1887

Access Microbiology open research platform logo

Volume 4, Issue 6

Performance study of the anterior nasal AMP SARS-CoV-2 rapid antigen test in comparison with nasopharyngeal rRT-PCR Open Access

Abstract

The gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection is real-time reverse transcription PCR (rRT-PCR), which is expensive, has a long turnaround time and requires special equipment and trained personnel. Nasopharyngeal swabs are uncomfortable, not suitable for certain patient groups and do not allow self-testing. Convenient, well-tolerated rapid antigen tests (RATs) for SARS-CoV-2 detection are called for.

More real-life performance data on anterior nasal RATs are required.

We set out to evaluate the anterior nasal AMP RAT in comparison with rRT-PCR in a hospital cohort.

The study included 175 patients, either hospitalized in a coronavirus disease 2019 (COVID-19) ward or screened in a preadmittance outpatient clinic. Two swabs were collected per patient: an anterior nasal one for the RAT and a combined naso-/oropharyngeal one for the rRT-PCR. Sixty-five patients (37%) were rRT-PCR-positive [cycle threshold ( ) <40].

The anterior nasal AMP RAT showed an overall sensitivity and specificity of 29.2 % (18.6–41.8, 95 % CI) and 100.0 % (96.7–100.0, 95 % CI) respectively. In patients with a value <25, <30 and <33, higher sensitivities were observed. Time since symptom onset was significantly higher in patients with a false-negative RAT (=0.02).

The anterior nasal AMP RAT showed low sensitivities in this cohort, especially in patients with a longer time since symptom onset. Further knowledge concerning the viral load and antigen expression over time and in different swabbing locations is needed to outline the usage time frame for SARS-CoV-2 RAT.

  • Received:
  • Accepted:
  • Published Online:
Keyword(s): anterior nasal testing , antigen expression , coronavirus , COVID-19 , RT-PCR and viral load
© 2022 The Authors
  • This is an open-access article distributed under the terms of the Creative Commons Attribution License.
Loading

Article metrics loading...

/content/journal/acmi/10.1099/acmi.0.000361
2022-06-01
2024-04-23
Loading full text...

Full text loading...

/deliver/fulltext/acmi/4/6/acmi000361.html?itemId=/content/journal/acmi/10.1099/acmi.0.000361&mimeType=html&fmt=ahah

References

  1. CDC Overview of Testing for SARS-CoV-2 (COVID-19); 2020 https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html accessed 21 October 2020
  2. ECDC Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK; 2020 https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-and-uk accessed 19 November 2020
  3. WHO Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases; 2020 https://www.who.int/publications/i/item/10665-331501 accessed 19 March 2020
  4. CDC Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing; 2021 https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html accessed 26 February 2021
  5. Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill 2020; 25:pii=2000045 [View Article] [PubMed]
     [Google Scholar]
  6. Pai NP, Vadnais C, Denkinger C, Engel N, Pai M. Point-of-care testing for infectious diseases: diversity, complexity, and barriers in low- and middle-income countries. PLoS Med 2012; 9:e1001306 [View Article] [PubMed]
     [Google Scholar]
  7. Clerc O, Greub G. Routine use of point-of-care tests: usefulness and application in clinical microbiology. Clin Microbiol Infect 2010; 16:1054–1061 [View Article] [PubMed]
     [Google Scholar]
  8. Lai CC, Wang CY, Ko WC, Hsueh PR. In vitro diagnostics of coronavirus disease 2019: Technologies and application. J Microbiol Immunol Infect 2021; 54:164–174 [View Article] [PubMed]
     [Google Scholar]
  9. Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem 2016; 60:111–120 [View Article] [PubMed]
     [Google Scholar]
  10. WHO Considerations for implementing and adjusting public health and social measures in the context of COVID-19; 2021 https://www.who.int/publications/i/item/considerations-in-adjusting-public-health-and-social-measures-in-the-context-of-covid-19-interim-guidance accessed 14 June 2021
  11. WHO Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays; 2020 https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
  12. FIND COVID-19 Diagnostics & Testing; 2021 https://www.finddx.org/covid-19/
  13. Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev 2021; 3:CD013705 [View Article] [PubMed]
     [Google Scholar]
  14. FDA In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2; 2021 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 accessed 16 June 2021
  15. Leixner G, Voill-Glaninger A, Bonner E, Kreil A, Zadnikar R et al. Evaluation of the AMP SARS-CoV-2 rapid antigen test in a hospital setting. Int J Infect Dis 2021; 108:353–356 [View Article] [PubMed]
     [Google Scholar]
  16. AMP Diagnostics AMP Rapid Test SARS-CoV-2 Ag; 2020 https://www.amp-med.com/news-rapid-test-sars-cov-2-ag
  17. WHO Coronavirus, Symptoms; 2021 https://www.who.int/health-topics/coronavirus#tab=tab_3
  18. Bundesministerium Soziales Gesundheit Pflege und Konsumentenschutz Empfehlung Für die Gesundheitsbehörden zur Entlassung von COVID-19-Fällen aus der Absonderung; 2021 https://www.aekktn.at/documents/3b4d12c9-620b-11eb-8af6-52540052f55b accessed 27 January 2021
  19. Robert Koch Institut COVID-19: Entlassungskriterien aus der Isolierung; 2021 https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Entlassmanagement accessed 2 February 2021
  20. Homza M, Zelena H, Janosek J, Tomaskova H, Jezo E et al. Performance of seven SARS-CoV-2 Self-tests based on saliva, anterior nasal and nasopharyngeal swabs corrected for infectiousness in real-life conditions: a cross-sectional test accuracy study. Diagnostics (Basel) 2021; 11:1567 [View Article] [PubMed]
     [Google Scholar]
  21. Klein JAF, Krüger LJ, Tobian F, Gaeddert M, Lainati F et al. Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test. Med Microbiol Immunol 2021; 210:181–186 [View Article] [PubMed]
     [Google Scholar]
  22. Lindner AK, Nikolai O, Kausch F, Wintel M, Hommes F et al. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab versus professional-collected nasopharyngeal swab. Eur Respir J 2021; 57:2003961 [View Article] [PubMed]
     [Google Scholar]
  23. Lindner AK, Nikolai O, Rohardt C, Burock S, Hülso C et al. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with professional-collected nasal versus nasopharyngeal swab. Eur Respir J 2021; 57:2004430 [View Article] [PubMed]
     [Google Scholar]
  24. Péré H, Podglajen I, Wack M, Flamarion E, Mirault T et al. Nasal swab sampling for SARS-CoV-2: a Convenient alternative in times of nasopharyngeal swab shortage. J Clin Microbiol 2020; 58:e00721-20 [View Article] [PubMed]
     [Google Scholar]
  25. Krüttgen A, Cornelissen CG, Dreher M, Hornef MW, Imöhl M et al. Comparison of the SARS-CoV-2 Rapid antigen test to the real star SARS-CoV-2 RT PCR kit. J Virol Methods 2021; 288:114024 [View Article] [PubMed]
     [Google Scholar]
  26. Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS et al. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol 2020; 129:104500 [View Article] [PubMed]
     [Google Scholar]
  27. Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis 2020; 99:328–333 [View Article] [PubMed]
     [Google Scholar]
  28. Scohy A, Anantharajah A, Bodéus M, Kabamba-Mukadi B, Verroken A et al. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol 2020; 129:104455 [View Article] [PubMed]
     [Google Scholar]
  29. Brümmer LE, Katzenschlager S, Gaeddert M, Erdmann C, Schmitz S et al. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis. PLoS Med 2021; 18:e1003735 [View Article] [PubMed]
     [Google Scholar]
  30. Clark JH, Pang S, Naclerio RM, Kashima M. Complications of nasal SARS-CoV-2 testing: a review. J Investig Med 2021; 69:1399–1403 [View Article] [PubMed]
     [Google Scholar]
  31. Fabbris C, Cestaro W, Menegaldo A, Spinato G, Frezza D et al. Is oro/nasopharyngeal swab for SARS-CoV-2 detection a safe procedure? Complications observed among a case series of 4876 consecutive swabs. Am J Otolaryngol 2021; 42:102758 [View Article] [PubMed]
     [Google Scholar]
  32. Gupta K, Bellino PM, Charness ME. Adverse effects of nasopharyngeal swabs: Three-dimensional printed versus commercial swabs. Infect Control Hosp Epidemiol 2021; 42:641–642 [View Article] [PubMed]
     [Google Scholar]
http://instance.metastore.ingenta.com/content/journal/acmi/10.1099/acmi.0.000361
Loading
Performance study of the anterior nasal AMP SARS-CoV-2 rapid antigen test in comparison with nasopharyngeal rRT-PCR
Access Microbiology 4, 000361 (2022); https://doi.org/10.1099/acmi.0.000361
/content/journal/acmi/10.1099/acmi.0.000361
/content/journal/acmi/10.1099/acmi.0.000361
Loading

Data & Media loading...

Supplements

Supplementary material 1

PDF

Most cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error