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*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

46 Citations (Scopus)

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 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.

Original languageEnglish
Pages (from-to)1280-1288
Number of pages9
JournalJournal of Infectious Diseases
Volume222
Issue number8
DOIs
Publication statusPublished - 15 Oct 2020
Externally publishedYes

Bibliographical note

Publisher Copyright:
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.

Keywords

  • COVID-19
  • ELISA
  • Lateral flow
  • Neutralization
  • Serology

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