Novel Coronavirus from Wuhan, China (2019-nCoV)

Biosafety Advisory

This biosafety advisory is being provided by the Public Health Agency of Canada (PHAC) to assist clinical, diagnostic, and research laboratories in implementing proper biosafety procedures where samples containing the novel coronavirus that originated in Wuhan, China (referred to as 2019‑nCoV) are handled. The 2019‑nCoV is responsible for an outbreak of viral pneumonia that began in China in December 2019. This advisory is based on currently available scientific evidence as of January 27, 2020 and is subject to review and change as new information becomes available. The 2019‑nCoV has been classified as a Risk Group 3 (RG3) human pathogen by the Centre for Biosecurity.

This document is intended to support local risk assessments (LRA), particularly for diagnostic laboratories. Laboratories receiving specimens from patients under investigation for 2019‑nCoV must be aware that improper handling of these specimens may pose a serious risk to the health of personnel and the community.

1.0 Background

The first reports of viral pneumonia of unknown etiology surfaced in Wuhan, China in December 2019.Footnote 1 Diagnostic laboratories have since been able to determine that a novel coronavirus (2019‑nCoV) is responsible.Footnote 2 The genetic sequence of the 2019‑nCoV has been made publicly available to inform the development of diagnostic tests.Footnote 3 Common symptoms of 2019‑nCoV infection in humans include fever, respiratory symptoms (e.g., cough, shortness of breath, breathing difficulties), and pneumonia.Footnote 4 Human-to-human transmission has been confirmed, as evidenced by the transmission of the 2019‑nCoV to health care workers and individuals in close contact with infected patients.Footnote 5 Refer to the World Health Organization’s (WHO) website for additional information on the number of confirmed cases.

Some of the patients in the outbreak in Wuhan, China, reportedly had links to a large seafood and animal market, suggesting a possible zoonotic origin of their infection.Footnote 6 The oversight of activities with 2019‑nCoV remains under the PHAC’s purview. Should new information result in the classification of 2019‑nCoV as an emerging animal pathogen, this advisory will be updated to include the Canadian Food Inspection Agency’s regulatory perspective.

At time of publication of this advisory, suspect patients have been identified and hospitalized in a number of countries outside of China.Footnote 7 The WHO reports that travel-associated cases of 2019‑nCoV have been confirmed (e.g., in Australia, in France, in the United States of America, in Canada).Footnote 8 Further identification of travelers infected with 2019‑nCoV in other countries may be expected as countries are on alert for 2019‑nCoV.

2.0 Biosafety Requirements

The following table summarizes the appropriate minimum containment requirements for laboratories where 2019‑nCoV is handled or stored. As an RG3 human pathogen, all propagative in vitro activities and in vivo activities with 2019‑nCoV are to be performed in accordance with a licence issued under the Human Pathogens and Toxins Act (HPTA) and in a facility that meets the minimum applicable requirements for Containment Level 3 (CL3), as specified in the Canadian Biosafety Standard(CBS).Footnote 9 If 2019-nCoV is in a primary specimen it is excluded from the HPTA unless it has been cultivated or intentionally collected or extracted. Where 2019-nCoV is cultivated or intentionally collected or extracted from a primary specimen, these controlled activities as defined in the HPTA are to be performed in accordance with a licence issued under the HPTA and in a facility that meets the containment level requirements described in Table 1.

Primary specimens will generally contain much lower concentrations of pathogen than found in cultures (i.e., propagated pathogens). Examples of primary specimens include blood, plasma, and tissues that are collected directly from patients. Diagnostic specimens from naturally exposed animals (i.e., not resulting from in vivo studies) are also considered primary specimens. Examples of excluded activities with primary specimens may include nucleic acid extraction, molecular testing of nucleic acids, and antigen and antibody assays.

To reduce risks of exposure to personnel and the community, diagnostic or clinical activities involving primary specimens that may contain 2019‑nCoV should be performed at CL2 with additional precautions as determined by an LRA (such as the additional biosafety requirements described in Section 3.0).

Table 1: Canadian containment level requirements for 2019‑nCoV
Sample Type and Activity Minimum Containment Level Required

Table Footnotes

Table Footnote 1

With additional biosafety requirements as described in Section 3.0

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Table Footnote 2

Work in small animal containment zones (SA zones) must meet the applicable requirements in the CL3 column of the CBS and work in large animal containment zones (LA zones) must meet the applicable requirements in the CL3-Ag column of the CBS.

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Non-propagative clinical or diagnostic activities
Examples of these activities include, but are not limited to:

  • procedures with human or animal diagnostic specimens to concentrate or isolate 2019‑nCoV (e.g., ultracentrifugation of plasma sample).

CL2Footnote 1

Propagative in vitro activities
Examples of these activities include, but are not limited to:

  • culturing specimens (e.g., propagated virus);
  • preparatory work for in vivo activities; and
  • processing a culture (i.e., propagated or cultivated) known to contain 2019-nCoV for packaging and distribution to laboratories.

CL3

In vivo work activities
Examples of these activities include, but are not limited to:

  • preparing inoculum;
  • inoculating animals; and
  • collecting specimens from experimentally infected animals.

CL3Footnote 2

The PHAC will continue to monitor this situation and will update this advisory based on new information, if appropriate. Should new information result in a change in risk group classification or the publication of a biosafety directive, such information will be reflected in the ePathogen ‑ Risk Group Database.Footnote 10

3.0 Additional Biosafety Requirements

The applicable CL2 requirements specified in the CBS and the additional biosafety requirements below are to be followed if activities result in the intentional collection, extraction, or concentration of 2019-nCoV from a primary specimen. The following requirements may also be implemented as biosafety precautions (based on an LRA) in facilities where activities excluded from the HPTA are conducted with primary specimens that may contain 2019‑nCoV.

Many of the requirements in the CBS are risk- and performance-based and, as such, are dependent on an LRA being performed. Based on the risks associated with the propagative in vitro activities and in vivo work activities taking place with 2019‑nCoV, additional biosafety measures may also be applicable at CL3. Facilities are to conduct an LRA for the activities to be undertaken with 2019‑nCoV to determine the appropriate risk mitigation measures (CBS R4.1.8), and update the LRA and mitigation measures as new information becomes available.

4.0 Transportation

Packaging, shipping, and transport of specimens of 2019‑nCoV must comply with the requirements of the Transportation of Dangerous Goods Act and the Transportation of Dangerous Goods Regulations.Footnote 11

Transportation by air must comply with the requirements of the Technical Instructions for the Safe Transport of Dangerous Goods by Air, published by the International Civil Aviation Organization (ICAO).Footnote 12

For shipments by road, rail, vessel, and air:

For questions regarding the packaging, shipping, and transport of cultures or primary specimens, contact Transport Canada at TDG-TMD@tc.gc.ca or visit the Transport Canada Transportation of Dangerous Goods website.

In the event of an emergency involving dangerous goods, call CANUTEC at 1-888-CANUTEC (226-8832), 613-996-6666 or *666 on a cellular phone.

5.0 Contact Information

This advisory is based on currently available scientific evidence and is subject to review and change as new information becomes available. Further biosafety information may be obtained:

6.0 References and Resources

Footnotes

Footnote 1

ProMED-mail. (2019). Undiagnosed pneumonia - China (HU) RFI.

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Footnote 2

ProMED-mail. (2020d). Undiagnosed pneumonia - China (Hubei) (05): Novel Coronavirus Identified.

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Footnote 3

GenBank. (2020). Wuhan seafood market pneumonia virus isolate Wuhan-Hu-1, complete genome. Retrieved 01/20, 2020 from https://www.ncbi.nlm.nih.gov/nuccore/MN908947

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Footnote 4

World Health Organization. (2020). Coronavirus. Retrieved 01/20, 2020 from https://www.who.int/health-topics/coronavirus

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Footnote 5

World Health Organization. (2020). Novel Coronavirus – Republic of Korea (ex-China). Retrieved 01/21, 2020 from https://www.who.int/csr/don/21-january-2020-novel-coronavirus-republic-of-korea-ex-china/en/

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Footnote 6

ProMED-mail. (2020d). Undiagnosed pneumonia - China (Hubei) (05) : Novel Coronavirus Identified.

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Footnote 7

World Health Organization. (2020). Novel Coronavirus (2019-nCoV) situation reports. Retrieved 01/29, 2020 from https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports

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Footnote 8

World Health Organization. (2020). Novel Coronavirus. Retrieved 01/20, 2020 from https://www.who.int/westernpacific/emergencies/novel-coronavirus

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Footnote 9

Government of Canada. (2015). Canadian Biosafety Standard, 2nd edition, 2015. Available from https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines/second-edition.html

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Footnote 10

Government of Canada. ePATHogen - Risk Group Database. Available from http://health.canada.ca/en/epathogen

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Footnote 11

Transportation of Dangerous Goods Regulations (SOR/2001-286). (2015).

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Footnote 12

International Civil Aviation Organization (ICAO). (2015). Technical Instructions for the Safe Transport of Dangerous Goods by Air.

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