TY - JOUR
T1 - Evaluation of serological tests for SARS-CoV-2
T2 - Implications for serology testing in a low-prevalence setting
AU - Bond, Katherine
AU - Nicholson, Suellen
AU - Lim, Seok Ming
AU - Karapanagiotidis, Theo
AU - Williams, Eloise
AU - Johnson, Douglas
AU - Hoang, Tuyet
AU - Sia, Cheryll
AU - Purcell, Damian
AU - Mordant, Francesca
AU - Lewin, Sharon R.
AU - Catton, Mike
AU - Subbarao, Kanta
AU - Howden, Benjamin P.
AU - Williamson, Deborah A.
N1 - Publisher Copyright:
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.
PY - 2020/10/15
Y1 - 2020/10/15
N2 - 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.
AB - 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.
KW - COVID-19
KW - ELISA
KW - Lateral flow
KW - Neutralization
KW - Serology
UR - http://www.scopus.com/inward/record.url?scp=85089604700&partnerID=8YFLogxK
U2 - 10.1093/infdis/jiaa467
DO - 10.1093/infdis/jiaa467
M3 - Article
C2 - 32761124
AN - SCOPUS:85089604700
SN - 0022-1899
VL - 222
SP - 1280
EP - 1288
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 8
ER -