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Abstract

Introduction

Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.

Aim

We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.

Methods

We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system.

Results

The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30.

Conclusions

This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

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A corrected article has been published for this content:
Author's correction for Euro Surveill. 2021;26(44)
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2021-11-04
2024-11-24
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2021.26.44.2100441
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References

  1. Wagenhäuser I, Knies K, Rauschenberger V, Eisenmann M, McDonogh M, Petri N, et al. Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR. EBioMedicine. 2021;69:103455.  https://doi.org/10.1016/j.ebiom.2021.103455  PMID: 34186490 
  2. Brümmer LE, Katzenschlager S, Gaeddert M, Erdmann C, Schmitz S, Bota M, et al. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis. PLoS Med. 2021;18(8):e1003735.  https://doi.org/10.1371/journal.pmed.1003735  PMID: 34383750 
  3. European Commission. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Luxembourg: Publications Office of the European Union; 1998. 7.12.98:L331/1EN. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079&from=DE
  4. Mbunkah HA, Reinhardt J, Kafere C, Scheiblauer H, Prat I, Nübling CM. In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme. Vox Sang. 2021;116(1):3-12.  https://doi.org/10.1111/vox.12996  PMID: 32986873 
  5. European Commission. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Luxembourg: Publications Office of the European Union; 2017. 5.5.2017:L 117/176. Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj
  6. Paul-Ehrlich-Institut (PEI). Minimum criteria for rapid SARS-CoV-2 antigen tests pursuant to section 1 para 1 sentence 1 TestVO (statutory test regulation): rapid antigen tests. Langen: PEI [Accessed: 28.10.2021]; Available from: https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/dossiers/minimum-criteria-for-rapid-sars-cov2-antigen-tests-01-12-2020.pdf?__blob=publicationFile&v=5
  7. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2. [Antigen tests for the direct detection of the coronavirus SARS-CoV-2. Bonn: BfArM. [Accessed: 28 Oct.2021]. German. Available from: https://antigentest.bfarm.de/ords/f?p=110:100:5215254674935:::::&tz=2:00
  8. Paul-Ehrlich-Institut (PEI). Comparative evaluation of the sensitivity of SARS-CoV-2 antigen rapid tests. Langen: PEI; 2021. Available from: https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/dossiers/evaluation-sars-cov2-antigen-tests-overview-04-12-2020.pdf?__blob=publicationFile&v=42
  9. Puyskens A, Krause E, Michel J, Nübling M, Scheiblauer H, Bourquain D, et al. Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Euro Surveill. 2021;26(44):2100442.
  10. INSTAND. Quantitative Bezugsproben zur Verbesserung der Vergleichbarkeit und Bewertung von Laborergebnissen zum Virusgenom-Nachweis von SARS-CoV-2. [Quantitative reference samples to improve comparability and evaluation of laboratory results for the detection of the SARS-CoV-2 viral genome]. Berlin: INSTAND; 2021. German. Available from: https://www.instand-ev.de/fileadmin/uploads/user_upload/Dokumente/Virologie/20210118g_Begleitheft_-_quantitative_Bezugsproben_1_und_2_-_SARS-CoV-2.pdf
  11. Michel J, Neumann M, Krause E, Rinner T, Muzeniek T, Grossegesse M, et al. Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Virol J. 2021;18(1):110.  https://doi.org/10.1186/s12985-021-01559-3  PMID: 34078394 
  12. Wölfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Müller MA, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020;581(7809):465-9.  https://doi.org/10.1038/s41586-020-2196-x  PMID: 32235945 
  13. Kim M-C, Cui C, Shin K-R, Bae J-Y, Kweon O-J, Lee M-K, et al. Duration of culturable SARS-CoV-2 in hospitalized patients with Covid-19. N Engl J Med. 2021;384(7):671-3.  https://doi.org/10.1056/NEJMc2027040  PMID: 33503337 
  14. Medical Device Coordination Group. Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. MDCG 2021-21. Brussels: European Union; 2021. Available from: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf
  15. World Health Organization (WHO). Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays: interim guidance, 11 September 2020. Geneva: WHO; 2020. Available from: https://apps.who.int/iris/handle/10665/334253
  16. United States Food and Drug Administration (FDA). In vitro diagnostics EUAs. Silver Spring: FDA. [Accessed: 28 Oct 2021]. Available from: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#individual-antigen
  17. European Centre for Disease Prevention and Control (ECDC). Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK. Stockholm: ECDC; 2020. Technical report. Available from: https://www.ecdc.europa.eu/sites/default/files/documents/Options-use-of-rapid-antigen-tests-for-COVID19-19-11-2020.pdf
  18. Schweizerischer Bundesrat. Verordnung 3 über Massnahmen zur Bekämpfung des Coronavirus (Covid-19) (Covid-19-Verordnung 3). SR 818.101.24. Anhang 5a. [Ordinance 3 on measures to combat the coronavirus (COVID-19) (COVID-19 Ordinance 3). SR 818.101.24. Annex 5a]. Bern: Schweizerischer Bundesrat; 2020. German. Available from: https://www.fedlex.admin.ch/eli/cc/2020/438/de#annex_5_a
  19. Foundation for Innovative New Diagnostics (FIND). FIND evaluation of SARS-CoV-2 antigen (Ag) detecting tests. Geneva: FIND. [Accessed: 28 Oct 2021]. Available from: https://www.finddx.org/sarscov2-eval-antigen
  20. Corman VM, Haage VC, Bleicker T, Schmidt ML, Mühlemann B, Zuchowski M, et al. Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe. 2021;2(7):e311-9.  https://doi.org/10.1016/S2666-5247(21)00056-2  PMID: 33846704 
  21. World Health Organization (WHO). Collaborative study for the establishment of a WHO international standard for SARS-CoV-2 RNA. WHO/BS/2020.2402. Geneva: WHO; 2020. Available from: https://www.who.int/publications/m/item/WHO-BS-2020.2402
  22. Krüger LJ, Gaeddert M, Köppel L, Brümmer LE, Gottschalk C, Miranda IB, et al. Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2. Preprint. MedRxiv. 2020.10.01.20203836. https://doi.org/ https://doi.org/10.1101/2020.10.01.20203836 
  23. Young S, Taylor SN, Cammarata CL, Roger-Dalbert C, Montano A, Griego-Fullbright C, et al. Clinical evaluation of BD VeritorTM SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS antigen point-of-care test. Preprint. MedRxiv. 2020.09.01.20185777. https://doi.org/ https://doi.org/10.1101/2020.09.01.20185777 
  24. Weitzel T, Legarraga P, Iruretagoyena M, Pizarro G, Vollrath V, Arao R, et al. Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of 1 SARS-CoV-2 in respiratory samples. Preprint. BioRxiv. 2020.05.27.119255. https://doi.org/ https://doi.org/10.1101/2020.05.27.119255 
  25. Berger A, Ngo Nsoga MT, Perez-Rodriguez JF, Aad YA, Sattonnet-Roche P, Gayet-Ageron A, et al. Diagnostic accuracy of two commercial SARS-CoV-2 Antigen-detecting 1 rapid tests at the point of care in community-based testing centers. Preprint. MedRxiv. 2020.11.20.20235341. https://doi.org/ https://doi.org/10.1101/2020.11.20.20235341 
  26. Bundesamt für Gesundheit (BAG). Fachinformationen über die Covid-19-Testung. [Technical information about Covid-19 testing]. Bern: BAG. [Accessed: 28 Oct 2021]. German. Available from: https://www.bag.admin.ch/bag/de/home/krankheiten/ausbrueche-epidemien-pandemien/aktuelle-ausbrueche-epidemien/novel-cov/information-fuer-die-aerzteschaft/covid-testung.html
  27. Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, et al. , Cochrane COVID-19 Diagnostic Test Accuracy Group. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020;8(8):CD013705.  https://doi.org/10.1002/14651858.CD013705  PMID: 32845525 
  28. Mak GCK, Lau SSY, Wong KKY, Chow NLS, Lau CS, Lam ETK, et al. Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus. J Clin Virol. 2020;133:104684.  https://doi.org/10.1016/j.jcv.2020.104684  PMID: 33176236 
Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Heinrich+Scheiblauer&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Scheiblauer Heinrich</a>, <a href="/search?value1=Angela+Filomena&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Filomena Angela</a>, <a href="/search?value1=Andreas+Nitsche&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Nitsche Andreas</a>, <a href="/search?value1=Andreas+Puyskens&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Puyskens Andreas</a>, <a href="/search?value1=Victor+M+Corman&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Corman Victor M</a>, <a href="/search?value1=Christian+Drosten&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Drosten Christian</a>, <a href="/search?value1=Karin+Zwirglmaier&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Zwirglmaier Karin</a>, <a href="/search?value1=Constanze+Lange&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Lange Constanze</a>, <a href="/search?value1=Petra+Emmerich&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Emmerich Petra</a>, <a href="/search?value1=Michael+M%C3%BCller&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Müller Michael</a>, <a href="/search?value1=Olivia+Knauer&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Knauer Olivia</a>, <a href="/search?value1=C+Micha+N%C3%BCbling&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Nübling C Micha</a></span>. Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. <a href="/content/ecdc">Euro Surveill.</a> 2021;26(44):pii=2100441. <a href="https://doi.org/10.2807/1560-7917.ES.2021.26.44.2100441" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2021.26.44.2100441</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 07 May 2021;&nbsp;&nbsp; <span class="generated">Accepted</span>: 14 Oct 2021 </span> </p>
/content/10.2807/1560-7917.ES.2021.26.44.2100441
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