Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV)
February 2, 2020
To date, we do not fully understand the pathogenic potential and transmission dynamics of 2019 Novel Coronavirus (2019-nCoV). Until more information becomes available, precautions should be taken in collecting and handling specimens that may contain 2019-nCoV. Timely communication between clinical and laboratory staff is essential to minimize the risk incurred in handling specimens from patients with possible 2019-nCoV 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 2019-nCoV specimens are provided below.
For additional detailed instructions please refer to the following:
- Biosafety in Microbiological and Biomedical Laboratories (BMBL) – Fifth Edition
- Laboratory Biosafety Manual – Third Editionexternal icon
General Guidelines (for working with potentially infectious materials)
Laboratory workers should wear appropriate personal protective equipment (PPE) which includes disposable gloves, laboratory coat/gown and eye protection when handling potentially infectious specimens.
Any procedure with the potential to generate fine-particulate aerosols (e.g., vortexing or sonication of specimens in an open tube) should be performed in a Class II Biological Safety Cabinet (BSC). Appropriate physical containment devices (e.g., centrifuge safety buckets; sealed rotors) should be used for centrifugation. Ideally, rotors and buckets should be loaded and unloaded in a BSC. Perform any procedures outside a BSC in a manner that minimizes the risk of exposure to an inadvertent sample release.
After specimens are processed, decontaminate work surfaces and equipment with appropriate disinfectants. Use any EPA-registered hospital disinfectant. Follow manufacturer’s recommendations for use-dilution (i.e., concentration), contact time, and care in handling.
All disposable waste should be autoclaved.
Specific Guidelines
Virus isolation in cell culture and initial characterization of viral agents recovered in cultures of 2019-nCoV specimens are NOT recommended at this time, except at a BSL3 facility.
The following activities may be performed in BSL-2 facilities using standard BSL-2 work practices:
- Pathologic examination and processing of formalin-fixed or otherwise inactivated tissues
- Molecular analysis of extracted nucleic acid preparations
- Electron microscopic studies with glutaraldehyde-fixed grids
- Routine examination of bacterial and mycotic cultures
- Routine staining and microscopic analysis of fixed smears
- Final packaging of specimens for transport to diagnostic laboratories for additional testing. Specimens should already be in a sealed, decontaminated primary container.
- Inactivated specimens (e.g., specimens in nucleic acid extraction buffer)
The following activities involving manipulation of potentially infected specimens should be, at a minimum, performed as above and in a Class II BSC. A site specific risk assessment should be performed to determine if enhanced biosafety precautions are warranted based on situational needs (e.g. high testing volumes):
- Aliquoting and/or diluting specimens
- Inoculating bacterial or mycological culture media
- Performing diagnostic tests that do not involve propagation of viral agents in vitro or in vivo
- Nucleic acid extraction procedures involving potentially infected specimens
- Preparation and chemical- or heat-fixing of smears for microscopic analysis
Clinical Laboratory Testing
Clinical laboratories performing routine hematology, urinalysis, and clinical chemistry studies, and microbiology laboratories performing diagnostic tests on serum, blood, or urine specimens should follow standard laboratory practices, including Standard Precautions, when handling potential 2019-nCoV specimens. For additional information, see Biosafety in Microbiological and Biomedical Laboratories (BMBL) – Fifth Edition (page 225).
Packing, Shipping and Transport
Packaging, shipping, and transport of specimens from suspect cases or PUI’s of 2019-nCoV infection must follow the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulationsexternal icon.
Follow shipping regulations for UN 3373 Biological Substance, Category B when sending potential 2019-nCoV specimens.
Resources
- Packaging Checklist, see Category B Saf-T-Pakpdf icon
- 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 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 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).
- Schematic for packaging, UN 3373 Category Bpdf icon