Introduction: The purpose of this post is to provide interim guidance on laboratory biosafety related to the testing of clinical specimens of patient that meet the case definition of the novel pathogen identified in Wuhan, China, i.e. 2019 novel coronavirus (2019-nCoV), the disease named COVID-19 from the World Health Organization (WHO). As our understanding of the disease caused by 2019-nCoV is limited but rapidly growing, WHO continues to monitor developments and will revise these recommendations as necessary. Note: This is a draft. The content of this document is not final, and the text may be subject to revisions before publication.
Laboratory biosafety: Ensure that health laboratories adhere to appropriate biosafety practices. Any testing for the presence of 2019- nCoV or clinical specimens from patient meeting the suspect case definition should be performed in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. National guidelines on the laboratory biosafety should be followed in all circumstances. General information on laboratory biosafety guidelines, see the WHO Laboratory Biosafety Manual, 3rd edition in the interim before its 4th edition is released.
Highlights of 2019-nCoV laboratory biosafety:
All procedures must be performed based on risk assessment and only by personnel with demonstrated capability in strict observance to 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, NAAT) should be conducted at facilities and procedures equivalent to BSL-2 and propagative work (e.g. virus culture, isolation or neutralization assays) 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 UN3373, “Biological. Substance, Category B”. Viral cultures or isolates should be transported as Category A, UN2814, “infectious substance, affecting humans”.
- Each laboratory should conduct a local (i.e. 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 2019-nCoV infection 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, nucleic acid amplification test (NAAT) on clinical specimens from patients who are suspected or confirmed to be infected with nCoV, should be conducted adopting practices and procedures of “core requirements1 ” and an appropriate selection of “heightened control measures2 ” as informed by the local risk assessment. In the interim, Biosafety Level 2 (BSL-2) in the WHO Laboratory Biosafety Manual, 3rd edition remains appropriate until the 4th 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, i.e. BSL-3.
- Initial processing (before inactivation) of all specimens including those for sequencing and NAAT should take place in an appropriately maintained and validated biological safety cabinet (BSC) or primary containment device.
- Appropriate disinfectants with proven activity against enveloped viruses used for the recommended contact time, 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 UN3373, “Biological. Substance, Category B”. Viral cultures or isolates should be transported as Category A, UN2814, “infectious substance, affecting humans”.
For more detailed information,
download the entire WHO Interim Guidelines here.
©World Health Organization 2020.
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