COVID-19 Research Biosafety
The information on this page is currently under review.
December 23, 2024 update: The CDC (Centers for Disease Control and Prevention) has updated its biosafety guidance for work with SARS-CoV-2. The CDC now recommends that work with SARS-CoV-2 be conducted at a minimum of biosafety level 2 (BSL-2). The National Institutes of Health (NIH) is aligning by rescinding the interim risk group classification of Risk Group 3 for SARS-CoV-2. The NIH Guidelines now classify SARS-CoV-2 and most other human coronaviruses as Risk Group 2. (SARS-CoV and Middle East Respiratory Syndrome (MERS-CoV) remain classified as RG3 agents and require a minimum of BSL-3 for work.)
At the University of Washington, changes to research involving SARS-CoV-2 still require Biological Use Authorization (BUA) including review and approval by EH&S and the Institutional Biosafety Committee (IBC). EH&S and the IBC are assessing the changes from the CDC and NIH and will make determinations for UW research at the January 2025 IBC meeting. These changes will be communicated to the UW biological research community and will be reflected on the EH&S website.
Principal investigators are required to submit a Biological Use Authorization (BUA) application and obtain approval from the IBC and EH&S before starting research activities involving SARS-CoV-2 virus. This includes work involving the SARS-CoV-2 virus or viral RNA, clinical samples suspected of containing SARS-CoV-2, and fixed or inactivated samples or tissues. See Biological Research Approval for more information and submission deadlines.
Required Biosafety Levels
The following are general biosafety level requirements which are subject to change as we learn more about SARS-CoV-2. Follow all EH&S and IBC requirements as communicated in your BUA Letter. Additional site-specific requirements may be required for certain facilities or shared laboratory spaces.
Summary of Required Biosafety Levels
| Sample or Specimen Type |
Biosafety Level |
Medical Counseling |
| Nucleic acids and fixed/inactivated SARS-CoV-2 samples or tissue |
BSL-2 |
Not required |
| Clinical specimens from COVID-19 patients |
BSL-2 with enhancements |
Required |
| SARS-CoV-2 in vitro and in vivo experiments |
BSL-3 |
Required |
Biosafety level 2 (BSL-2) is required for work with nucleic acids fixed/inactivated SARS-CoV-2 samples or tissues. Perform aerosol-generating activities inside a biosafety cabinet. Wear a lab coat and gloves in addition to appropriate laboratory clothing that covers the legs and closed toe shoes that cover the feet. If there is a potential for splash or spatter, wear face protection that covers the eyes and mucous membranes. An EH&S biosafety officer can work with your lab to implement BSL-2 practices and PPE for this work.
BSL-2 is required for the following activities:
- Flow cytometry of fixed samples
- Staining and microscopic analysis of fixed smears
- Pathologic examination and processing of formalin-fixed or otherwise inactivated tissues (inactivation method should be validated)
- Molecular analysis of extracted nucleic acid preparations (see information on amplicon contamination below in Biosafety Practices)
- Using inactivated specimens, such as specimens in nucleic acid extraction buffer
- Performing electron microscopic studies with glutaraldehyde-fixed grids
Biosafety level 2 (BSL-2) with enhancements is required for work with clinical specimens from known or suspected COVID-19 patients. The following table describes the enhancements required in addition to standard BSL-2 work practices.
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BSL-2 enhancements for work with SARS-CoV-2 clinical samples
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Personal protective equipment (PPE)
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Required PPE in addition to appropriate laboratory clothing that covers the legs and closed toe shoes that cover the feet includes:
- Moisture-resistant procedure mask in combination with eye protection such as safety goggles, close-fitting safety glasses with solid side shields, or chin-length face shields
- Gloves
- Closed-front gown
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Laboratory-specific procedures
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Prepare a site-specific standard operating procedure (SOP) for work with COVID-19 clinical specimens. Train all staff working with clinical specimens on the SOP, and keep documented training logs in the lab.
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Additional signage
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Post a sign on the lab door during work stating that COVID-19 clinical specimens are in use. This is to be posted in addition to the Biohazard Warning sign.
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Heat treatment vs. heat inactivation
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Use the term “heat-treated” rather than “heat inactivated” if your procedures have not been validated. If shipping samples to other labs, include a letter stating the samples have been heat-treated.
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Medical counseling
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Medical counseling must be completed by all personnel handling COVID‑19 clinical specimens. Personnel must contact the Employee Health Center at 206-685-1026 to schedule counseling with an occupational health nurse, and complete the counseling prior to starting work.
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Follow required standard BSL-2 practices including:
- Performance of procedures in a way that minimizes production of aerosols
- Use of a Class II biosafety cabinet (BSC)
- Use of centrifuges with aerosol containment safety cups that are loaded/unloaded inside the BSC
- Decontamination of work surfaces and lab equipment after completion
- Immediate decontamination in the event of a spill or splash
- Treatment and disposal of biohazardous waste by autoclaving or shipping off-site
- Transport of biohazardous materials using leak-proof secondary containers labeled with a biohazard symbol
- Keeping lab doors closed during BSL-2 work with a biohazard warning sign displayed
Biosafety level 3 (BSL-3) is required for working with the SARS-CoV-2 virus that includes isolation, culture and amplification. Use of SARS-CoV-2 in animals requires ABSL-3. Research at BSL-3 includes additional personal protective equipment (PPE) such as respiratory protection as well as engineering controls that provide enhanced containment. Registration and ongoing training with EH&S and the Department of Comparative Medicine (DCM) are also required. To inquire about research in the BSL-3 facility, contact the SLU 3.1 BSL3/ABSL3 Facility by email.
A medical management plan is in place for BSL-3 research with SARS-CoV-2. As part of the plan, all persons working with SARS-CoV-2 at BSL-3 must receive medical counseling from the Employee Health Center prior to work with the virus.
Biosafety Practices for Research with SARS-CoV-2
Each laboratory should perform a site-specific and activity-specific risk assessment to identify and mitigate potential risks prior to starting work. Laboratory hazards include activities that may generate aerosols or splashes, potentially contaminated equipment, and proficiency of staff.
Laboratory SOPs should include information on measures in place to mitigate risks, including training, engineering controls, PPE, appropriate waste collection and treatment, and spill and exposure response procedures.
Gather all needed PPE before starting work, and don in a clean area. Don PPE in the following order:
- Closed-front gown
- Face and eye protection
- Gloves
When doffing, take special care to avoid contamination. Remove PPE in the following order:
- Remove gloves using a method to prevent contamination.
- Remove closed-front gown avoiding forceful movements. Gently pull gown down away from the body or roll down.
- Wash hands or don clean gloves before removing eye and face protection.
- Wash hands.
Do not reuse PPE used for work with biohazards. Dispose of all PPE used for work with biohazards as biohazardous waste. Always wash your hands after removing gloves and after handling any biohazards. See these additional PPE donning and doffing resources:
Transport biohazardous samples and waste in accordance with the UW policies as outlined in the UW Biosafety Manual. When transporting samples within or between buildings on campus, place the primary container inside a leak-proof secondary container. Use only a UW-owned and operated vehicle for transport.
Ensure the Spill Response Poster is posted in the lab. If a spill occurs, follow the EH&S protocol for biohazardous spills. Pay special attention to spills outside of a biosafety cabinet. If a sample suspected of containing COVID-19 is spilled outside of a biosafety cabinet, personnel should leave the room immediately and close the door. Indicate a spill is inside the room so others do not enter. Wait 30 minutes before re-entering the room to allow aerosols to settle.
When polymerase chain reaction (PCR) is used to amplify gene targets, large numbers of amplified nucleic acid molecules, or amplicons, are generated. Nucleic acid amplicons are not infectious or hazardous to human health. However, if not contained, amplicons can potentially contaminate surrounding surfaces and equipment, personnel and research experiments. Contamination is also possible when working with DNA and DNA products such as plasmid preparations.
If SARS‑CoV‑2 nucleic acid contamination reaches one’s nasal passages via inhalation or touching of one’s face with contaminated hands, COVID-19 nasal swab test results may be affected and return as positive or inconclusive, despite the individual not having an active SARS-CoV-2 infection at the time of testing. Such personnel may be asymptomatic with no known exposure to a COVID-19 positive individual. Preventing and managing amplicon contamination is essential to focus public health guidance to those affected by active SARS-CoV-2 infections and to prevent unnecessary isolation or quarantine of those working with SARS‑CoV‑2 nucleic acids or their close contacts.
If your lab uses polymerase chain reaction (PCR) to amplify SARS-CoV-2 gene targets or works with PCR product, plasmid preps or any nucleic acid from SARS-CoV-2, please review our Prevent and Manage Amplicon Contamination in Your Lab Focus Sheet.
Occupational Health Requirements
Medical counseling is required before starting work with SARS-CoV-2 clinical samples. Researchers in the BSL-3 program working with SARS-CoV-2 are required to adhere to the requirements in the medical management plan.
The Principal Investigator or supervisor is required to review any occupational health recommendations or medical management plans with staff and must ensure that their staff contact the Employee Health Center for medical counseling prior to work. Occupational health information and medical management plans will be provided upon research approval.
In the event of an exposure to SARS-CoV-2, follow the steps on the Exposure Response Poster. Report all exposures and near misses via the Online Accident Reporting System (OARS). For researchers in the BSL-3 program, follow any additional program procedures for exposures and symptom development.
Frequently asked question
If your lab work includes handling hazardous materials (or is in an area where hazardous materials are being used) and you want to wear a mask for COVID-19 prevention, wear a disposable medical/procedure mask along with other appropriate PPE.
If you wear a mask for work with biohazards, whether required or by choice, a disposable medical/procedure mask is required at BSL-2 and higher. Do not wear cloth masks during BSL-2 and higher work. Dispose of the mask following work, as it could have become contaminated. You can replace your disposable mask with a clean face covering of your choice if you want to wear a mask outside the lab. Read this article on the EH&S website for more information.
