Factors that Influence the Reported Sensitivity of Rapid Antigen Testing for SARS-CoV-2.

RT-PCR SARS-CoV-2 diagnostic accuracy meta-regression analysis rapid antigen testing systematic review and meta-analysis test sensitivity viral culture

Journal

Frontiers in microbiology
ISSN: 1664-302X
Titre abrégé: Front Microbiol
Pays: Switzerland
ID NLM: 101548977

Informations de publication

Date de publication:
2021
Historique:
received: 24 05 2021
accepted: 18 08 2021
entrez: 22 10 2021
pubmed: 23 10 2021
medline: 23 10 2021
Statut: epublish

Résumé

Tests that detect the presence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antigen in clinical specimens from the upper respiratory tract can provide a rapid means of coronavirus disease 2019 (COVID-19) diagnosis and help identify individuals who may be infectious and should isolate to prevent SARS-CoV-2 transmission. This systematic review assesses the diagnostic accuracy of SARS-CoV-2 antigen detection in COVID-19 symptomatic and asymptomatic individuals compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) and summarizes antigen test sensitivity using meta-regression. In total, 83 studies were included that compared SARS-CoV-2 rapid antigen-based lateral flow testing (RALFT) to RT-qPCR for SARS-CoV-2. Generally, the quality of the evaluated studies was inconsistent; nevertheless, the overall sensitivity for RALFT was determined to be 75.0% (95% confidence interval: 71.0-78.0). Additionally, RALFT sensitivity was found to be higher for symptomatic vs. asymptomatic individuals and was higher for a symptomatic population within 7 days from symptom onset compared to a population with extended days of symptoms. Viral load was found to be the most important factor for determining SARS-CoV-2 antigen test sensitivity. Other design factors, such as specimen storage and anatomical collection type, also affect the performance of RALFT. RALFT and RT-qPCR testing both achieve high sensitivity when compared to SARS-CoV-2 viral culture.

Identifiants

pubmed: 34675892
doi: 10.3389/fmicb.2021.714242
pmc: PMC8524138
doi:

Types de publication

Journal Article

Langues

eng

Pagination

714242

Informations de copyright

Copyright © 2021 Parvu, Gary, Mann, Lin, Mills, Cooper, Andrews, Manabe, Pekosz and Cooper.

Déclaration de conflit d'intérêts

VP, DG, Y-CL, DM, LC, JM, JA, and CC are employees of Becton, Dickinson and Company. The remaining 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

J Infect Chemother. 2021 Apr;27(4):613-616
pubmed: 33423918
Clin Microbiol Infect. 2021 Mar;27(3):487-488
pubmed: 32979567
Eur J Epidemiol. 2021 Feb;36(2):179-196
pubmed: 33634345
Expert Rev Anti Infect Ther. 2010 May;8(5):517-27
pubmed: 20455681
AJR Am J Roentgenol. 2006 Aug;187(2):271-81
pubmed: 16861527
J Infect Chemother. 2021 Feb;27(2):384-386
pubmed: 33397587
Clin Microbiol Infect. 2014 Feb;20(2):105-13
pubmed: 24274632
J Pediatr. 2021 May;232:287-289.e4
pubmed: 33484697
J Infect. 2021 Mar;82(3):e14-e16
pubmed: 33347944
N Engl J Med. 2020 Mar 26;382(13):1199-1207
pubmed: 31995857
J Med Virol. 2021 May;93(5):3152-3157
pubmed: 33615487
Clin Microbiol Infect. 2021 Feb;27(2):289.e1-289.e4
pubmed: 33031947
Travel Med Infect Dis. 2021 Jan-Feb;39:101942
pubmed: 33278609
Nat Commun. 2021 Jan 11;12(1):267
pubmed: 33431879
MMWR Morb Mortal Wkly Rep. 2021 Jan 22;70(3):100-105
pubmed: 33476316
J Clin Microbiol. 2021 Mar 19;59(4):
pubmed: 33441395
Evid Based Ment Health. 2019 Nov;22(4):153-160
pubmed: 31563865
JAMA. 2020 Mar 17;323(11):1061-1069
pubmed: 32031570
J Clin Microbiol. 2021 Apr 20;59(5):
pubmed: 33622768
Reprod Biomed Online. 2020 Sep;41(3):483-499
pubmed: 32651106
J Clin Virol. 2020 Nov;132:104654
pubmed: 33053494
J Clin Virol. 2021 Feb;135:104713
pubmed: 33352470
EClinicalMedicine. 2021 Jun;36:100924
pubmed: 34101770
PLoS One. 2023 Feb 24;18(2):e0282150
pubmed: 36827328
J Infect Dis. 2021 Apr 8;223(7):1139-1144
pubmed: 33394052
Med Microbiol Immunol. 2021 Feb;210(1):65-72
pubmed: 33452927
Int J Infect Dis. 2021 Mar;104:65-72
pubmed: 33401037
Expert Rev Mol Diagn. 2020 May;20(5):453-454
pubmed: 32297805
JAMA. 2020 Mar 17;323(11):1092-1093
pubmed: 32031568
Lancet. 2011 Jan 8;377(9760):108-9
pubmed: 20630580
Ann Intern Med. 2020 Sep 1;173(5):362-367
pubmed: 32491919
Clin Infect Dis. 2021 Nov 2;73(9):e3098-e3101
pubmed: 33367619
Clin Infect Dis. 2021 Apr 8;72(7):1253-1255
pubmed: 32596725
Clin Chem Lab Med. 2021 Apr 07;59(8):1468-1476
pubmed: 33823089
J Clin Med. 2021 Jan 17;10(2):
pubmed: 33477365
Microorganisms. 2020 Dec 28;9(1):
pubmed: 33379279
Epidemiol Mikrobiol Imunol. 2021 Summer;70(3):156-160
pubmed: 34641689
J Virol Methods. 2021 Feb;288:114024
pubmed: 33227341
Syst Rev. 2021 Mar 29;10(1):89
pubmed: 33781348
Nature. 2020 May;581(7809):465-469
pubmed: 32235945
Biomolecules. 2021 Mar 13;11(3):
pubmed: 33805832
PLoS Med. 2021 Aug 12;18(8):e1003735
pubmed: 34383750
Dan Med J. 2021 Jun 14;68(7):
pubmed: 34169830
PLoS One. 2021 Jun 24;16(6):e0253321
pubmed: 34166410
MMWR Morb Mortal Wkly Rep. 2021 Jan 01;69(5152):1642-1647
pubmed: 33382679
PLoS One. 2021 Mar 31;16(3):e0248921
pubmed: 33788882
J Infect Chemother. 2021 Feb;27(2):406-409
pubmed: 33183963
Nat Commun. 2020 Nov 12;11(1):5749
pubmed: 33184277
J Clin Microbiol. 2020 Sep 22;58(10):
pubmed: 32665419
J Clin Virol. 2020 Dec;133:104659
pubmed: 33160179
Clin Microbiol Infect. 2021 Mar;27(3):472.e7-472.e10
pubmed: 33189872
J Clin Virol. 2021 Jan;134:104712
pubmed: 33338894
Euro Surveill. 2020 May;25(21):
pubmed: 32489176
Infect Control Hosp Epidemiol. 2022 Jan;43(1):99-101
pubmed: 33487197
J Infect Chemother. 2021 Feb;27(2):319-322
pubmed: 33388232
Infect Dis Ther. 2021 Jun;10(2):753-761
pubmed: 33629225
J Clin Virol. 2021 Apr;137:104785
pubmed: 33711694
J Med Virol. 2021 May;93(5):2988-2991
pubmed: 33527409
Clin Infect Dis. 2021 Nov 2;73(9):e2861-e2866
pubmed: 33479756
J Infect Chemother. 2021 Jun;27(6):890-894
pubmed: 33727026
J Clin Microbiol. 2021 Jan 21;59(2):
pubmed: 33139420
J Infect Dis. 2021 Sep 17;224(6):976-982
pubmed: 34191025
Eur Respir J. 2021 Apr 15;57(4):
pubmed: 33303544
Int J Infect Dis. 2020 Oct;99:397-402
pubmed: 32800855
Biomarkers. 2021 May;26(3):213-220
pubmed: 33455451
Cochrane Database Syst Rev. 2020 Aug 26;8:CD013705
pubmed: 32845525
J Clin Virol. 2020 Aug;129:104455
pubmed: 32485618
J Infect. 2021 May;82(5):186-230
pubmed: 33421447
N Engl J Med. 2020 Nov 26;383(22):e120
pubmed: 32997903
JAMA. 1999 Sep 15;282(11):1061-6
pubmed: 10493205
J Clin Med. 2021 Jan 13;10(2):
pubmed: 33450853
Diagnostics (Basel). 2020 Dec 23;11(1):
pubmed: 33374612
J Infect. 2020 Sep;81(3):357-371
pubmed: 32615199
Am J Respir Crit Care Med. 2020 Feb 15;201(4):P7-P8
pubmed: 32004066
Nat Med. 2020 May;26(5):672-675
pubmed: 32296168
Anal Bioanal Chem. 2021 Jan;413(1):35-48
pubmed: 32944809
J Med Virol. 2021 Apr;93(4):1920-1922
pubmed: 33406271
Mol Immunol. 2021 Mar;131:6-12
pubmed: 33450670
J Hosp Infect. 2021 Apr;110:203-205
pubmed: 33539935
Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1059-1061
pubmed: 32342252
J Clin Virol. 2020 Dec;133:104684
pubmed: 33176236
Clin Microbiol Infect. 2021 Apr;27(4):636.e1-636.e4
pubmed: 33421573
Int J Infect Dis. 2021 Mar;104:282-286
pubmed: 33130198
Int J Mol Sci. 2020 Apr 24;21(8):
pubmed: 32344568
J Clin Microbiol. 2020 Dec 17;59(1):
pubmed: 33023911
J Clin Microbiol. 2021 Mar 19;59(4):
pubmed: 33509809
Virol J. 2020 Nov 13;17(1):177
pubmed: 33187528
J Clin Microbiol. 2021 Jan 21;59(2):
pubmed: 33239376
Explor Res Clin Soc Pharm. 2021 Sep;3:100047
pubmed: 34568868
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32404480
Eur J Clin Microbiol Infect Dis. 2021 Aug;40(8):1721-1726
pubmed: 33742322
ACS Cent Sci. 2020 May 27;6(5):591-605
pubmed: 32382657
PLoS One. 2021 Sep 7;16(9):e0253407
pubmed: 34492025
Clin Microbiol Infect. 2021 Feb 16;:
pubmed: 33601009
medRxiv. 2020 Nov 05;:
pubmed: 32577700
EClinicalMedicine. 2021 Jan;31:100677
pubmed: 33521610
Int J Infect Dis. 2020 Oct;99:328-333
pubmed: 32497809
Clin Infect Dis. 2021 May 18;72(10):e685-e686
pubmed: 32785682
Clin Infect Dis. 2021 Nov 2;73(9):e2908-e2917
pubmed: 32945845
Sci Adv. 2021 Jan 1;7(1):
pubmed: 33219112
Open Forum Infect Dis. 2021 Feb 02;8(3):ofab059
pubmed: 33723512
Lab Med. 2021 Mar 15;52(2):e46-e49
pubmed: 33283230
Lancet Infect Dis. 2021 Sep;21(9):e290-e295
pubmed: 33636148

Auteurs

Valentin Parvu (V)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Devin S Gary (DS)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Joseph Mann (J)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Yu-Chih Lin (YC)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Dorsey Mills (D)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Lauren Cooper (L)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Jeffrey C Andrews (JC)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Yukari C Manabe (YC)

W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.

Andrew Pekosz (A)

W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.

Charles K Cooper (CK)

Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.

Classifications MeSH