With the current pandemic of COVID-19, there is a great appeal to laboratories for processing sample materials, diagnostics, but also research into a vaccine against SARS-CoV-2. With regard to working safely (biosafety) with SARS-CoV-2, various documents and guidelines from, among others, RIVM, WHO and CDC have been published. The most important biosafety aspects are further elaborated below. Finally, some biosecurity points for attention are also mentioned.
RIVM/LCI guideline SARS-CoV-2 - biosafety
In the Netherlands, COVID-19 has been designated as a group A notifiable disease as of 28 January 2020. This means that if the disease is suspected, this must be reported immediately to the GGD (Public Health Service) of the patient's place of residence or stay.
Partly based on the WHO advice (see below) and Interim Laboratory Biosafety guidelines of the CDC in the US, the RIVM / National Coordination Centre for Communicable Disease Control (LCI) recommends the following regarding biosafety in the processing of sample materials, diagnostics and clinical chemical determinations:
- All types of respiratory materials and faeces should be considered (potentially) infectious.
- Blood and urine are not considered infectious and can be handled conventionally by clinical chemical and serological laboratories.
- Potential aerosol-forming operations when handling patient materials that may contain infectious virus should be performed under BSL-2 conditions in a Class 2 Biosafety Cabinet.
More information:
- RIVM/LCI guideline SARS-CoV-2 ([ignore]https://lci.rivm.nl/richtlijnen/covid-19)[/ignore]
- RIVM/LCI Additional diagnostics information COVID-19 ([ignore]https://lci.rivm.nl/covid-19/bijlage/aanvullend)[/ignore]
WHO interim guidance for laboratory biosafety related to SARS-CoV-2
On February 12, 2020, WHO published interim guidelines for laboratories related to the testing of clinical sample materials from patients who meet the case definition for coronavirus disease 2019 (COVID-19).
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 definition1 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
- 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 (for example, sequencing, nucleic acid amplification test [NAAT]) should be conducted at a facility using procedures equivalent to Biosafety Level 2 (BSL-2).
- Propagative work (for example, 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 (for example, 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
More information:
- WHO Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans
([ignore]https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance)[/ignore] - Public Health England (PHE) guideline on COVID-19 safe handling and processing for samples in laboratories
([ignore]https://www.gov.uk/government/publications/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories/wuhan-novel-coronavirus-handling-and-processing-of-laboratory-specimens[/ignore]) - Interim Laboratory Biosafety guidelines of the CDC ([ignore]https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html[/ignore])
COGEM advice CGM / 200211-01 regarding the pathogenicity classification and classification of activities with the new coronavirus 2019-nCoV from Wuhan
On February 11, 2020, the Netherlands Commission on Genetic Modification (COGEM) published an advice on the classification and risk classification of activities with genetically modified SARS-CoV-2. Given the nature of the disease causing the virus and the absence of effective prophylaxis or treatment, COGEM recommends classifying SARS-CoV-2 in pathogenicity class 3. COGEM recommends that work with replication competent (GM) SARS-CoV-2 at ML-III (BSL-3) containment level be carried out with the following additional measures:
- Wearing gloves over the sleeves of the work clothes;
- Wearing a mouth and nose mask (P2 or higher specification) and safety goggles.
Meer informatie:
- COGEM advice CGM/200211-01 ([ignore]https://cogem.net/app/uploads/2020/02/200211-01-advies-Pathogeniteitsclassificatie-en-inschaling-van-werkzaamheden-met-het-nieuwe-coronavirus-2019-nCoV-uit-Wuhan.pdf[/ignore]) - Dutch
- GMO Office - Activities with (sequences of) the new coronavirus ([ignore]https://www.ggo-vergunningverlening.nl/nieuws/werkzaamheden-met-sequenties-van-nieuwe-coronavirus[/ignore]) - Dutch
ABSA SARS-CoV-2 Toolbox
The American Biosafety Association (ABSA International) has published a toolbox on SARS-CoV-2 with relevant links to websites and guidelines on laboratory biosafety ([ignore]https://absa.org/covid19toolbox/[/ignore])
Biosecurity aspects of SARS-CoV-2
In addition to working safely with SARS-CoV-2, it is also important that laboratories are aware of potential biosecurity aspects. The Biosecurity Office has published several points of attention on its website (see: [ignore]https://www.bureaubiosecurity.nl/en/pillars-of-good-practice[/ignore]).
With regard to research with the virus and the production of (parts of) SARS-CoV-2, there are guidelines for ordering synthesized viral sequences (e.g. primers for PCR). The International Gene Synthesis Consortium (IGSC) is an industry-led group of gene synthesis companies and organizations. The IGSC has established a Harmonized Screening Protocol to prevent abuse of synthetically produced sequences. By screening the ordered sequences and the customers of gene synthesis companies, the aim is to protect the positive aspects of gene synthesis technology while minimizing the risk of misuse. This awareness should also be taken into account for SARS-CoV-2 sequences.
More information:
- Biosecurity pillars of good practice ([ignore]https://www.bureaubiosecurity.nl/en/pillars-of-good-practice[/ignore])
- Biosecurity Vulnerability Scan ([ignore]https://www.biosecurityvulnerabilityscan.nl[/ignore])
- 10 golden rules of security and safety ([ignore]https://www.bureaubiosecurity.nl/en/information/10-golden-rules-of-security[/ignore])
- International Gene Synthesis Consortium ([ignore]https://genesynthesisconsortium.org/)[/ignore]
- Harmonized Screening Protocol ([ignore]https://genesynthesisconsortium.org/wp-content/uploads/IGSCHarmonizedProtocol11-21-17.pdf)[/ignore]
Webinar Session: COVID-19 - Biosafety & Biosecurity
On May 2nd, 2020, the Research Institute for Tropical Medicine - Biological Risk Management Office
(RITM - BRMO) of the Philippines organized a facebook live webinar on COVID-19: Biosafety & Biosecurity Aspects and Resources. This course was presented by the Biosecurity Office.
Short Description Course
With the current pandemic of COVID-19, there is a great appeal to laboratories for processing sample materials, diagnostics, but also research into a vaccine against SARS-CoV-2. With regard to working safely (biosafety) with SARS-CoV-2, various documents and guidelines from, among others, RIVM, WHO and CDC have been published. The most important biosafety aspects will be further elaborated during the presentation. Finally, different biosecurity points and awareness highlights of working with high risk.
View the course: [ignore]https://www.facebook.com/RITMBRMO/videos/2638941766424803/[/ignore] (video starts at 8:20)
The RITM- BRMO has also other courses on COVID-19: [ignore]https://www.facebook.com/pg/RITMBRMO/videos/[/ignore]
General Information