Difference between revisions of "Journal:Laboratory biosafety guidance related to coronavirus disease (COVID-19)"

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* Appropriate [[personal protective equipment]] (PPE), as determined by a detailed risk assessment, should be worn by all laboratory personnel handling these specimens.  
 
* 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."<ref name="WHOGuidTrans19">{{cite web |url=https://www.who.int/ihr/publications/WHO-WHE-CPI-2019.20/en/ |title=Guidance on regulations for the transport of infectious substances 2019–2020 |work=WHO/WHE/CPI/2019.20 |author=World Health Organization |publisher=World Health Organization |date=January 2019}}</ref>
 
* 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."<ref name="WHOGuidTrans19">{{cite web |url=https://www.who.int/ihr/publications/WHO-WHE-CPI-2019.20/en/ |title=Guidance on regulations for the transport of infectious substances 2019–2020 |work=WHO/WHE/CPI/2019.20 |author=World Health Organization |publisher=World Health Organization |date=January 2019}}</ref>
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==Recommendations addressing minimal/essential working conditions associated with specific manipulations in laboratory settings==
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The additional recommendations provided in this section address the minimal/essential working conditions associated with specific manipulations in laboratory settings.
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===1. Risk assessment===
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Risk assessment is a systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release of workplace hazard(s) and determining the appropriate risk control measures to reduce the risk to an acceptable level. It is important to note that hazards alone do not pose a risk to humans or animals. Consideration therefore must also be given to the types of equipment used and the procedure(s) that will be performed with the [[biological agent]].
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It is highly recommended to start by performing a local risk assessment for each process step, that is, from sample collection, sample reception, clinical testing, and [[polymerase chain reaction]] (PCR) to virus isolation (only when and where applicable). Certain hazards will then be considered for each process step, such as aerosol exposure during sample processing; eye splash during sample processing; infectious culture material spill; and leaking sample (in the case of sample reception), with an assessed grade of risk. For each identified risk, appropriate risk control measures—including but not limited to the following recommendations—should be selected and implemented to mitigate the residual risks to an acceptable level.
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A risk assessment template is provided in Annex II; this is intended to serve as an example and to facilitate the process.
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===2. Routine laboratory procedures, including non-propagative diagnostic work and PCR analysis===
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Non-culture-based diagnostic laboratory work and PCR analysis on clinical specimens from patients who are suspected or confirmed to be infected with the virus responsible for COVID-19 should be conducted adopting practices and procedures described for conventional clinical and microbiology laboratories, as described in the core requirements (see Annex I).
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However, all manipulations of potentially infectious materials, including those that may cause splashes, droplets, or aerosols of infectious materials (e.g., loading and unloading of sealed centrifuge cups, grinding, blending, vigorous shaking or mixing, sonic disruption, opening of containers of infectious materials whose internal pressure may be different from the ambient pressure) should be performed in appropriately maintained and validated BSCs or primary containment devices, by personnel with demonstrated capability.
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Examples of routine laboratory procedures include:
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* diagnostic testing of serum; blood (including haematology and clinical chemistry); respiratory specimens such as [[Pharynx#Structure|nasopharyngeal and oropharyngeal]] swabs, sputum and/or endotracheal [[Suction (medicine)|aspiration]] or [[bronchoalveolar lavage]]; stool; or other specimens
 +
* routine examination of mycotic and bacterial cultures developed from respiratory tract specimens (Note: When handling and processing specimens, core requirements [see Annex I], including GMPP, should be followed at all times, including but not limited to those under the following subheadings. More details are explained and demonstrated in the WHO's biosafety video series.<ref name="WHOBiosafetyVid05">{{cite web |url=https://www.who.int/ihr/publications/biosafety-video-series/en/ |title=Biosafety video series |work=Strengthening health security by implementing the International Health Regulations (2005) |author=World Health Organization |publisher=World Health Organization |date=2005}}</ref>)
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==Notes==
 
==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 [https://www.who.int/about/who-we-are/publishing-policies/copyright 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).
+
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. A citation concerning the fourth edition of WHO's ''Laboratory Biosafety Manual'' was added for this version. Per the WHO's [https://www.who.int/about/who-we-are/publishing-policies/copyright 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).
  
 
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Revision as of 20:16, 23 March 2020

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]

Recommendations addressing minimal/essential working conditions associated with specific manipulations in laboratory settings

The additional recommendations provided in this section address the minimal/essential working conditions associated with specific manipulations in laboratory settings.

1. Risk assessment

Risk assessment is a systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release of workplace hazard(s) and determining the appropriate risk control measures to reduce the risk to an acceptable level. It is important to note that hazards alone do not pose a risk to humans or animals. Consideration therefore must also be given to the types of equipment used and the procedure(s) that will be performed with the biological agent.

It is highly recommended to start by performing a local risk assessment for each process step, that is, from sample collection, sample reception, clinical testing, and polymerase chain reaction (PCR) to virus isolation (only when and where applicable). Certain hazards will then be considered for each process step, such as aerosol exposure during sample processing; eye splash during sample processing; infectious culture material spill; and leaking sample (in the case of sample reception), with an assessed grade of risk. For each identified risk, appropriate risk control measures—including but not limited to the following recommendations—should be selected and implemented to mitigate the residual risks to an acceptable level.

A risk assessment template is provided in Annex II; this is intended to serve as an example and to facilitate the process.

2. Routine laboratory procedures, including non-propagative diagnostic work and PCR analysis

Non-culture-based diagnostic laboratory work and PCR analysis on clinical specimens from patients who are suspected or confirmed to be infected with the virus responsible for COVID-19 should be conducted adopting practices and procedures described for conventional clinical and microbiology laboratories, as described in the core requirements (see Annex I).

However, all manipulations of potentially infectious materials, including those that may cause splashes, droplets, or aerosols of infectious materials (e.g., loading and unloading of sealed centrifuge cups, grinding, blending, vigorous shaking or mixing, sonic disruption, opening of containers of infectious materials whose internal pressure may be different from the ambient pressure) should be performed in appropriately maintained and validated BSCs or primary containment devices, by personnel with demonstrated capability.

Examples of routine laboratory procedures include:

  • diagnostic testing of serum; blood (including haematology and clinical chemistry); respiratory specimens such as nasopharyngeal and oropharyngeal swabs, sputum and/or endotracheal aspiration or bronchoalveolar lavage; stool; or other specimens
  • routine examination of mycotic and bacterial cultures developed from respiratory tract specimens (Note: When handling and processing specimens, core requirements [see Annex I], including GMPP, should be followed at all times, including but not limited to those under the following subheadings. More details are explained and demonstrated in the WHO's biosafety video series.[5])



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/. 
  5. World Health Organization (2005). "Biosafety video series". Strengthening health security by implementing the International Health Regulations (2005). World Health Organization. https://www.who.int/ihr/publications/biosafety-video-series/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. A citation concerning the fourth edition of WHO's Laboratory Biosafety Manual was added 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).