Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: Two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech).
Aged
Antibodies, Viral
/ blood
Automation, Laboratory
/ methods
Betacoronavirus
/ immunology
COVID-19
COVID-19 Testing
Clinical Laboratory Techniques
/ methods
Coronavirus Infections
/ diagnosis
Female
Humans
Immunoassay
/ methods
Immunoglobulin A
/ blood
Immunoglobulin G
/ blood
Male
Middle Aged
Pandemics
Pneumonia, Viral
/ diagnosis
Retrospective Studies
SARS-CoV-2
Sensitivity and Specificity
Serologic Tests
/ methods
Time Factors
Automated immunoassays
COVID-19
Lateral flow immunoassay
Performance
SARS-CoV-2
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:
08 2020
08 2020
Historique:
received:
12
06
2020
accepted:
14
06
2020
pubmed:
28
6
2020
medline:
12
8
2020
entrez:
28
6
2020
Statut:
ppublish
Résumé
The emergence of new SARS-CoV-2 has promoted the development of new serological tests that could be complementary to RT-PCR. Nevertheless, the assessment of clinical performances of available tests is urgently required as their use has just been initiated for diagnose. The aim of this study was to assess the performance of three immunoassays for the detection of SARS-CoV-2 antibodies. Two automated immunoassays (Abbott SARS-CoV-2 CLIA IgG and Euroimmun Anti-SARS-CoV-2 ELISA IgG/IgA assays) and one lateral flow immunoassay (LFIA NG-Test® IgG-IgM COVID-19) were tested. 293 specimens were analyzed from patients with a positive RT-PCR response, from patients with symptoms consistent with COVID-19 but exhibiting a negative response to the RT-PCR detection test, and from control group specimens. Days since symptoms onset were collected from clinical information sheet associated with respiratory tract samples. Overall sensitivity for IgG was equivalent (around 80 %) for CLIA, ELISA and LFIA. Sensitivity for IgG detection, >14 days after onset of symptoms, was 100.0 % for all assays. Overall specificity for IgG was greater for CLIA and LFIA (more than 98 %) compared to ELISA (95.8 %). Specificity was significantly different between IgA ELISA (78.9 %) and IgM LFIA (95.8 %) (p < 0.05). The best agreement was observed between CLIA and LFIA assays (97 %; k = 0.936). Excellent sensitivity for IgG detection was obtained >14 days after onset of symptoms for all immunoassays. Specificity was also excellent for IgG CLIA and IgG LFIA. Our study shows that NG-Test® is reliable and accurate for routine use in clinical laboratories.
Sections du résumé
BACKGROUND
The emergence of new SARS-CoV-2 has promoted the development of new serological tests that could be complementary to RT-PCR. Nevertheless, the assessment of clinical performances of available tests is urgently required as their use has just been initiated for diagnose.
OBJECTIVES
The aim of this study was to assess the performance of three immunoassays for the detection of SARS-CoV-2 antibodies.
METHODS
Two automated immunoassays (Abbott SARS-CoV-2 CLIA IgG and Euroimmun Anti-SARS-CoV-2 ELISA IgG/IgA assays) and one lateral flow immunoassay (LFIA NG-Test® IgG-IgM COVID-19) were tested. 293 specimens were analyzed from patients with a positive RT-PCR response, from patients with symptoms consistent with COVID-19 but exhibiting a negative response to the RT-PCR detection test, and from control group specimens. Days since symptoms onset were collected from clinical information sheet associated with respiratory tract samples.
RESULTS
Overall sensitivity for IgG was equivalent (around 80 %) for CLIA, ELISA and LFIA. Sensitivity for IgG detection, >14 days after onset of symptoms, was 100.0 % for all assays. Overall specificity for IgG was greater for CLIA and LFIA (more than 98 %) compared to ELISA (95.8 %). Specificity was significantly different between IgA ELISA (78.9 %) and IgM LFIA (95.8 %) (p < 0.05). The best agreement was observed between CLIA and LFIA assays (97 %; k = 0.936).
CONCLUSION
Excellent sensitivity for IgG detection was obtained >14 days after onset of symptoms for all immunoassays. Specificity was also excellent for IgG CLIA and IgG LFIA. Our study shows that NG-Test® is reliable and accurate for routine use in clinical laboratories.
Identifiants
pubmed: 32593133
pii: S1386-6532(20)30253-5
doi: 10.1016/j.jcv.2020.104511
pmc: PMC7295485
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin A
0
Immunoglobulin G
0
Types de publication
Comparative Study
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
104511Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no conflict of interest.
Références
Clin Chem. 2020 Aug 1;66(8):1055-1062
pubmed: 32402061
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32513859
J Med Virol. 2020 Oct;92(10):2243-2247
pubmed: 32510168
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32381641
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32518071
Emerg Microbes Infect. 2020 Dec;9(1):833-836
pubmed: 32306864
Lancet. 2020 Apr 4;395(10230):1101-1102
pubmed: 32247384
Emerg Microbes Infect. 2020 Dec;9(1):924-927
pubmed: 32286155
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32245835
Radiology. 2020 Aug;296(2):E41-E45
pubmed: 32049601
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32277023
N Engl J Med. 2020 Feb 20;382(8):727-733
pubmed: 31978945
N Engl J Med. 2020 Aug 6;383(6):e37
pubmed: 32501664
Diagnostics (Basel). 2020 Apr 05;10(4):
pubmed: 32260471
Malays J Pathol. 2020 Apr;42(1):13-21
pubmed: 32342927
Cell Immunol. 2020 Jul;353:104114
pubmed: 32361409
J Clin Virol. 2020 Aug;129:104480
pubmed: 32505777
Lancet Infect Dis. 2020 Jul;20(7):758-759
pubmed: 32330441
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32229605
Lancet Infect Dis. 2020 Jun;20(6):697-706
pubmed: 32224310
Emerg Infect Dis. 2020 Jul;26(7):1478-1488
pubmed: 32267220
J Clin Virol. 2020 Jul;128:104413
pubmed: 32403010
JAMA. 2020 Jun 9;323(22):2249-2251
pubmed: 32374370
Clin Microbiol Infect. 2020 Aug;26(8):1082-1087
pubmed: 32473953
Lancet Respir Med. 2020 May;8(5):475-481
pubmed: 32105632
Nat Rev Immunol. 2020 Jun;20(6):363-374
pubmed: 32346093
J Infect. 2020 Jul;81(1):e28-e32
pubmed: 32283141
Emerg Microbes Infect. 2020 Dec;9(1):747-756
pubmed: 32196430