D Johnson, T Hoang, C Sia, D Purcell, F Mordant, SR Lewin, M Catton, K Subbarao, BP Howden, DA Williamson

Journal of Infectious Diseases | OXFORD UNIV PRESS INC | Published : 2020

DOI: 10.1093/infdis/jiaa467

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 detect..

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University of Melbourne Researchers

Douglas Johnson Author

Damian Purcell Author

Francesca Mordant Author

Sharon Lewin Author

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Grants

Awarded by National Health and Medical Research Council

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).