Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR.
Antigen rapid diagnostic test
COVID-19
Clinical evaluation
PCR
Performance evaluation
SARS-CoV-2
Journal
EBioMedicine
ISSN: 2352-3964
Titre abrégé: EBioMedicine
Pays: Netherlands
ID NLM: 101647039
Informations de publication
Date de publication:
Jul 2021
Jul 2021
Historique:
received:
16
04
2021
revised:
07
06
2021
accepted:
07
06
2021
pubmed:
30
6
2021
medline:
6
8
2021
entrez:
29
6
2021
Statut:
ppublish
Résumé
Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse. In a prospective performance evaluation study, RDT from three manufacturers (NADAL®, Panbio™, MEDsan®, conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C The sensitivity of RDT compared to RT-qPCR was 42·57% (95% CI 33·38%-52·31%). The specificity was 99·68% (95% CI 99·48%-99·80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of ≥10 RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available. German Federal Ministry for Education and Science (BMBF), Free State of Bavaria.
Sections du résumé
BACKGROUND
BACKGROUND
Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse.
METHODS
METHODS
In a prospective performance evaluation study, RDT from three manufacturers (NADAL®, Panbio™, MEDsan®, conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C
FINDINGS
RESULTS
The sensitivity of RDT compared to RT-qPCR was 42·57% (95% CI 33·38%-52·31%). The specificity was 99·68% (95% CI 99·48%-99·80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of ≥10
INTERPRETATION
CONCLUSIONS
RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available.
FUNDING
BACKGROUND
German Federal Ministry for Education and Science (BMBF), Free State of Bavaria.
Identifiants
pubmed: 34186490
pii: S2352-3964(21)00248-6
doi: 10.1016/j.ebiom.2021.103455
pmc: PMC8234263
pii:
doi:
Substances chimiques
Reagent Kits, Diagnostic
0
Spike Glycoprotein, Coronavirus
0
spike protein, SARS-CoV-2
0
Types de publication
Comparative Study
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
103455Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest None of the authors has any conflict of interest.
Références
J Pediatr. 2021 May;232:287-289.e4
pubmed: 33484697
EBioMedicine. 2021 Feb;64:103230
pubmed: 33530000
Euro Surveill. 2020 Jan;25(3):
pubmed: 31992387
JAMA Otolaryngol Head Neck Surg. 2020 Dec 1;146(12):1179-1181
pubmed: 33022069
Euro Surveill. 2021 Jan;26(1):
pubmed: 33413742
Nature. 2020 May;581(7809):465-469
pubmed: 32235945
PLoS One. 2021 Mar 31;16(3):e0248921
pubmed: 33788882
Clin Microbiol Infect. 2021 Mar;27(3):472.e7-472.e10
pubmed: 33189872
J Infect Dis. 2021 May 20;223(9):1528-1537
pubmed: 33585934
J Clin Virol. 2021 Apr;137:104782
pubmed: 33711691
Clin Chem Lab Med. 2021 Apr 28;59(9):1507-1515
pubmed: 33908222
MMWR Morb Mortal Wkly Rep. 2021 Jan 22;70(3):95-99
pubmed: 33476315
Open Forum Infect Dis. 2021 May 12;8(6):ofab235
pubmed: 34095340
J Med Virol. 2021 May;93(5):2890-2898
pubmed: 33386772
J Clin Med. 2021 Jan 17;10(2):
pubmed: 33477365
Microorganisms. 2020 Dec 28;9(1):
pubmed: 33379279
Lancet Microbe. 2021 Jul;2(7):e311-e319
pubmed: 33846704
J Infect. 2021 May;82(5):186-230
pubmed: 33421447
Clin Microbiol Infect. 2021 Apr;27(4):636.e1-636.e4
pubmed: 33421573
J Clin Microbiol. 2020 Dec 17;59(1):
pubmed: 33023911
EClinicalMedicine. 2021 Jan;31:100677
pubmed: 33521610
Emerg Microbes Infect. 2020 Dec;9(1):747-756
pubmed: 32196430