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Full article title Laboratory biosafety guidance related to coronavirus disease (COVID-19): Interim guidance, 19 March 2020
Author(s) World Health Organization; Blacksell, Stuart; Summermatter, Kathrin; Kojima, Kazunobu; Zinsky, Rica; Ogloi, Zsofia
Author affiliation(s) Mahidol Oxford Tropical Medicine Research Unit, University of Bern's Institute for Infectious Diseases, World Health Organization
Year published 2020
Volume and issue 2020.2
Page(s) 1–11
Distribution license Attribution-NonCommercial-ShareAlike 3.0 IGO
Website https://apps.who.int/iris/handle/10665/331500
Download https://apps.who.int/iris/bitstream/handle/10665/331500/WHO-WPE-GIH-2020.2-eng.pdf (PDF)

Background

The purpose of this document is to provide interim guidance on laboratory biosafety related to the testing of clinical specimens of patients that meet the case definition of the novel pathogen identified in Wuhan, China, that is, coronavirus disease 2019 or COVID-19. The World Health Organization (WHO) will revise these recommendations as necessary.

The following are highlights of COVID-19 laboratory biosafety, discussed in more detail herein:

  • All procedures must be performed based on risk assessment and only by personnel with demonstrated capability, in strict observance of any relevant protocols at all times.
  • Initial processing (before inactivation) of all specimens should take place in a validated biological safety cabinet (BSC) or primary containment device.
  • Non-propagative diagnostic laboratory work (e.g., sequencing, nucleic acid amplification test [NAAT]) should be conducted at a facility using procedures equivalent to biosafety level two (BSL-2).
  • Propagative work (e.g., virus culture, isolation or neutralization assays) should be conducted at a containment laboratory with inward directional airflow (BSL-3).
  • Appropriate disinfectants with proven activity against enveloped viruses should be used (e.g., hypochlorite [bleach], alcohol, hydrogen peroxide, quaternary ammonium compounds, and phenolic compounds).
  • Patient specimens from suspected or confirmed cases should be transported as UN 3373, “Biological Substance, Category B.” Viral cultures or isolates should be transported as Category A, UN 2814, “Infectious Substance, Affecting Humans."

Laboratory biosafety

It is essential to ensure that health laboratories adhere to appropriate biosafety practices. Any testing for the presence of the virus responsible for COVID-19 or of clinical specimens from patients meeting the suspected case definition[1] should be performed in appropriately equipped laboratories, by staff trained in the relevant technical and safety procedures. National guidelines on laboratory biosafety should be followed in all circumstances. For general information on laboratory biosafety guidelines, see the WHO's Laboratory Biosafety Manual, Third Edition[2] (a fourth edition is still in revision[3])

Key points

  • Each laboratory should conduct a local (that is, institutional) risk assessment to ensure it is competent to safely perform the intended testing with appropriate risk control measures in place.
  • When handling and processing specimens, including blood for serological testing, laboratory practices and procedures that are basic to good microbiological practices and procedures (GMPP) should be followed.
  • The handling and processing of specimens from cases with suspected or confirmed COVID-19 infection that are intended for additional laboratory tests, such as haematology or blood gas analysis, should follow local guidelines for processing potentially infectious material.
  • Non-propagative diagnostic laboratory work, including sequencing and NAAT, on clinical specimens from patients who are suspected or confirmed to be infected with COVID-19, should be conducted adopting the practices and procedures of core requirements[a], (see Annex I), and an appropriate selection of heightened control measures[b], as informed by the local risk assessment. In the interim, the use of BSL-2—as described in the third edition of the WHO's Laboratory Biosafety Manual[2]—remains appropriate until the fourth edition replaces it.
  • Handling of material with high concentrations of live virus (such as when performing virus propagation, virus isolation, or neutralization assays) or large volumes of infectious materials should be performed only by properly trained and competent personnel in laboratories capable of meeting additional essential containment requirements and practices, that is, BSL-3.
  • Initial processing (before inactivation) of all specimens, including those for sequencing and NAAT, should take place in an appropriately maintained and validated BSC or primary containment device.
  • Appropriate disinfectants with proven activity against enveloped viruses should be used for the recommended contact time, at the correct dilution, and within the expiry date after the working solution is prepared.
  • All technical procedures should be performed in a way that minimizes the generation of aerosols and droplets.
  • Appropriate personal protective equipment (PPE), as determined by a detailed risk assessment, should be worn by all laboratory personnel handling these specimens.
  • Patient specimens from suspected or confirmed cases should be transported as UN 3373, “Biological Substance, Category B.” Viral cultures or isolates should be transported as Category A, UN 2814, “Infectious Substance, Affecting Humans."[4]


Footnotes

  1. Core requirements: A set of minimum requirements defined in the upcoming fourth edition of the WHO's Laboratory Biosafety Manual to describe a combination of risk control measures that are both the foundation for, and an integral part of, laboratory biosafety. These measures reflect international standards and best practice in biosafety that are necessary to work safely with biological agents, even where the associated risks are minimal.
  2. Heightened control measures: A set of risk control measures that may need to be applied in a laboratory facility because the outcome of a risk assessment indicates that the biological agents being handled and/or the activities to be performed with them are associated with a relatively high risk that cannot be acceptable solely with the core requirements.

References

  1. World Health Organization (20 March 2020). "Global surveillance for COVID-19 caused by human infection with COVID-19 virus: Interim guidance, 20 March 2020". WHO/2019-nCoV/SurveillanceGuidance/2020.6. World Health Organization. https://apps.who.int/iris/handle/10665/331506. 
  2. 2.0 2.1 World Health Organization (2004) (3rd ed.). World Health Organization. ISBN 9241546506. 
  3. Kojima, K. (07 February 2019). "WHO Laboratory Biosafety Manial Revision Update". SlideShare. World Health Organization. https://www.slideshare.net/MicrobiologySection/who-laboratory-biosafety-manual-revision-update. 
  4. World Health Organization (January 2019). "Guidance on regulations for the transport of infectious substances 2019–2020". WHO/WHE/CPI/2019.20. World Health Organization. https://www.who.int/ihr/publications/WHO-WHE-CPI-2019.20/en/. 

Notes

This presentation is faithful to the original, with some changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added. Added an external link to WHO's GMPP video series for this version. Per the WHO's licensing agreement, this reproduction acknowledges the World Health Organization as the source, licensed under the CC BY-NC-SA 3.0 IGO license (see the infobox at top for full details).