Biosafety Advisory: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

July 7, 2015

This biosafety advisory is being provided by the Public Health Agency of Canada (the Agency) to assist laboratories in implementing proper biosafety procedures when handling samples containing Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly Human Coronavirus Erasmus Medical Centre (HCoV-EMC/2012). The Risk Group (RG) of MERS-CoV is RG3.

1. Background

Coronaviruses belong to a family of viruses that can infect a variety of mammalian hosts. Coronaviruses are readily transmissible among humans by direct contact with respiratory secretions, body fluids and excretions from infected individuals.^{Footnote 1} In humans, coronaviruses are mainly responsible for the common cold; however, the severe acute respiratory syndrome coronavirus (SARS-CoV) can cause severe respiratory illness. Genetic sequence data indicate that MERS-CoV is a beta-coronavirus similar to bat coronaviruses, but distinct from SARS-CoV.^{Footnote 2}

MERS-CoV was discovered in Saudi Arabia in 2012, and, as of June 9 , 2015 , has caused severe respiratory illness in 1218 laboratory-confirmed human cases, of which at least 449 resulted in death. Please visit the Global Alert and Response website for the latest case counts.^{Footnote 3} The current pattern of infection appears to be the result of repeated introduction of MERS-CoV from camels to humans, with limited secondary human-to-human transmission. The source of primary infection with MERS-CoV appears to be zoonotic exposure, with evidence pointing to camels as reservoirs or intermediate hosts for the virus; however, the route of transmission is unknown.^{Footnote 3},^{Footnote 4} MERS-CoV has a relatively broad cellular host range, which may indicate that a variety of wild and domesticated animal reservoirs are possible.^{Footnote 5} Human-to-human infections can result from situations involving close contact, such as among family and household members, and in health care settings. To date, MERS-CoV has demonstrated limited and unsustained human-to-human transmission.

MERS-CoV is circulating in the Arabian Peninsula, primarily in Saudi Arabia. Countries in or near the Arabian Peninsula with reported MERS-CoV infections include Iran, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, United Arab Emirates and Yemen.^{Footnote 6} Travel-associated MERS-CoV cases have been reported in Algeria, Austria, China, Egypt, France, Germany, Greece, Italy, Malaysia, Netherlands, Philippines, Republic of Korea, Tunisia, Turkey, United Kingdom and United States of America.^{Footnote 6} The outbreak in the Republic of Korea represents the largest outbreak outside of the endemic region.^{Footnote 3}

2. Biosafety Requirements

The following table summarizes the appropriate physical and operational containment requirements for laboratories working with MERS-CoV. Based on the clinical presentation of severe respiratory illness and the low risk to public health due to limited human-to-human transmission, this novel coronavirus is classified as a Risk Group 3 (RG3) human pathogen requiring Containment Level 3 (CL3 or CL3-Ag) for all in vitro propagative or in vivo activities. Non-propagative diagnostic or clinical activities can be conducted at CL2 with additional biosafety requirements, as specified below.

The Agency will continue to monitor this situation and will update this advisory based on new information, if appropriate. Laboratories should refer to the Canadian Biosafety Standards and Guidelines, First Edition, 2013^{Footnote 7} for a complete listing of the biosafety requirements.

Sample Type and Activity	Minimum Containment Level Required
	CL2	CL3
Non-Propagative Clinical/Diagnostic Activities Examples of these activities include, but are not limited to: processing specimens for packaging and distribution to laboratories; diagnostic testing activities (excluding culture); and molecular testing of nucleic acids.	Note de bas de page *
Propagative in vitro Activities Examples of these activities include, but are not limited to: culture of specimens; preparatory work for in vivo activities; and processing positive cultures for packaging and distribution to laboratories.
In Vivo Work		Note de bas de page +

3. Additional Biosafety Requirements

In addition to the containment requirements listed for CL2 in the CBSG Part I Chapters 3 and 4, the additional requirements below are to be followed for non-propagative clinical/diagnostic activities.

Non-Propagative Clinical/Diagnostic Activities

• All activities involving open vessels of infectious material to be conducted in a certified BSC or other appropriate primary containment device (CBSG R4.6.24).
• Respirators to be worn (CBSG R4.4.8) for activities conducted outside a primary containment device in accordance with the risk of exposure when handling/transporting infectious material/waste.
• An additional layer of protective clothing (e.g., solid-front gown with tight fighting wrists) to be donned prior to work with infectious material in accordance with entry procedures (CBSG R4.4.6).

Personnel to doff additional layer of PPE when exiting the containment barrier (CBSG R4.5.13). Doffed PPE to be kept near the dedicated work area.

4. Transportation

Packaging, shipping and transport of specimens must comply with the requirements of the Transportation of Dangerous Goods Regulations^{Footnote 8}, Transport Canada and the Dangerous Goods Regulations, International Air Transport Association.

• For air shipments, cultures (i.e. propagated virus) should be shipped as Category A, UN2814.
• For air shipments, patient/primary sample specimens should be shipped as Category B, UN3373.

For further information on how to receive training and certification in the Transportation of Dangerous Goods, please contact the Laboratory Safety Office at lsd-dsl@hc-sc.gc.ca or contact on the 24/7 emergency phone line at 613-292-6754.

5. Contact Information

Please note that 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 from the PHAC Centre for Biosecurity, on our website at: Laboratory Biosafety and Biosecurity or at (613) 957-1779, fax (613) 941-0596 and by email: biosafety_biosecurity@phac-aspc.gc.ca.

7. Resources

1. PHAC Information Page on Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
2. WHO Global Alert and Response (GAR) Coronavirus Infections
3. WHO Laboratory Testing for Middle East Respiratory Syndrome Coronavirus - Interim recommendations, September 2013 (PDF Document)
4. CDC Information Page on Middle East Respiratory Syndrome