Evaluating ELISA, Immunofluorescence, and Lateral Flow Assay for SARS-CoV-2 Serologic Assays.
COVID-19 – diagnosis – ELISA – human – IgG antibodies – SARS-CoV-2 – standardization
ELISA
IgG serology
IgM serology
indirect immunofluorescence
lateral flow assay
Journal
Frontiers in microbiology
ISSN: 1664-302X
Titre abrégé: Front Microbiol
Pays: Switzerland
ID NLM: 101548977
Informations de publication
Date de publication:
2020
2020
Historique:
received:
21
08
2020
accepted:
12
11
2020
entrez:
28
12
2020
pubmed:
29
12
2020
medline:
29
12
2020
Statut:
epublish
Résumé
The SARS-CoV-2 outbreak has emerged at the end of 2019. Aside from the detection of viral genome with specific RT-PCR, there is a growing need for reliable determination of the serological status. We aimed at evaluating five SARS-CoV-2 serology assays. An in-house immunofluorescence assay (IFA), two ELISA kits (EUROIMMUN Control subjects tested negative for SARS-CoV-2 antibodies with all five systems. Estimated sensitivities varied from 35.5 to 71.0% for IgG detection and from 19.4 to 64.5% for IgM detection. For IgG, in-house IFA, EuroImmun, T-Tek and NovaLisa displayed 50-72.5% agreement with other systems except IFA vs EuroImmun and T-Tek vs NovaLisa. Intermethod agreement for IgM determination was between 30 and 72.5%. The overall intermethod agreement was moderate. This inconsistency could be explained by the diversity of assay methods, antigens used and immunoglobulin isotype tested. Estimated sensitivities were low, highlighting the limited value of antibody detection in CoVID-19. Comparison of five systems for SARS-CoV-2 IgG and IgM antibodies showed limited sensitivity and overall concordance. The place and indications of serological status assessment with currently available tools in the CoVID-19 pandemic need further evaluations.
Sections du résumé
BACKGROUND
BACKGROUND
The SARS-CoV-2 outbreak has emerged at the end of 2019. Aside from the detection of viral genome with specific RT-PCR, there is a growing need for reliable determination of the serological status. We aimed at evaluating five SARS-CoV-2 serology assays.
METHODS
METHODS
An in-house immunofluorescence assay (IFA), two ELISA kits (EUROIMMUN
RESULTS
RESULTS
Control subjects tested negative for SARS-CoV-2 antibodies with all five systems. Estimated sensitivities varied from 35.5 to 71.0% for IgG detection and from 19.4 to 64.5% for IgM detection. For IgG, in-house IFA, EuroImmun, T-Tek and NovaLisa displayed 50-72.5% agreement with other systems except IFA vs EuroImmun and T-Tek vs NovaLisa. Intermethod agreement for IgM determination was between 30 and 72.5%.
DISCUSSION
CONCLUSIONS
The overall intermethod agreement was moderate. This inconsistency could be explained by the diversity of assay methods, antigens used and immunoglobulin isotype tested. Estimated sensitivities were low, highlighting the limited value of antibody detection in CoVID-19.
CONCLUSION
CONCLUSIONS
Comparison of five systems for SARS-CoV-2 IgG and IgM antibodies showed limited sensitivity and overall concordance. The place and indications of serological status assessment with currently available tools in the CoVID-19 pandemic need further evaluations.
Identifiants
pubmed: 33362745
doi: 10.3389/fmicb.2020.597529
pmc: PMC7759487
doi:
Types de publication
Journal Article
Langues
eng
Pagination
597529Informations de copyright
Copyright © 2020 Michel, Bouam, Edouard, Fenollar, Di Pinto, Mège, Drancourt and Vitte.
Déclaration de conflit d'intérêts
The two ELISA kits and lateral flow assays were kindly provided by suppliers for evaluation. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Références
Clin Transl Immunology. 2020 May 06;9(5):e01136
pubmed: 32382418
J Clin Virol. 2020 Aug;129:104511
pubmed: 32593133
J Pharm Anal. 2020 Apr;10(2):102-108
pubmed: 32282863
J Immunol. 2020 Aug 1;205(3):555-564
pubmed: 32513850
J Clin Virol. 2020 Aug;129:104455
pubmed: 32485618
J Infect Dis. 2020 Jul 6;222(3):362-366
pubmed: 32473021
Emerg Infect Dis. 2020 Jul;26(7):1478-1488
pubmed: 32267220
Clin Sci (Lond). 2017 Jun 30;131(14):1737-1762
pubmed: 28667071
Clin Microbiol Infect. 2020 Aug;26(8):1082-1087
pubmed: 32473953
CMAJ. 2004 Jan 6;170(1):47-54
pubmed: 14707219
Clin Infect Dis. 2020 Nov 19;71(16):2027-2034
pubmed: 32221519
Clin Infect Dis. 2020 Nov 19;71(16):2255-2258
pubmed: 32337590
Travel Med Infect Dis. 2020 Jul - Aug;36:101632
pubmed: 32205269
Clin Microbiol Infect. 2020 Nov;26(11):1557.e1-1557.e7
pubmed: 32745595
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32513859
J Clin Virol. 2020 Aug;129:104468
pubmed: 32485620
Lancet. 2020 Mar 28;395(10229):1054-1062
pubmed: 32171076
Clin Microbiol Infect. 2008 Dec;14(12):1112-8
pubmed: 19076842
J Infect. 2020 Aug;81(2):e39-e45
pubmed: 32504735
Clin Infect Dis. 2020 Jul 28;71(15):778-785
pubmed: 32198501
Cell Mol Immunol. 2020 Jul;17(7):773-775
pubmed: 32467617
Immunity. 2020 Jun 16;52(6):910-941
pubmed: 32505227
Diagn Microbiol Infect Dis. 2017 Oct;89(2):106-111
pubmed: 28821364
Eur J Clin Microbiol Infect Dis. 2020 Nov 11;:
pubmed: 33179133
J Med Virol. 2020 Sep;92(9):1518-1524
pubmed: 32104917
Clin Infect Dis. 2020 May 30;:
pubmed: 32472684
N Engl J Med. 2020 Oct 8;383(15):1492-1494
pubmed: 32937062
J Clin Virol. 2020 Aug;129:104480
pubmed: 32505777
Allergy. 2020 Jul;75(7):1730-1741
pubmed: 32077115
Immunity. 2020 Jul 14;53(1):98-105.e5
pubmed: 32561270
Cell. 2020 Apr 16;181(2):271-280.e8
pubmed: 32142651
Immunity. 2020 Jun 16;52(6):971-977.e3
pubmed: 32413330
Nature. 2020 May;581(7807):215-220
pubmed: 32225176
J Mol Diagn. 2020 Jun;22(6):729-735
pubmed: 32276051