An evaluation of 4 commercial assays for the detection of SARS-CoV-2 antibodies in a predominantly mildly symptomatic low prevalence Australian population.
Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Viral
/ blood
Australia
/ epidemiology
COVID-19
/ diagnosis
COVID-19 Serological Testing
/ methods
Child
Coronavirus Nucleocapsid Proteins
/ immunology
Female
Humans
Immunoglobulin Isotypes
/ blood
Male
Middle Aged
Phosphoproteins
/ immunology
Prevalence
Reagent Kits, Diagnostic
Sensitivity and Specificity
Seroepidemiologic Studies
Spike Glycoprotein, Coronavirus
/ immunology
Young Adult
Commercial immunoassay
Immunofluorescent antibody assay
Neutralising antibody
SARS-CoV-2 IgG
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
received:
22
12
2020
revised:
28
02
2021
accepted:
14
03
2021
pubmed:
27
3
2021
medline:
13
5
2021
entrez:
26
3
2021
Statut:
ppublish
Résumé
A total of 1080 individual patient samples (158 positive serology samples from confirmed, predominantly mildly symptomatic COVID-19 patients and 922 serology negative including 496 collected pre-COVID) from four states in Australia were analysed on four commercial SARS-CoV-2 serological assays targeting antibodies to different antigens (Roche Elecsys and Abbott Architect: nucleocapsid; Diasorin Liaison and Euroimmun: spike). A subset was compared to immunofluorescent antibody (IFA) and micro-neutralisation. Sensitivity and specificity of the Roche (n = 1033), Abbott (n = 806), Diasorin (n = 1034) and Euroimmun (n = 175) were 93.7 %/99.5 %, 90.2 %/99.4 %, 88.6 %/98.6 % and 91.3 %/98.8 %, respectively. ROC analysis with specificity held at 99 % increased the sensitivity for the Roche and Abbott assays from 93.7% to 98.7% (cut-off 0.21) and 90.2 % to 94.0 % (cut-off 0.91), respectively. Overall seropositivity of samples increased from a maximum of 23 % for samples 0-7 days-post-onset of symptoms (dpos), to 61 % from samples 8-14dpos and 93 % from those >14dpos. IFA and microneutralisation values correlated best with assays targeting antibodies to spike protein with values >80 AU/mL on the Diasorin assay associated with neutralising antibody. Detectable antibody was present in 22/23 (96 %), 20/23 (87 %), 15/23 (65 %) and 9/22 (41 %) patients with samples >180dpos on the Roche, Diasorin, Abbott and microneutralisation assays respectively. Given the low prevalence in this community, two-step algorithms on initial positive results saw an increase in the positive predictive value (PPV) of positive samples (39 %-65 % to ≥98 %) for all combinations. Similarly accuracy increased from a range of 98.5 %-99.4 % to ≥99.8 % assuming a 1 % seroprevalence. Negative predictive value (NPV) was high (≥99.8 %) regardless of which assay was used initially.
Identifiants
pubmed: 33770657
pii: S1386-6532(21)00064-0
doi: 10.1016/j.jcv.2021.104797
pmc: PMC7968170
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Coronavirus Nucleocapsid Proteins
0
Immunoglobulin Isotypes
0
Phosphoproteins
0
Reagent Kits, Diagnostic
0
Spike Glycoprotein, Coronavirus
0
nucleocapsid phosphoprotein, SARS-CoV-2
0
spike protein, SARS-CoV-2
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104797Informations de copyright
Copyright © 2021 Elsevier B.V. All rights reserved.
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