Skip to main content
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems
  • Log in
  • My alerts
  • My Cart

Main menu

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About JCM
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems

User menu

  • Log in
  • My alerts
  • My Cart

Search

  • Advanced search
Journal of Clinical Microbiology
publisher-logosite-logo

Advanced Search

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About JCM
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
Letter to the Editor

Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19

Florence Fenollar, Amar Bouam, Mehdi Ballouche, Léa Fuster, Elsa Prudent, Philippe Colson, Hervé Tissot-Dupont, Matthieu Million, Michel Drancourt, Didier Raoult, Pierre-Edouard Fournier
Angela M. Caliendo, Editor
Florence Fenollar
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
bUMR MEPHI, Aix-Marseille Université, IRD, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Florence Fenollar
Amar Bouam
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mehdi Ballouche
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Léa Fuster
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
cUMR VITROME, Aix-Marseille Université, IRD, Service de Santé des Armées, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Elsa Prudent
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Philippe Colson
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
bUMR MEPHI, Aix-Marseille Université, IRD, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Hervé Tissot-Dupont
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
bUMR MEPHI, Aix-Marseille Université, IRD, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Matthieu Million
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
bUMR MEPHI, Aix-Marseille Université, IRD, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michel Drancourt
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
bUMR MEPHI, Aix-Marseille Université, IRD, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Michel Drancourt
Didier Raoult
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
bUMR MEPHI, Aix-Marseille Université, IRD, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Didier Raoult
Pierre-Edouard Fournier
aInstitut Hospitalo-universitaire Méditerranée Infection, Marseille, France
cUMR VITROME, Aix-Marseille Université, IRD, Service de Santé des Armées, Assistance Publique-Hôpitaux de Marseille, Institut Hospitalo-Universitaire Méditerranée-Infection, Marseille, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Pierre-Edouard Fournier
Angela M. Caliendo
Rhode Island Hospital
Roles: Editor
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
DOI: 10.1128/JCM.02589-20
  • Article
  • Figures & Data
  • Info & Metrics
  • PDF
Loading

LETTER

Coronavirus disease 2019 (COVID-19), declared a pandemic by the WHO on 11 March 2020 (1), requires an early diagnosis to optimize patient management and limit further transmission. Currently, the gold standard and most commonly used diagnostic method in clinical microbiology laboratories is real-time PCR (RT-PCR) detecting the viral RNA in nasopharyngeal specimens (2). However, RT-PCR requires specialized instruments and personnel. In contrast, rapid antigen (Ag) detection (RAD) tests, which are widely used to diagnose viral diseases other than COVID-19, not only are rapid (15 to 30 min) but are less laborious and require only a comparatively short training period. However, to date, several commercialized RAD tests have been evaluated and most have demonstrated a lack of sensitivity (see Table S1 in the supplemental material).

In the present study, we evaluated the performance of the Panbio COVID-19 Ag rapid test device assay (Abbott) in comparison to that of the VitaPCR severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay (Credo Diagnostics, Singapore) on nasopharyngeal specimens. Both systems provide results within 20 min. The former is an immunochromatographic assay detecting the SARS-CoV-2 nucleocapsid protein and requiring no specialized instruments. This device is distributed worldwide except in the United States, where its equivalent, the BinaxNOW COVID-19 Ag card (Abbott), is FDA approved. Using 10-fold dilutions of a quantified suspension of Vero E6 cell-cultured SARS-CoV-2 (IHUMI3 strain), as previously described (3), from 780 × 106 copies/ml at a dilution of 10−1 to 1,484 copies/ml at a dilution of 10−6, we found that the RT-PCR assay was positive for all tested virus dilutions, with cycle threshold (CT) values of 16 and 34 for the most concentrated (10−1) and most dilute (10−6) solutions, respectively. In contrast, the RAD test was positive for all dilutions except 10−5 and 10−6. Two further replicates of this evaluation confirmed these results for both assays. Then, we tested prospectively, from 21 September to 2 October 2020, nasopharyngeal samples from 341 patients and subjects who presented at our institute for COVID-19 testing using the two methods. Of these, 182 were symptomatic patients and 159 were asymptomatic subjects who had had contact with patients. For each patient, two nasopharyngeal samples were collected, from one nostril each, with a specific swab according to the assay used. All tests were performed within 1 h after specimen collection. All of the 182 symptomatic patients but only 22 of the 159 asymptomatic patients were PCR positive (median CT values, 25 and 30.5, respectively, P < 10−2, Table 1), for a total of 204 PCR positives (Table S2). The Panbio COVID-19 Ag rapid test detected 154 of the 204 PCR-positive samples (sensitivity, 75.5%; 95% confidence interval [95% CI], 69.5 to 81.5), including 144/182 symptomatic patients (79.1%), but only 10/22 asymptomatic patients (45.4%). However, the test result was positive in 7 of the 137 PCR-negative samples, all of which had been collected from asymptomatic patients (specificity, 94.9%; 95% CI, 91.2 to 98.6). Among the individuals diagnosed (n = 204) or not diagnosed (n = 137) with COVID-19, positive and negative predictive values were 95.6% (154/161) and 72.2% (130/180), respectively.

View this table:
  • View inline
  • View popup
  • Download powerpoint
TABLE 1

Sensitivity of the Panbio COVID-19 Ag rapid test (Abbott) according to the CT values

We acknowledge the fact that our study population may not be representative of the general population of Marseille as symptomatic patients also came from other cities from southern France and were thus overrepresented. However, our study showed that the Panbio COVID-19 Ag rapid test had a good specificity for SARS-CoV-2 detection in nasopharynx swab samples but a good sensitivity only for samples with CT values lower than 25 (corresponding to viral loads higher than 106 copies/ml, which has been proposed as threshold of transmissibility [4, 5]). In our study, all 10 asymptomatic patients, as well as 57/144 symptomatic patients, exhibited CT values of ≥25 (Table S2). In this population, the Panbio COVID-19 Ag rapid test may miss about 40% of diagnoses. However, as the clinical performance of RAD tests largely depends on the setting in which they are used, we believe that the Panbio COVID-19 Ag rapid test may be a useful mass screening test when RT-PCR assays are not or are insufficiently available, in particular, in symptomatic patients.

The patients gave informed consent for this study.

ACKNOWLEDGMENTS

This study was supported by the Méditerranée-Infection Foundation and the French Agence Nationale de la Recherche under reference Investissements d’Avenir Méditerranée Infection 10-IAHU-03 and Région Provence-Alpes-Côte d’Azur and European funding FEDER IHUBIOTK.

D.R. and M.D. are cofounders of the Pocrame startup, which develops diagnostic devices for infectious diseases. We certify that we have no other conflict of interest to declare in relation to this research.

Our contributions were as follows: conceptualization, D.R. and P.-E.F.; formal analysis, F.F., D.R., and P.-E.F.; investigation, A.B., M.B., L.F., E.P., H.T.-D., and M.M.; resources, D.R. and P.-E.F.; data curation, P.C.; writing—original draft preparation, F.F. and P.-E.F.; writing—review and editing, F.F., M.D., D.R., and P.-E.F. All of us have read and agreed to the published version of the manuscript.

FOOTNOTES

    • Accepted manuscript posted online 2 November 2020.
  • Supplemental material is available online only.

  • Copyright © 2021 American Society for Microbiology.

All Rights Reserved.

This article is made available via the PMC Open Access Subset for unrestricted noncommercial re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

REFERENCES

  1. 1.↵
    WHO. 11 March 2020. Coronavirus disease (COVID-19) situation report – 51. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200311-sitrep-51-covid-19.pdf?sfvrsn=1ba62e57810.
  2. 2.↵
    1. Corman VM,
    2. Landt O,
    3. Kaiser M,
    4. Molenkamp R,
    5. Meijer A,
    6. Chu DK,
    7. Bleicker T,
    8. Brunink S,
    9. Schneider J,
    10. Schmidt ML,
    11. Mulders DG,
    12. Haagmans BL,
    13. van der Veer B,
    14. van den Brink S,
    15. Wijsman L,
    16. Goderski G,
    17. Romette JL,
    18. Ellis J,
    19. Zambon M,
    20. Peiris M,
    21. Goossens H,
    22. Reusken C,
    23. Koopmans MP,
    24. Drosten C
    . 2020. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. EuroSurveill 25(3): pii=2000045. https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.3.2000045.
    OpenUrl
  3. 3.↵
    1. La Scola B,
    2. Le Bideau M,
    3. Andreani J,
    4. Hoang VT,
    5. Grimaldier C,
    6. Colson P,
    7. Gautret P,
    8. Raoult D
    . 2020. Viral DNA as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards. Eur J Clin Microbiol Infect Dis 39:1059–1061. doi:10.1007/s10096-020-03913-9.
    OpenUrlCrossRefPubMed
  4. 4.↵
    1. He D,
    2. Zhao S,
    3. Lin Q,
    4. Zhuang Z,
    5. Cao P,
    6. Wang MH,
    7. Yang L
    . 2020. The relative transmissibility of asymptomatic COVID-19 infections among close contacts. Int J Infect Dis 94:145–147. doi:10.1016/j.ijid.2020.04.034.
    OpenUrlCrossRef
  5. 5.↵
    1. Wölfel R,
    2. Corman VM,
    3. Guggemos W,
    4. Seilmaier M,
    5. Zange S,
    6. Müller MA,
    7. Niemeyer D,
    8. Jones TC,
    9. Vollmar P,
    10. Rothe C,
    11. Hoelscher M,
    12. Bleicker T,
    13. Brünink S,
    14. Schneider J,
    15. Ehmann R,
    16. Zwirglmaier K,
    17. Drosten C,
    18. Wendtner C
    . 2020. Virological assessment of hospitalized patients with COVID-2019. Nature 581:465–469. doi:10.1038/s41586-020-2196-x.
    OpenUrlCrossRefPubMed
PreviousNext
Back to top
Download PDF
Citation Tools
Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19
Florence Fenollar, Amar Bouam, Mehdi Ballouche, Léa Fuster, Elsa Prudent, Philippe Colson, Hervé Tissot-Dupont, Matthieu Million, Michel Drancourt, Didier Raoult, Pierre-Edouard Fournier
Journal of Clinical Microbiology Jan 2021, 59 (2) e02589-20; DOI: 10.1128/JCM.02589-20

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Print

Alerts
Sign In to Email Alerts with your Email Address
Email

Thank you for sharing this Journal of Clinical Microbiology article.

NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. We do not retain these email addresses.

Enter multiple addresses on separate lines or separate them with commas.
Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19
(Your Name) has forwarded a page to you from Journal of Clinical Microbiology
(Your Name) thought you would be interested in this article in Journal of Clinical Microbiology.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Share
Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19
Florence Fenollar, Amar Bouam, Mehdi Ballouche, Léa Fuster, Elsa Prudent, Philippe Colson, Hervé Tissot-Dupont, Matthieu Million, Michel Drancourt, Didier Raoult, Pierre-Edouard Fournier
Journal of Clinical Microbiology Jan 2021, 59 (2) e02589-20; DOI: 10.1128/JCM.02589-20
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Top
  • Article
    • LETTER
    • ACKNOWLEDGMENTS
    • FOOTNOTES
    • REFERENCES
  • Figures & Data
  • Info & Metrics
  • PDF

KEYWORDS

COVID-19
SARS-CoV-2
diagnosis
antigen assay
rapid diagnosis
RT-PCR
rapid antigenic device
sensitivity

Related Articles

Cited By...

About

  • About JCM
  • Editor in Chief
  • Board of Editors
  • Editor Conflicts of Interest
  • For Reviewers
  • For the Media
  • For Librarians
  • For Advertisers
  • Alerts
  • RSS
  • FAQ
  • Permissions
  • Journal Announcements

Authors

  • ASM Author Center
  • Submit a Manuscript
  • Article Types
  • Resources for Clinical Microbiologists
  • Ethics
  • Contact Us

Follow #JClinMicro

@ASMicrobiology

       

ASM Journals

ASM journals are the most prominent publications in the field, delivering up-to-date and authoritative coverage of both basic and clinical microbiology.

About ASM | Contact Us | Press Room

 

ASM is a member of

Scientific Society Publisher Alliance

 

American Society for Microbiology
1752 N St. NW
Washington, DC 20036
Phone: (202) 737-3600

 

Copyright © 2021 American Society for Microbiology | Privacy Policy | Website feedback

Print ISSN: 0095-1137; Online ISSN: 1098-660X