Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)

Summary of Recent Changes

Revisions made on March 18, 2020 include recommendations for:

  • Shipment of SARS-CoV-2 isolates or cultures as UN 3373 Biological Substance, Category B

March 18, 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.

General Guidance

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.

Specific Guidance

Virus isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2 specimens are NOT recommended at this time, except in a Biosafety Level 3 (BSL-3) laboratory.

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

Decentralized and Point of Care Testing

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).

Procedures with a High Likelihood to Generate Droplets or Aerosols

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.

Decontamination

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.

Laboratory Waste Management

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

Specimen Packing and Shipping

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.

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