Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use.
Antigen assay
COVID-19
Diagnostic
Rapid diagnostic test
SARS-CoV-2
Screening
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:
09 2021
09 2021
Historique:
received:
16
03
2021
revised:
07
07
2021
accepted:
14
07
2021
pubmed:
15
8
2021
medline:
18
9
2021
entrez:
14
8
2021
Statut:
ppublish
Résumé
Direct detection of SARS-CoV-2 viral proteins in nasopharyngeal swabs using lateral flow immunoassays is a simple, fast and cheap approach to diagnose the infection. The performance of 6 SARS-CoV-2 antigen rapid diagnostic tests has been assessed in 634 hospitalized patients or outpatients including 297 patients found to be positive for SARS-CoV-2 RNA by means of RT-PCR and 337 patients presumed to be SARS-CoV-2 RNA-negative. The specificity of SARS-CoV-2 RDTs was generally high (398.5%). One assay had a lower specificity of 93.2%. The overall sensitivity of the 6 RDTs was variable, from 32.3% to 61.7%. Sensitivity correlated with the delay of sampling after the onset of symptoms and the viral load estimated by the Ct value in RT-PCR. Four out of 6 RDTs tested achieved sensitivities 380% when clinical specimens were collected during the first 3 days following symptom onset or with a Ct value ≤25. The present study shows that SARS-CoV-2 antigen can be easily and reliably detected by RDTs. These tests are easy and rapid to perform. However, the specificity and sensitivity of COVID-19 antigen RDTs may widely vary across different tests and must therefore be carefully evaluated before releasing these assays for realworld applications.
Sections du résumé
BACKGROUND
Direct detection of SARS-CoV-2 viral proteins in nasopharyngeal swabs using lateral flow immunoassays is a simple, fast and cheap approach to diagnose the infection.
AIMS AND METHODS
The performance of 6 SARS-CoV-2 antigen rapid diagnostic tests has been assessed in 634 hospitalized patients or outpatients including 297 patients found to be positive for SARS-CoV-2 RNA by means of RT-PCR and 337 patients presumed to be SARS-CoV-2 RNA-negative.
RESULTS
The specificity of SARS-CoV-2 RDTs was generally high (398.5%). One assay had a lower specificity of 93.2%. The overall sensitivity of the 6 RDTs was variable, from 32.3% to 61.7%. Sensitivity correlated with the delay of sampling after the onset of symptoms and the viral load estimated by the Ct value in RT-PCR. Four out of 6 RDTs tested achieved sensitivities 380% when clinical specimens were collected during the first 3 days following symptom onset or with a Ct value ≤25.
CONCLUSIONS
The present study shows that SARS-CoV-2 antigen can be easily and reliably detected by RDTs. These tests are easy and rapid to perform. However, the specificity and sensitivity of COVID-19 antigen RDTs may widely vary across different tests and must therefore be carefully evaluated before releasing these assays for realworld applications.
Identifiants
pubmed: 34390929
pii: S1386-6532(21)00197-9
doi: 10.1016/j.jcv.2021.104930
pmc: PMC8310570
pii:
doi:
Substances chimiques
Antigens, Viral
0
RNA, Viral
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104930Informations de copyright
Copyright © 2021 Elsevier B.V. All rights reserved.
Références
JAMA. 2020 Aug 25;324(8):782-793
pubmed: 32648899
Clin Microbiol Infect. 2021 Feb;27(2):289.e1-289.e4
pubmed: 33031947
Euro Surveill. 2020 Jan;25(3):
pubmed: 31992387
J Clin Virol. 2020 Nov;132:104654
pubmed: 33053494
Nature. 2020 May;581(7809):465-469
pubmed: 32235945
Front Med (Lausanne). 2020 May 08;7:225
pubmed: 32574326
Chin Med J (Engl). 2020 May 5;133(9):1087-1095
pubmed: 32358325
N Engl J Med. 2020 Nov 26;383(22):e120
pubmed: 32997903
Int J Infect Dis. 2021 Mar;104:282-286
pubmed: 33130198
Virol J. 2020 Nov 13;17(1):177
pubmed: 33187528
J Clin Virol. 2020 Aug;129:104520
pubmed: 32652476