1887
  1. Home
  2. Eurosurveillance
  3. Volume 28, Issue 38, 21/Sep/2023
  4. Article
Research Open Access
Like 0
Download

Abstract

Background

The sensitivity and specificity of selected antigen detection rapid diagnostic tests (AG-RDTs) for SARS-CoV-2 were determined in the unvaccinated population when the Delta variant was circulating. Viral loads, dynamics, symptoms and tissue tropism differ between Omicron and Delta.

Aim

We aimed to compare AG-RDT sensitivity and specificity in selected subgroups during Omicron vs Delta circulation.

Methods

We retrospectively paired AG-RDT results with PCRs registered in Czechia’s Information System for Infectious Diseases from 1 to 25 December 2021 (Delta, n = 20,121) and 20 January to 24 February 2022 (Omicron, n = 47,104).

Results

When confirmatory PCR was conducted on the same day as AG-RDT as a proxy for antigen testing close to peak viral load, the average sensitivity for Delta was 80.4% and for Omicron 81.4% (p < 0.05). Sensitivity in vaccinated individuals was lower for Omicron (OR = 0.94; 95% confidence interval (CI): 0.87–1.03), particularly in reinfections (OR = 0.83; 95% CI: 0.75–0.92). Saliva AG-RDT sensitivity was below average for both Delta (74.4%) and Omicron (78.4%). Tests on the European Union Category A list had higher sensitivity than tests in Category B. The highest sensitivity for Omicron (88.5%) was recorded for patients with loss of smell or taste, however, these symptoms were almost 10-fold less common than for Delta. The sensitivity of AG-RDTs performed on initially asymptomatic individuals done 1, 2 or 3 days before a positive PCR test was consistently lower for Omicron compared with Delta.

Conclusion

Sensitivity for Omicron was lower in subgroups that may become more common if SARS-CoV-2 becomes an endemic virus.

© Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2023.28.38.2200938
2023-09-21
2024-12-22
/content/10.2807/1560-7917.ES.2023.28.38.2200938
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/28/38/eurosurv-28-38-3.html?itemId=/content/10.2807/1560-7917.ES.2023.28.38.2200938&mimeType=html&fmt=ahah

References

  1. Singanayagam A, Hakki S, Dunning J, Madon KJ, Crone MA, Koycheva A, et al. Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study. Lancet Infect Dis. 2022;22(2):183-95.  https://doi.org/10.1016/S1473-3099(21)00648-4  PMID: 34756186 
  2. Vicentini M, Venturelli F, Mancuso P, Bisaccia E, Zerbini A, Massari M, et al. Risk of SARS-CoV-2 reinfection by vaccination status, predominant variant and time from prior infection: a cohort study, Reggio Emilia province, Italy, February 2020 to February 2022. Euro Surveill. 2023;28(13):2200494.  https://doi.org/10.2807/1560-7917.ES.2023.28.13.2200494  PMID: 36995374 
  3. Homza M, Zelena H, Janosek J, Tomaskova H, Jezo E, Kloudova A, 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(9):1567.  https://doi.org/10.3390/diagnostics11091567  PMID: 34573909 
  4. Dinnes J, Sharma P, Berhane S, van Wyk SS, Nyaaba N, Domen J, et al. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2022;7(7):CD013705. PMID: 35866452 
  5. European Commission (EC). EU health preparedness: A common list of COVID-19 rapid antigen tests. 16th update. Brussels: EC; 2022. Available from: https://web.archive.org/web/20220628121228/https://health.ec.europa.eu/system/files/2022-06/covid-19_rat_common-list_en_0.pdf
  6. Kliegr T, Jarkovský J, Jiřincová H, Kuchař J, Karel T, Tachezy R. Role of population and test characteristics in antigen-based SARS-CoV-2 diagnosis, Czechia, August to November 2021. Euro Surveill. 2022;27(33):2100442.  https://doi.org/10.2807/1560-7917.ES.2022.27.33.2200070  PMID: 35983773 
  7. Czech Radio. Pět PCR testů zdarma místo dvou. Ministerstvo chystá od příštího týdne změnu u testování. [Five PCR tests free instead of two. The ministry is preparing a change in testing from next week]. Prague: Czech Radio; 2022. Czech. Available from: https://www.irozhlas.cz/zpravy-domov/koronavirus-kolik-pcr-testu-zdarma-testy-covid-aktualne-cesko_2201111010_ako
  8. National Institute of Health of the Czech Republic (SZU). Charakterizace viru SARS-CoV-2 v České republice dle diskriminačních PCR a celogenomové sekvenace 17.12.2021. [Characterisation of SARS-CoV-2 in Czechia according to discriminatory PCR and whole genome sequencing 17 December 2021]. Prague: SZU; 2021. Czech. Available from: https://web.archive.org/web/20211224173255/http://www.szu.cz/uploads/documents/szu/aktual/SARS_CoV_2_podrobna_zprava_2021_12_17.pdf
  9. National Institute of Health of the Czech Republic (SZU). Charakterizace viru SARS-CoV-2 v České republice dle diskriminačních PCR a celogenomové sekvenace 24. 1. 2022 [Characterisation of SARS-CoV-2 in Czechia according to discriminatory PCR and whole genome sequencing 24 January 2022]. Prague: SZU; 2022. Czech. Available from: https://web.archive.org/web/20220125225720/http://www.szu.cz/uploads/documents/szu/aktual/SARS_CoV_2_podrobna_zprava_SZU_2022_01_24.pdf
  10. National Institute of Health of the Czech Republic (SZU). SARS-Cov-2: epidemiologická a mikrobiologická situace v ČR 14. 2. 2022. [SARS-CoV-2: epidemiological and microbiological situation in the Czech Republic 14 February 2022]. Prague: SZU; 2022. Czech. Available from: https://web.archive.org/web/20220618102452/http://www.szu.cz/uploads/documents/szu/aktual/SARS_CoV_2_podrobna_zprava_SZU_2022_02_14.pdf
  11. Komenda M, Panoška P, Bulhart V, Žofka J, Brauner T, Hak J, et al. Přehled aktuální situace v ČR. Onemocnění aktuálně (incidence-7-14-kraje). [Overview of the current situation in the Czech Republic. Disease Current (region-level incidence)]. Prague: Ministry of Health of the Czech Republic; 2022. Available from: https://onemocneni-aktualne.mzcr.cz/covid-19
  12. European Centre for Disease Prevention and Control (ECDC). Reinfection with SARS-CoV-2: implementation of a surveillance case definition within the EU/EEA. Stockholm: ECDC; 2021. Available from: https://www.ecdc.europa.eu/sites/default/files/documents/Reinfection-with-SARSCoV2-implementation-of-a-surveillance-case-definition.pdf
  13. World Health Organization (WHO). WHO Emergency Use Listing for In vitro diagnostics (IVDs) detecting SARS‐CoV‐2. Geneva: WHO; 2022. Available from: https://extranet.who.int/pqweb/sites/default/files/documents/220607_EUL_SARS-CoV-2_product_list.pdf
  14. Fleiss JL, Levin B, Paik MC. Statistical methods for rates and proportions. Hoboken: Wiley; 2003.
  15. Seabold S, Perktold J. statsmodels: Econometric and statistical modeling with python. Proceedings of the 9th Python in Science Conference. 2010.
  16. Hay JA, Kissler SM, Fauver JR, Mack C, Tai CG, Samant RM, et al. Quantifying the impact of immune history and variant on SARS-CoV-2 viral kinetics and infection rebound: A retrospective cohort study. eLife. 2022;11:e81849.  https://doi.org/10.7554/eLife.81849  PMID: 36383192 
  17. Flinck H, Kerimov D, Luukinen B, Seiskari T, Aittoniemi J. Evaluation of the Roche-SD Biosensor rapid antigen test: Antigen is not reliable in detecting SARS-CoV-2 at the early stage of infection with respiratory symptoms. Diagn Microbiol Infect Dis. 2022;102(4):115628.  https://doi.org/10.1016/j.diagmicrobio.2021.115628  PMID: 35066397 
  18. Bekliz M, Adea K, Puhach O, Perez-Rodriguez F, Marques Melancia S, Baggio S, et al. Analytical sensitivity of eight different SARS-CoV-2 antigen-detecting rapid tests for Omicron-BA.1 variant. Microbiol Spectr. 2022;10(4):e0085322.  https://doi.org/10.1128/spectrum.00853-22  PMID: 35938792 
  19. Puhach O, Adea K, Hulo N, Sattonnet P, Genecand C, Iten A, et al. Infectious viral load in unvaccinated and vaccinated individuals infected with ancestral, Delta or Omicron SARS-CoV-2. Nat Med. 2022;28(7):1491-500.  https://doi.org/10.1038/s41591-022-01816-0  PMID: 35395151 
  20. Office for National Statistics (ONS). Coronavirus (COVID-19) Infection Survey technical article: analysis of reinfections of COVID-19: June 2021. Newport: ONS; 2021. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/articles/coronaviruscovid19infectionsurveytechnicalarticleanalysisofreinfectionsofcovid19/june2021
  21. Woodbridge Y, Amit S, Huppert A, Kopelman NM. Viral load dynamics of SARS-CoV-2 Delta and Omicron variants following multiple vaccine doses and previous infection. Nat Commun. 2022;13(1):6706.  https://doi.org/10.1038/s41467-022-33096-0  PMID: 36344489 
  22. Kam KQ, Maiwald M, Chong CY, Thoon KC, Nadua KD, Loo LH, et al. SARS-CoV-2 antigen rapid tests and universal screening for COVID-19 Omicron variant among hospitalized children. Am J Infect Control. 2023;51(3):255-60.  https://doi.org/10.1016/j.ajic.2022.11.002  PMID: 36370867 
  23. Vihta KD, Pouwels KB, Peto TE, Pritchard E, House T, et al. Omicron-associated changes in SARS-CoV-2 symptoms in the United Kingdom. Clin Infect Dis. 2022;76(3):e133-41. PMID: 35917440 
  24. Marais G, Hsiao NY, Iranzadeh A, Doolabh D, Enoch A, Chu CY, et al. Saliva swabs are the preferred sample for Omicron detection. Medrxiv. 2021; . https://doi.org/10.1101/2021.12.22.21268246 
  25. Komenda M, Panoška P, Bulhart V, Žofka J, Brauner T, Hak J, et al. COVID 19: Přehled aktuální situace v ČR. Onemocnění aktuálně (incidence-7-14-CR). [Overview of the current situation in the Czech Republic. Disease Current (incidence 7-14 Czech Republic)]. [Accessed: 2 May 2023]. Available from: https://onemocneni-aktualne.mzcr.cz/covid-19
  26. World Health Organization (WHO). Statement on the fifteenth meeting of the IHR (2005) Emergency Committee on the COVID-19 pandemic Geneva; WHO; 2023. Available from: https://www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic
  27. Luptakova V, Tachecí B. iRozhlas.cz. 2022 [cited 2023 May 5]. Available from: https://www.irozhlas.cz/zivotni-styl/zdravi/testovani-konvalinka_2201272045_voj.
  28. Puhach O, Meyer B, Eckerle I. SARS-CoV-2 viral load and shedding kinetics. Nat Rev Microbiol. 2023;21(3):147-61. PMID: 36460930 
Can variants, reinfection, symptoms and test types affect COVID-19 diagnostic performance? A large-scale retrospective study of AG-RDTs during circulation of Delta and Omicron variants, Czechia, December 2021 to February 2022
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Tom%C3%A1%C5%A1+Kliegr&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Kliegr Tomáš</a>, <a href="/search?value1=Ji%C5%99%C3%AD+Jarkovsk%C3%BD&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Jarkovský Jiří</a>, <a href="/search?value1=Helena+Ji%C5%99incov%C3%A1&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Jiřincová Helena</a>, <a href="/search?value1=Jaroslav+Kucha%C5%99&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Kuchař Jaroslav</a>, <a href="/search?value1=Tom%C3%A1%C5%A1+Karel&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Karel Tomáš</a>, <a href="/search?value1=David+Chud%C3%A1n&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Chudán David</a>, <a href="/search?value1=Stanislav+Voj%C3%AD%C5%99&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Vojíř Stanislav</a>, <a href="/search?value1=Michal+Zav%C5%99el&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Zavřel Michal</a>, <a href="/search?value1=Ond%C5%99ej+%C5%A0anca&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Šanca Ondřej</a>, <a href="/search?value1=Ruth+Tachezy&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Tachezy Ruth</a></span>. Can variants, reinfection, symptoms and test types affect COVID-19 diagnostic performance? A large-scale retrospective study of AG-RDTs during circulation of Delta and Omicron variants, Czechia, December 2021 to February 2022. <a href="/content/ecdc">Euro Surveill.</a> 2023;28(38):pii=2200938. <a href="https://doi.org/10.2807/1560-7917.ES.2023.28.38.2200938" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2023.28.38.2200938</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 09 Dec 2022;&nbsp;&nbsp; <span class="generated">Accepted</span>: 26 May 2023 </span> </p>
/content/10.2807/1560-7917.ES.2023.28.38.2200938
/content/10.2807/1560-7917.ES.2023.28.38.2200938
Loading

Data & Media loading...

Submit comment
Close
Comment moderation successfully completed
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