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Abstract

Laboratory preparedness with quality-assured diagnostic assays is essential for controlling the current coronavirus disease (COVID-19) outbreak. We conducted an external quality assessment study with inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) samples to support clinical laboratories with a proficiency testing option for molecular assays. To analyse SARS-CoV-2 testing performance, we used an online questionnaire developed for the European Union project RECOVER to assess molecular testing capacities in clinical diagnostic laboratories.

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/content/10.2807/1560-7917.ES.2020.25.27.2001223
2020-07-09
2020-08-11
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2020.25.27.2001223
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References

  1. European Centre for Disease Prevention and Control (ECDC). Laboratory support for COVID-19 in the EU/EEA. Stockholm: ECDC. [Accessed: 25 May 2020]. Available from: https://www.ecdc.europa.eu/en/novel-coronavirus/laboratory-support
  2. World Health Organization (WHO). 2019 novel coronavirus (2019-nCoV): strategic preparedness and response plan. Geneva: WHO. [Accessed: 14 Apr 2020]. Available from: https://www.who.int/publications-detail/strategic-preparedness-and-response-plan-for-the-new-coronavirus
  3. World Health Organization (WHO). Molecular assays to diagnose COVID-19: Summary table of available protocols. Geneva: WHO. [Accessed: 21 Apr 2020]. Available from: https://www.who.int/publications/m/item/molecular-assays-to-diagnose-covid-19-summary-table-of-available-protocols
  4. Foundation for Innovative New Diagnostics (FIND). COVID-19 diagnostics resource centre. Geneva: FIND. [Accessed: 25 May 2020]. Available from: https://www.finddx.org/covid-19/
  5. World Health Organization (WHO). Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases. Geneva: WHO; 19 Mar 2020. Available from: https://www.who.int/publications-detail/laboratory-testing-for-2019-novel-coronavirus-in-suspected-human-cases-20200117
  6. Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DKW, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3):2000045.  https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045  PMID: 31992387 
  7. Drosten C, Doerr HW, Lim W, Stöhr K, Niedrig M. SARS molecular detection external quality assurance. Emerg Infect Dis. 2004;10(12):2200-3. . Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3323363/pdf/04-0416.pdf https://doi.org/10.3201/eid1012.040416  PMID: 15663861 
  8. US Food and Drug Administration (FDA). Coronavirus disease 2019 (COVID-19) EUA information. Silver Spring: FDA. [Accessed: 2 Jun 2020]. Available from: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev
  9. Wang X, Yao H, Xu X, Zhang P, Zhang M, Shao J, et al. Limits of detection of 6 approved RT-PCR kits for the novel SARS-coronavirus-2 (SARS-CoV-2). Clin Chem. 2020;66(7):977-9.  https://doi.org/10.1093/clinchem/hvaa099  PMID: 32282874 
  10. Pfefferle S, Reucher S, Nörz D, Lütgehetmann M. Evaluation of a quantitative RT-PCR assay for the detection of the emerging coronavirus SARS-CoV-2 using a high throughput system. Euro Surveill. 2020;25(9):2000152.  https://doi.org/10.2807/1560-7917.ES.2020.25.9.2000152  PMID: 32156329 
  11. Matheeussen V, Loens K, Lammens C, Vilken T, Koopmans M, Goossens H, et al. Preparedness of European diagnostic microbiology labs for detection of SARS-CoV-2, March 2020. J Clin Virol. 2020;128:104432.  https://doi.org/10.1016/j.jcv.2020.104432  PMID: 32422569 
  12. Quality Control for Molecular Diagnostics (QCMD). Respiratory special. Glasgow: QCMD; 2020 [Accessed 25 June 2020]. Available from: https://www.qcmd.org/#fragment-2
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