Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)
Revisions made on March 31, 2020 include recommendations for:
- Environmental Specimen testing guidance related to procedures that concentrate viruses
March 31, 2020
Until more information becomes available, precautions should be taken in handling specimens that are suspected or confirmed for SARS-CoV-2. Timely communication between clinical and laboratory staff is essential to minimize the risk incurred in handling specimens from patients with possible SARS-CoV-2 infection. Such specimens should be labeled accordingly, and the laboratory should be alerted to ensure proper specimen handling. General and specific biosafety guidelines for handling SARS-CoV-2 specimens are provided below. For additional information on handling SARS-CoV-2 specimens, refer to the Laboratory Biosafety Frequently Asked Questions.
All laboratories should perform a site-specific and activity-specific risk assessment to identify and mitigate risks. Risk assessments and mitigation measures are dependent on:
- The procedures performed
- Identification of the hazards involved in the process and/or procedures
- The competency level of the personnel who perform the procedures
- The laboratory equipment and facility
- The resources available
Follow Standard Precautions when handling clinical specimens, all of which may contain potentially infectious materials. Standard Precautions include hand hygiene and the use of personal protective equipment (PPE), such as laboratory coats or gowns, gloves, and eye protection.
Follow routine laboratory practices and procedures for decontamination of work surfaces and management of laboratory waste.
Routine diagnostic testing of specimens, such as the following activities, can be handled in a BSL-2 laboratory using Standard Precautions:
- Using automated instruments and analyzers
- Processing initial samples
- Staining and microscopic analysis of fixed smears
- Examination of bacterial cultures
- Pathologic examination and processing of formalin-fixed or otherwise inactivated tissues
- Molecular analysis of extracted nucleic acid preparations
- Final packaging of specimens for transport to diagnostic laboratories for additional testing (specimens should already be in a sealed, decontaminated primary container)
- Using inactivated specimens, such as specimens in nucleic acid extraction buffer
- Performing electron microscopic studies with glutaraldehyde-fixed grids
For diagnostic testing of specimens conducted outside of a BSL-2 laboratory, such as rapid respiratory testing performed at the point of care, use Standard Precautions to provide a barrier between the specimen and personnel during specimen manipulation. For additional information on specimen collection, handling, and testing refer to Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs).
For procedures with a high likelihood to generate aerosols or droplets, use either a certified Class II Biological Safety Cabinet (BSC) or additional precautions to provide a barrier between the specimen and personnel. Examples of these additional precautions include personal protective equipment (PPE), such as a surgical mask or face shield, or other physical barriers, like a splash shield; centrifuge safety cups; and sealed centrifuge rotors to reduce the risk of exposure to laboratory personnel.
Site- and activity-specific biosafety risk assessments should be performed to determine if additional biosafety precautions are warranted based on situational needs, such as high testing volumes, and the likelihood to generate infectious droplets and aerosols.
Procedures that concentrate viruses, such as precipitation or membrane filtration, can be performed in a BSL-2 laboratory with unidirectional airflow and BSL-3 precautions, including respiratory protection and a designated area for donning and doffing PPE. The donning and doffing space should not be in the workspace. Work should be performed in a certified Class II BSC.
This guidance is intended for only those laboratories that perform virus concentration procedures, such as wastewater/sewage surveillance testing, not public health or clinical diagnostic laboratories that handle COVID-19 clinical specimens or laboratories that perform culture and isolation of SARS-CoV-2. Site- and activity-specific biosafety risk assessments should be performed to determine if additional biosafety precautions are warranted based on situational needs, such as high testing volumes or large volumes, and the likelihood to generate infectious droplets and aerosols.
Virus isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2 specimens should only be conducted in a Biosafety Level 3 (BSL-3) laboratory using BSL-3 practices. Site- and activity-specific biosafety risk assessments should be performed to determine if additional biosafety precautions are warranted based on situational needs.
Decontaminate work surfaces and equipment with appropriate disinfectants. Use EPA-registered hospital disinfectants with label claims to be effective against SARS-CoV-2external icon. Follow manufacturer’s recommendations for use, such as dilution, contact time, and safe handling.
Handle laboratory waste from testing suspected or confirmed COVID-19 patient specimens as all other biohazardous waste in the laboratory. Currently, there is no evidence to suggest that this laboratory waste needs any additional packaging or disinfection procedures
Pack and ship suspected and confirmed SARS-CoV-2 patient specimens, cultures, or isolates as UN 3373 Biological Substance, Category B, in accordance with the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulationsexternal icon. Personnel must be trained to pack and ship according to the regulations and in a manner that corresponds to their function-specific responsibilities.
- CDC Laboratory Biosafety Frequently Asked Questions
- EPA List N: Disinfectants for Use Against SARS-CoV-2external icon
- Saf-T-Pak Packaging Checklist, see Category Bpdf icon
- IATA Packing Instructions 650 for UN 3373external icon
- Click on “Infectious substances” and there is an option to download the packing instructions.
- Labels for UN 3373
- When using cold pack (CDC)pdf icon – Include the name and telephone number of the person who will be available during normal business hours who knows the content of the shipment (can be someone at CDC). Place the label on one side of the box and cover the label completely with clear tape (do not tape just the edges of the label).
- When using dry ice (CDC)pdf icon – Include the name and telephone number of the person who will be available during normal business hours who knows the content of the shipment (can be someone at CDC). Place the label on one side of the box and cover the label completely with clear tape (do not tape just the edges of the label).
- CDC Schematic for packaging, UN 3373 Category Bpdf icon
- WHO Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV)pdf iconexternal icon
- APHL Risk Assessment Best Practicespdf iconexternal icon
- WHO Laboratory Biosafety Manual, 3rdpdf iconexternal icon
- WHO Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV)-World Health Organizationpdf iconexternal icon
- CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settingspdf icon
- CDC Isolation Precautions