Innovative COVID-19 diagnostics and testing strategies in Italy, Denmark, UK, Israel and Sweden: a comparative analysis including tests, incidence and mortality: Innovative COVID-19 diagnostics and testing strategies

Innovative COVID-19 diagnostics and testing strategies in Italy, Denmark, UK, Israel and Sweden: a comparative analysis including tests, incidence and mortality

Innovative COVID-19 diagnostics and testing strategies

Authors

  • Pietro Melodia School of Public Health,Vita-Salute San Raffaele University,IRCCS San Raffaele Scientific Institute, Via Olgettina n.21,Milan, Italy
  • Manuel Stocchi School of Public Health,Vita-Salute San Raffaele University,IRCCS San Raffaele Scientific Institute, Via Olgettina n.21,Milan, Italy
  • Leandro Gentile Department of Public Health, Experimental and Forensic Medicine, University of Pavia, via Forlanini, 2, Pavia Pavia, Italy
  • Anna Odone Department of Public Health, Experimental and Forensic Medicine, University of Pavia, via Forlanini, 2, Pavia Pavia, Italy
  • Cristina Renzi School of Public Health,Vita-Salute San Raffaele University,IRCCS San Raffaele Scientific Institute, Via Olgettina n.21,Milan, Italy
  • Carlo Signorelli School of Public Health,Vita-Salute San Raffaele University,IRCCS San Raffaele Scientific Institute, Via Olgettina n.21,Milan, Italy

Keywords:

SARS-CoV-2, COVID-19, CORONADX, Strategy, Contact tracing

Abstract

Detecting SARS-CoV-2 remains a critical component in the global effort to control COVID-19, particularly with the emergence of variants. Since the outbreak, diagnostic techniques have evolved to meet different contexts and needs. Methods: In this study, we analyzed the use of these techniques in five countries (i.e. Italy, Denmark, the United Kingdom, Sweden, and Israel) based on their specific national testing and contact tracing strategies. We also examined the number of tests performed per week, the positivity rate of tests, and the mortality rate in these populations during the same time periods. These countries were chosen based on the directives of the consortium involved in the CORONADX project.

References

Wu Y, Chen C, Chan Y. The outbreak of COVID-19: An overview. J Chin Med Assoc. 2020; 83(3):217-220. doi: 10.1097/JCMA.0000000000000270.

Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5.

Li Q, Guan X, Wu P, et al. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus–Infected Pneumonia N Engl J Med. 2020; 382:1199-1207, doi: 10.1056/NEJMoa2001316

World Health Organization. Laboratory testing strategy recommendations for COVID-19: interim guidance, 2020; No. WHO/2019-nCoV/lab_testing/2020.1.

Centre for Diseases Control and Prevention. Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing. 2020.

Cheng M., Papenburg J., Desjardins M., et al. Diagnostic Testing for Severe Acute Respiratory Syndrome-Related Corona-virus 2: A Narrative Review. Ann Intern Med. 2020; 172(11):726-734. doi: 10.7326/M20-1301.

World Health Organization. Antigen-detection in the diagnosis of SARS-CoV-2 infection: interim guidance, 2021; No.WHO/2019-nCoV/Antigen_Detection/2021.1.

Riccò M, Ranzieri S, Peruzzi S, et al. Antigen Detection Tests for SARS-CoV-2: a systematic review and meta-analysis

on real world data. Acta Biomed. 2022; 93(2):e2022036. doi: 10.23750/abm.v93i2.11031

Riccò M, Ranzieri S, Marchesi F. Rapid antigen tests for large-scale diagnostic campaigns: A case study from North-Eastern Italy. J Infect. 2021; 82(5):e39-e40. doi: 10.1016/j.jinf.2021.01.011.

Riccò M, Ranzieri S, Peruzzi S, et al. RT-qPCR assays based on saliva rather than on nasopharyngeal swabs are possible but should be interpreted with caution: results from a systematic review and meta-analysis.: Diagnosis of SARS-CoV-2 through salivary fluids. Acta Biomed. 2020;7 91(3):e2020025. doi: 10.23750/abm.v91i3.10020

Riccò M, Ferraro P, Gualerzi G, et al. Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systemat-ic Review and Meta-Analysis of Real-World Data. J Clin Med. 2020; 9, 1515. doi: 10.3390/jcm9051515.

Veroniki A, Tricco A, Watt J et al. Rapid antigen-based and rapid molecular tests for the detection of SARS-CoV-2: a rap-id review with network meta-analysis of diagnostic test accuracy studies. BMC Med. 2023; 21: 110. doi: 10.1186/s12916-023-02810-0

Mohammadie ZE, Akhlaghi S, Samaeinasab S, et al. Clinical performance of rapid antigen tests in comparison to RT-PCR for SARS-COV-2 diagnosis in Omicron variant: a systematic review and meta-analysis. Rev Med Virol. 2023; 33(2):e2428. doi: 10.1002/rmv.2428

Fragkou PC, Moschopoulos CD, Dimopoulou D, et al.; European Society of Clinical Microbiology and Infection Study Group for Respiratory Viruses. Performance of point-of care molecular and antigen-based tests for SARS-CoV-2: a living systematic review and meta-analysis. Clin Microbiol Infect. 2023 Mar;29(3):291-301. doi: 10.1016/j.cmi.2022.10.028.

Public Health England. PHE novel coronavirus diagnostic test rolled out across UK. Published online January 27, 2020. Available from: https://www.gov.uk/government/news/phe-novel-coronavirus-diagnostic-test-rolled-out-across-uk ac-cessed on 6 June 2023

Pallett SJC, Rayment M, Patel A, et al. Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: a prospective multicentre cohort study. Lancet Respir Med. 2020; Sep;8(9):885-894. doi: 10.1016

/S2213-2600(20)30315-5.

Statens Serum Institut. Diagnostik PCR-Test. Available from: https://covid19.ssi.dk/diagnostik. Published online Septem-ber 5, 2022 Accessed on 6 June 2023

Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3):pii=2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045

Transcript for the CDC Telebriefing Update on COVID-19. US Centers for Disease Control and Prevention. Published online February 28, 2020.

Stein R. Coronavirus Testing Backlogs Continue As Laboratories Struggle To Keep Up With Demand. NPR.org. Published online April 2020.

Unitd States Food and Drug Administration (FDA). In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2. Available from: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2. Accessed on 6 June 2023.

Harrington, Cox, Snowdon, et al. Comparison of Abbott ID NOW and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. J Clinic Microb 2020;58(8):e00798-20. doi: 10.1128/JCM.00798-20.

Stephenson, Crabtree , Evans, et al. Validation of the Thermo Scientific™ SARS-CoV-2 RT-PCR Detection Workflow for the Detection of SARS-CoV-2 from Stainless-Steel Environmental Surface Swabs: AOAC Performance Tested Meth-odSM 012103. J AOAC Int. 2021;104(4):935-947. doi: 10.1093/jaoacint/qsab050.

Loeffelholz MJ, Alland D, Butler-Wu SM, et al. Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test. J Clin Microbiol. 2020 Jul 23;58(8):e00926-20. doi: 10.1128/JCM.00926-20.

United States Food and Drug Administration (FDA). Emergency use authorization (EUA) summary Cepheid Xpert Xpress SARS-CoV-2 DoD test. Available from: https://www.fda.gov/media/144793/download#:~:text=The%20Xpert%20Xpress%20SARS%2DCoV%2D2%20DoD%20test%20is%20only,Drug%20Administration's%20Emergency%20Use%20Authorization.&text=The%20Xpert%20Xpress%20SARS%2DCoV%2D2%20DoD%20test%20is%20an,from%20SARS%2DCoV%2D2. Accessed on June 6 2023.

United States Food and Drug Administration (FDA). EUA Authorized Serology Test Performance Available from: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance Accessed on 6 June 2023.

Broder K, Babiker A, Myers C, et al. Test Agreement between Roche Cobas 6800 and Cepheid GeneXpert Xpress SARS-CoV-2 Assays at High Cycle Threshold Ranges. J Clin Micro. 2020;58(8):e01187-20. doi: 10.1128/JCM.01187-20.

United States Food and Drug Administration (FDA). Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epi-demiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. Emergency use of this test is limited to authorized laboratories using the Sofia, Sofia 2 or Sofia Q instruments. Available from: https://www.fda.gov/media/137886/download Accessed on 6 June 2023.

Ho D. Israel's Ben-Gurion University develops one-minute coronavirus test. URL: https://www.eurekalert.org/pub_releases/2020-05/aabu-ome052220.php Accessed on 6 June 2023

Anahtar M, McGrath G, Rabe B, et al. Clinical Assessment and Validation of a Rapid and Sensitive SARS-CoV-2 Test Using Reverse Transcription Loop-Mediated Isothermal Amplification Without the Need for RNA Extraction. Open Fo-rum Infect Dis.2020;21;8(2):ofaa631. doi: 10.1093/ofid/ofaa631.

Lamb L, Bartolone S, Ward E, Chancellor M. Rapid detection of novel coronavirus/Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by reverse transcription-loop-mediated isothermal amplification”. 15 (6): e0234682. 2020;1534682. doi: 10.1371/journal.pone.0234682.

United States Food and Drug Administration (FDA). 6 November 2020. Coronavirus (COVID-19) Update: FDA Au-thorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-detects-neutralizing-antibodies-recent-or Accessed on

June 2023

United States Food and Drug Administration (FDA). 15 December 2020. Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19”. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic Accessed on 6 June 2023

Statens Serum Institut. Variant-PCR-testen (tidl. Delta-PCR-testen). Available from: https://covid19.ssi.dk/diagnostik/delta-pcr-testen Accessed on 6 June 2023

United States Food and Drug Administration (FDA). 17 November 2020. Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home Accessed on 6 June 2023.

Ellume Health. 15 December 2020. FDA Authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test. Available from: https://www.ellumehealth.com/news/fda-authorizes-ellume-covid-19-home-test-as-first-over-the-counter-fully-at-home-diagnostic-test-december-15-2020 Accessed on 6 June 2023

National Institutes of Health (NIH). 15 December 2020. NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA. Available from: https://www.nih.gov/news-events/news-releases/nih-funded-covid-19-home-test-first-receive-over-counter-authorization-fda Accessed on 6 June 2023

Ellume Health. 15 December 2020. FDA Authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test. Available from: https://www.ellumehealth.com/news/fda-authorizes-ellume-covid-19-home-test-as-first-over-the-counter-fully-at-home-diagnostic-test-december-15-2020 Accessed on 6 June 2023

European Centre for Disease Prevention and Control (ECDC). An overview of the rapid test situation for COVID-19 diagnosis in the EU/EEA. 2020 ECDC, Stockholm, Sweden Available from: https://www.ecdc.europa.eu/en/publications-data/overview-rapid-test-situation-covid-19-diagnosis-eueea Accessed on 6 June 2023

Riccò M, Ranzieri S, Peruzzi S, et al. Antigen Detection Tests for SARS-CoV-2: a systematic review and meta-analysis

on real world data. Acta Biomed. 2022;93(2):e2022036. doi: 10.23750/abm.v93i2.11031

Riccò M, Ranzieri S, Marchesi F. Rapid antigen tests for large-scale diagnostic campaigns: A case study from North-Eastern Italy. J Infect. 2021;82(5):e39-e40. doi: 10.1016/j.jinf.2021.01.011.

Downloads

Published

30-08-2023

How to Cite

1.
Melodia P, Stocchi M, Gentile L, Odone A, Renzi C, Signorelli C. Innovative COVID-19 diagnostics and testing strategies in Italy, Denmark, UK, Israel and Sweden: a comparative analysis including tests, incidence and mortality: Innovative COVID-19 diagnostics and testing strategies. Acta Biomed [Internet]. 2023 Aug. 30 [cited 2024 Jul. 17];94(S3):e2023190. Available from: https://mattioli1885journals.com/index.php/actabiomedica/article/view/14565