Clinical evaluation of commercial automated SARS-CoV-2 immunoassays.
Automated SARS-CoV-2 antibody detection
High throughpu testing
Longitudional monitoring of antibody development
Pandemic control
Seroconversion
Serpprevalence
Journal
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
ISSN: 1878-3511
Titre abrégé: Int J Infect Dis
Pays: Canada
ID NLM: 9610933
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
09
09
2020
revised:
30
11
2020
accepted:
02
12
2020
pubmed:
15
12
2020
medline:
17
2
2021
entrez:
14
12
2020
Statut:
ppublish
Résumé
Numerous immunoassays for detecting antibodies directed against SARS-CoV-2 have been rapidly developed and released. Validations of these have been performed with a limited number of samples. The lack of standardisation might lead to significantly different results. This study compared ten automated assays from six vendors in terms of sensitivity, specificity and reproducibility. This study compared ten fully automated immunoassays from the following vendors: Diasorin, Epitope Diagnostics, Euroimmun, Roche, YHLO, and Snibe. The retrospective part of the study included patients with a laboratory-confirmed COVID-19 infection, and controls comprised patients with a suspected infection, in whom the disease was excluded. Furthermore, biobanked sera were taken as negative controls (n = 97). The retrospective part involved four groups: (1) laboratory-confirmed COVID-19 infection (n = 183); (1B) suspected COVID-19 infection (n = 167) without a qRT-PCR result but positive serological results from at least two different assays, and suspected COVID-19 infection due to a positive serological result from the Roche assay (n = 295); (2) biobanked sera obtained from patients before the emergence of SARS-CoV-2 (n = 97) as negative controls; and (2A) probably COVID-19-negative sera with negative serological results from at least two different assays (n = 152). Overall diagnostic sensitivities were: Euroimmun (IgA) 87%; Epitope Diagnostics (IgG) 83%; YHLO (IgG) 77%; Roche (IgM/IgG) 77%; Euroimmun (IgG) 75%; Diasorin (IgG) 53%; Epitope Diagnostics (IgM) 52%; Snibe (IgG) 47%; YHLO (IgM) 35%; and Snibe (IgM) 26%. Diagnostic specificities were: YHLO (IgG) 100%; Roche, 100%; Snibe (IgM/IgG) 100%; Diasorin (IgG) 97%; Euroimmun (IgG) 94%; YHLO (IgM) 94%; Euroimmun (IgA) 83%. Assays from different vendors substantially varied in terms of their performance. These findings might facilitate selection of appropriate serological assays.
Identifiants
pubmed: 33310108
pii: S1201-9712(20)32526-1
doi: 10.1016/j.ijid.2020.12.003
pmc: PMC7725057
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin G
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
590-596Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
Références
Clin Infect Dis. 2020 Nov 19;71(16):2027-2034
pubmed: 32221519
Viruses. 2020 May 26;12(6):
pubmed: 32466458
Rev Med Virol. 2020 May;30(3):e2106
pubmed: 32302058
Sci Immunol. 2020 May 19;5(47):
pubmed: 32430309
J Med Virol. 2020 Oct;92(10):2243-2247
pubmed: 32510168
Nat Med. 2020 Jun;26(6):845-848
pubmed: 32350462
Nature. 2020 May;581(7809):465-469
pubmed: 32235945
Eur Respir J. 2020 Aug 27;56(2):
pubmed: 32430429
J Clin Virol. 2020 Jul;128:104394
pubmed: 32416599
J Clin Virol. 2020 Aug;129:104540
pubmed: 32652475
J Clin Virol. 2020 Jul;128:104413
pubmed: 32403010
Clin Chem. 2020 Jul 1;66(7):875-877
pubmed: 32343775
J Med Virol. 2020 Oct;92(10):1812-1817
pubmed: 32347966
Emerg Microbes Infect. 2020 Dec;9(1):747-756
pubmed: 32196430
Nat Med. 2020 Apr;26(4):453-455
pubmed: 32284614
Cell. 2020 Aug 20;182(4):843-854.e12
pubmed: 32673567
J Clin Virol. 2020 Aug;129:104511
pubmed: 32593133
Clin Infect Dis. 2020 Jul 28;71(15):778-785
pubmed: 32198501
mBio. 2020 Mar 26;11(2):
pubmed: 32217609
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32350047
J Clin Virol. 2020 Aug;129:104480
pubmed: 32505777
Ann Intern Med. 2020 Jun 2;172(11):726-734
pubmed: 32282894
Lancet Infect Dis. 2020 Jul;20(7):758-759
pubmed: 32330441
BMJ. 2020 Jul 1;370:m2516
pubmed: 32611558
Microbes Infect. 2020 May - Jun;22(4-5):206-211
pubmed: 32425648
Lancet Infect Dis. 2020 May;20(5):565-574
pubmed: 32213337
Lancet Respir Med. 2020 Dec;8(12):1167-1168
pubmed: 33007240
Emerg Infect Dis. 2020 Jul;26(7):1478-1488
pubmed: 32267220
Biochem Med (Zagreb). 2017 Feb 15;27(1):37-48
pubmed: 28392725
Clin Chim Acta. 2020 Oct;509:1-7
pubmed: 32485157
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32245835
Emerg Microbes Infect. 2020 Dec;9(1):386-389
pubmed: 32065057
Science. 2020 Jun 5;368(6495):1060-1061
pubmed: 32414781