Pathogen Safety Data Sheets: Infectious Substances – Ebolavirus

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Section I – Infectious Agent

NAME: Ebolavirus
Agent type: Virus
Taxonomy:
Family: Filoviridae
Genus: Ebolavirus
Species: Bundibugyo ebolavirus, Reston ebolavirus, Sudan ebolavirus, Tai Forest ebolavirus, Zaire ebolavirus

Synonym or Cross Reference: Also known as African haemorrhagic fever, Ebola haemorrhagic fever (EHF, Ebola HF, Ebola), Filovirus, EBO virus (EBOV), Zaire ebolavirus (ZEBOV), Sudan ebolavirus (SEBOV, SUDV), Ivory Coast ebolavirus (ICEBOV), Tai Forest ebolavirus (TAFV), Ebola-Reston (REBOV, EBO-R, Reston virus, RESTV), Bundibugyo ebolavirus (BEBOV, BDBV), and Ebola virus disease (EVD)Footnote 1Footnote 2Footnote 3Footnote 4.

Characteristics:

Brief Description: Ebola was discovered in 1976 and is a member of the Filoviridae family (previously part of the Rhabdoviridae family, which was later classified as a family of its own based on genetic structure). Five Ebola species have been identified: Zaire ebolavirus, which was first identified in 1976 and is the most virulent; Sudan ebolavirus; Tai Forest ebolavirus (formerly Ivory Coast ebolavirus); Reston ebolavirus, originating from the Philippines; and Bundibugyo ebolavirus, which is the most recent species, discovered in 2008Footnote 1Footnote 2Footnote 3Footnote 5Footnote 6Footnote 7.

Properties: Ebola is an elongated filamentous virus, which can vary between 800 - 1000 nm in length, and can reach up to 14,000 nm long (due to concatemerization) with a uniform diameter of 80 nmFootnote 2Footnote 5Footnote 8Footnote 9. It contains a helical nucleocapsid (with a central axis), 20 - 30 nm in diameter, and is enveloped by a helical capsid, 40 - 50 nm in diameter, with 5 nm cross-striationsFootnote 2Footnote 5Footnote 8Footnote 9Footnote 10. The pleomorphic viral fragment may take on several distinct shapes (e.g., in the shape of a "6", a "U", or a circle), and are contained within a lipid membraneFootnote 2Footnote 5. Each virion contains a single-strand of non-segmented, negative-sense viral genomic RNAFootnote 5Footnote 11.

Section II – Hazard Identification

Pathogenicity/Toxicity: Ebola virions enter host cells through endocytosis and replication occurs in the cytoplasm. Upon infection, the virus affects the host blood coagulative and immune defense system and leads to severe immunosuppressionFootnote 10Footnote 12. Early signs of infection are non-specific and flu-like, and may include sudden onset of fever, asthenia, diarrhoea, headache, myalgia, arthralgia, vomiting, and abdominal painsFootnote 13Footnote 14. Less common early symptoms include conjunctival injection, sore throat, rashes, and bleeding. Shock, cerebral oedema, coagulation disorders, and secondary bacterial infection may co-occur later in infectionFootnote 8. Haemorrhagic symptoms may begin 4 - 5 days after onset, including hemorrhagic conjunctivitis, pharyngitis, bleeding gums, oral/lip ulceration, hematemesis, melena, hematuria, epistaxis, and vaginal bleedingFootnote 15. Hepatocellular damage, marrow suppression (such as thrombocytopenia and leucopenia), serum transaminase elevation, and proteinuria may also occur. Persons that are terminally ill typically present with obtundation, anuria, shock, tachypnea, normothermia to hypothermia, arthralgia, and ocular diseasesFootnote 16. Haemorrhagic diathesis is often accompanied by hepatic damage and renal failure, central nervous system involvement, and terminal shock with multi-organ failureFootnote 1Footnote 2. Contact with the virus may also result in symptoms such as severe acute viral illness, malaise, and maculopapular rash. Pregnant women will usually abort their foetuses and experience copious bleedingFootnote 2Footnote 17. Fatality rates range between 50 - 100%, with most dying of hypovolemic shock and multisystem organ failureFootnote 18.

Pathogenicity between species of Ebola does not differ greatly in that they have all been associated with hemorrhagic fever outbreaks in humans (excluding Reston ebolavirus) and non-human primates. The Zaire and Sudan strains are especially known for their virulence with up to a 90% fatality rateFootnote 19, with reduced virulence noted in the Tai Forest ebolavirus and the more recently discovered Bundibugyo strain, which caused a single outbreak in UgandaFootnote 6Footnote 7. Bundibugyo was the outbreak virus in Isiro, Democratic Republic of Congo, in 2012. Reston ebolavirus was isolated from cynomolgus monkeys from the Philippines in 1989 and is less pathogenic in non-human primates. Reston ebolavirus appears to be non-pathogenic in humans, with reported health effects limited to serological evidence of exposure as identified in 4 animal handlers working with infected non-human primatesFootnote 20.

The largest outbreak of Ebola virus disease began in Guinea in December 2013 and was caused by the Zaire ebolavirusFootnote 14. This outbreak was marked by gastrointestinal clinical presentation, although the most common symptoms for Ebola virus disease are fever with anorexia, asthenia, and maculopapular rash 5 to 7 days after disease onsetFootnote 14. The case fatality rate during this outbreak is estimated to be around 50%Footnote 14.

Communicability: Communicable as long as blood, body fluids or organs, contain the virus. Ebolavirus has been isolated from semen 61 to 82 days after the onset of illness, and transmission through semen is thought to be possibleFootnote 1Footnote 2Footnote 21Footnote 22.

In an outbreak, it is hypothesized that the first patient becomes infected as a result of contact with an infected animal (23). Person-to-person transmission occurs via close personal contact with an infected individual or their body fluids during the late stages of infection or after deathFootnote 1Footnote 2Footnote 23Footnote 24. Principle routes of infection include inoculation, mucous membranes, and abraded or injured skinFootnote 14. Nosocomial infections can occur through direct contact with infected body fluids, for example due to the reuse of unsterilized syringes, needles, or other medical equipment contaminated with these fluidsFootnote 1Footnote 2. Humans may be infected by handling sick or dead non-human primates and are also at risk when handling the bodies of deceased humans in preparation for funeralsFootnote 2Footnote 10Footnote 25. The index case in the outbreak that originated in Guinea in December 2013 is believed to have resulted from consuming infected bushmeatFootnote 14.

In laboratory settings, non-human primates exposed to aerosolized ebolavirus from pigs have become infected; however, airborne transmission has not been demonstrated between non-human primatesFootnote 1Footnote 10Footnote 16Footnote 26Footnote 27. Viral shedding has been observed in nasopharyngeal secretions and rectal swabs of pigs following experimental inoculationFootnote 28Footnote 29. Intranasal infection studies in guinea pigs suggests that transmission through direct contact with infectious materials, including those transported in aerosols over short distances, is more infectious compared to systemic infectionFootnote 30.

Epidemiology: Occurs mainly in areas surrounding rain forests in equatorial AfricaFootnote 10 with the exception of Reston, which is documented to have originated in the PhilippinesFootnote 7. No predispositions to infection have been identified among infected persons.

The largest recorded ebolavirus outbreak to date began in December 2013, with initial cases reported in Guinea and then additional cases identified in the surrounding regions (Liberia, Sierra Leone, Nigeria). A new strain of the Zaire ebolavirus was identified as the causative agent of the outbreakFootnote 14Footnote 17Footnote 23Footnote 31 and has resulted in more than 10,000 deaths and more than 20,000 suspected, probable, and confirmed casesFootnote 32.

An ebolavirus outbreak began in the Bikoro region, Equateur Province, in the Democratic Republic of the Congo in May 2018 with confirmed cases reaching 38 by the middle of June 2018Footnote 33Footnote 34.

Host Range:

Natural Host(s): Humans, various monkey species, chimpanzees, gorillas, baboons, and duikers are natural animal hosts for ebolavirusFootnote 1Footnote 2Footnote 5Footnote 23Footnote 28Footnote 29Footnote 35Footnote 36Footnote 37Footnote 38Footnote 39Footnote 40Footnote 41. Serological evidence of immunity markers to ebolavirus in serum collected from domesticated dogs suggests asymptomatic infection is plausible, likely following exposure to infected humans or animal carrionFootnote 42Footnote 43. The Ebolavirus genome was discovered in two species of rodents and one species of shrew living in forest border areas, raising the possibility that these animals may be intermediary hostsFootnote 44.

Other Host(s): Experimental studies of the virus have been done using mouse, pig, guinea pig, and hamster models, suggesting wild-type ebolavirus has limited pathogenicity in these modelsFootnote 45Footnote 46.

Infectious Dose: Although ebolavirus aerosol transmission is not considered to be a primary route of infection, viral hemorrhagic fevers have an experimentally determined infectious dose of 1 - 10 organisms by aerosol in non-human primatesFootnote 47. The specific infectious dose for ebolavirus is unknown; however, rhesus monkeys exposed to aerosol in an artificial setting experienced clinical disease with inhaled doses of 2.6 log10 plaque forming units (PFUs) of ebolavirus particles with diameters ranging from 0.8 to 1.2 µmFootnote 48

Incubation Period: Range of 2-21 days, but normally 4-10 daysFootnote 1Footnote 14Footnote 16Footnote 18.

Section III – Dissemination

Reservoir: The natural reservoir of Ebola is unknown, but specific species of bat are considered a possible natural reservoir based on the presence of serum antibodies and viral RNAFootnote 2Footnote 14Footnote 49Footnote 50Footnote 51Footnote 52Footnote 53. Serological evidence of infection with ebolavirus (antibody detection to ebolavirus, including Zaire and/or Reston ebolavirus) has been reported in fruit bats collected from woodland and forested areas near Ghana and Gabon, with reduced frequency of isolation from bats collected in mainland China and BangladeshFootnote 50Footnote 51Footnote 52Footnote 53. Antibodies to the virus have been found in the serum of domestic guinea pigs and wild rodents, with no relation to human transmissionFootnote 44Footnote 54.

Zoonosis/Reverse Zoonosis: Zoonosis between animals and humans is suspectedFootnote 2Footnote 14Footnote 23Footnote 50.

Vectors: Unknown.

Section IV – Stability and Viability

Note: all information available on stability and viability comes from peer-reviewed literature sources depicting experimental findings and is intended to support local risk assessments in a laboratory setting.

Drug Susceptibility: In Canada, there are currently no approved vaccines or therapeutics available for the prevention, post-exposure prophylaxis, or treatment of Ebola virus disease. The symptoms of the disease may be treated by providing intravenous fluids and balancing electrolytes, maintaining oxygen status and blood pressure, replacement of lost blood and clotting factors, and treating other infections if they occurFootnote 55.

Recombinant vesicular stomatitis virus (VSV) based vaccines have demonstrated efficacy in nonhuman primate models as both single preventative vaccines and as post-exposure treatmentsFootnote 56. VSV-EBOV is an experimental vaccine developed in Canada that contains an Ebola virus glycoprotein instead of a VSV glycoprotein. The vaccine has undergone clinical trials in Canada and the United States.

Monoclonal antibodies have also shown great promise as an effective treatment for Ebola virus disease. ZMapp, a cocktail of 3 highly purified monoclonal antibodies, has shown 100% protection of nonhuman primates when treatment is initiated up to 5 days post-exposureFootnote 57. ZMapp has not yet been tested for safety and efficacy in a human clinical trial, although trials for monoclonal antibodies are underwayFootnote 58.

Drug Resistance: There are no known antiviral treatments available for human infections.

Susceptibility to Disinfectants: Ebolavirus is susceptible to 3% acetic acid, 1% glutaraldehyde, alcohol-based products, calcium hypochlorite (bleach powder), and dilutions of 5.25% household bleach (i.e., 0.525% to 0.0525% sodium hypochlorite for ≥ 10 min)Footnote 59Footnote 60Footnote 61Footnote 62. The WHO recommendations for cleaning up spills of blood or body fluids suggest flooding the area with a 1:10 dilution of 5.25% household bleach (i.e., 1 part household bleach diluted in 9 parts water, or 0.525% sodium hypochlorite) for 10 minutes for surfaces that can tolerate stronger bleach solutions (e.g., cement, metal)Footnote 62. For surfaces that may corrode or discolour, they recommend careful cleaning to remove visible stains followed by contact with a 1:100 dilution of 5.25% household bleach (i.e., 1 part household bleach diluted in 99 parts water, or 0.0525% sodium hypochlorite) for more than 10 minutes.

Laboratory tests have demonstrated that the use of 70% ethanol for 1 minute is effective at inactivating Mayinga and Kikwit variants of the virus, whereas 2.5 minutes is required to inactivate the Makona variant. Ethanol concentrations in the 60 to 95% range are suggested by the United States Food and Drug AdministrationFootnote 63. Use of 0.5% and 1% sodium hypochlorite solutions (i.e., 50 mL household bleach into 450 mL or 200mL water, respectively) for 5 minutes is effective at inactivating all three variantsFootnote 63Footnote 64. A 0.5% chlorine solution is also recommended by the WHO to disinfect surfaces contaminated with EbolavirusFootnote 63.

Physical Inactivation: Ebola are moderately thermolabile and can be inactivated by heating for 30 minutes to 60 minutes at 60°C, boiling for 5 minutes, or gamma irradiation (1.2 x106 rads to 1.27 x106 rads) combined with 1% glutaraldehydeFootnote 10Footnote 59Footnote 61. Ebolavirus has also been determined to be moderately sensitive to UVC radiationFootnote 65. Ebolavirus Makona strain virions in spike serum samples can be inactivated after incubation for 1 hour with 0.5% Tween-20 at 56°C, which is considered a more practical application in the fieldFootnote 66. A high Ebola viral load in whole-blood thin-smear samples can be inactivated using a 15 minute 100% methanol fixation stepFootnote 67.

Virus inactivation is recommended for samples intended for clinical laboratory testing. Guanidine thiocyanate-based lysis buffers commonly used during nucleic acid extraction processes (e.g., for downstream PCR applications) may be effective for the inactivation of enveloped RNA virusesFootnote 68Footnote 67Footnote 70. The inactivation method should be selected based on its viral inactivation efficacy, as well as its interference with the subsequent test results (e.g., electrolytes, glucose, enzymes, protein). Please see the Biosafety Guidelines for Clinical Laboratories Handling Specimens from patients Under Investigation for Ebola Virus Disease for more information.

Survival Outside Host: Filoviruses have been reported capable to survive for weeks in blood and can also survive on contaminated surfaces, particularly at low temperatures (4°C)Footnote 71Footnote 72. Under West African climate conditions of 28°C and 90% relative humidity, ebolavirus can persist in dried human or non-human primate blood for 7 to 10 daysFootnote 64. One study could not recover any Ebolavirus from experimentally contaminated surfaces (plastic, metal or glass) at room temperatureFootnote 72. In another study, Ebolavirus dried onto glass, polymeric silicone rubber, or painted aluminum alloy was able to survive in the dark for several hours under ambient conditions (between 20°C and 25°C and 30–40% relative humidity; amount of virus reduced to 37% after 15.4 hours), but was less stable than some other viral hemorrhagic fevers, such as Lassa virusFootnote 65Footnote 73. When dried in tissue culture media onto glass and stored at 4 °C, Zaire ebolavirus survived for over 50 daysFootnote 72. Ebolavirus Makona variant suspended in organic soil has been shown to persist on steel and plastic surfaces for up to 192 hours compared to less than 24 hours on cotton. Ebolavirus suspended in serum can persist in the environment for up to 46 daysFootnote 63. This information is based on experimental findings only and not based on observations in nature. This information is intended to be used to support local risk assessments in a laboratory setting.

In average West African climatic conditions of 27°C and 80% relative humidity, ebolavirus (Makona variant strain) can remain viable on gloves (<1 hour), cotton and goggles (<24 hours), and other PPE such as respirators, suits and hoods (<72 hours)Footnote 74.  

A study on transmission of ebolavirus from fomites in an isolation ward concludes that the risk of transmission is low when recommended infection control guidelines for viral hemorrhagic fevers are followedFootnote 75. These infection control protocols included decontamination of floors with 0.5% bleach daily and decontamination of visibly contaminated surfaces with 0.05% bleach as necessary.

Section V – First Aid / Medical

Surveillance: Definitive diagnosis can be reached rapidly in an appropriately equipped laboratory using a multitude of approaches, including RT-PCR to detect viral RNA, ELISA based techniques to detect anti-Ebola antibodies or viral antigens, immunoelectron microscopy to detect ebolavirus particles in tissues and cells, and indirect immunofluorescence to detect antiviral antibodiesFootnote 1Footnote 2Footnote 15Footnote 47. It is useful to note that Marburgvirus is morphologically indistinguishable from the ebolavirus, and laboratory surveillance of Ebola is extremely hazardousFootnote 1Footnote 2Footnote 15Footnote 76. Please see the Biosafety Guidelines for Clinical Laboratories Handling Specimens from patients Under Investigation for Ebola Virus Disease for more information.

Note: All diagnostic methods are not necessarily available in all countries.

Note: The specific recommendations for surveillance in the laboratory should come from the medical surveillance program, which is based on a local risk assessment of the pathogens and activities being undertaken, as well as an overarching risk assessment of the biosafety program as a whole. More information on medical surveillance is available in the Canadian Biosafety Handbook (CBH).

First Aid/Treatment: There is no effective antiviral treatmentFootnote 39Footnote 50. Although favipiravir can rescue animals following a lethal dose of Ebola virus, antiviral activity against Ebola virus is considered relatively weak and there is no efficacy data availableFootnote 77. Instead, treatment is supportive and may include providing intravenous fluids and balancing electrolytes, maintaining oxygen status and blood pressure, replacement of lost blood and clotting factors, and treating other infections if they occur for maintenance of organ function, and combating haemorrhage and shockFootnote 23Footnote 55Footnote 78. In Canada, there are currently no approved vaccines or therapeutics available for the prevention, post-exposure prophylaxis, or treatment of Ebola virus disease. Monoclonal antibodies are also under investigation for treatment for Ebola virus disease, but have not been approved for useFootnote 77. A Phase 1 clinical trial evaluating the safety and tolerability of a single monoclonal antibody (mAb114) developed from an Ebola survivor is underway (58). Convalescent blood products from survivors of Ebola virus disease have been administered to patients in Africa, but the benefits of such a treatment remain unclearFootnote 77.

Note: The specific recommendations for first aid/treatment in the laboratory should come from the post-exposure response plan, which should be developed as part of the medical surveillance program. More information on the post-exposure response plan can be found in the CBH.

Immunization: There are currently no licensed vaccines available for preventing Ebola virus disease; however, candidate vaccine rVSV-ZEBOV has been studied in phase 1 and 2 clinical trials where it demonstrated dose-related reactogenicity and immunogenicity, as well as a phase 3 clinical trial in West Africa using a ring vaccination cluster-randomised design. The results of these trials suggest that rVSV-ZEBOV is safe and effective as a pre-exposure prophylaxis for Zaire ebolavirusFootnote 77Footnote 79. Since the vaccine is considered experimental, it has been administered on the grounds of compassionate use in the 2018 Ebolavirus outbreak in the Democratic Republic of the CongoFootnote 80. For more information on rVSV-ZEBOV, please consult the VSV-EBOV – Canada’s vaccine for Ebola Fact Sheet.

Other potential vaccine candidates moving towards clinical trials include human adenovirus serotype 26 or 35 platforms with a Modified vaccinia Ankara (MVA) boost. Vaccine efficacy has been studied in Guinea pigs mucosally-infected with Ebolavirus, as this is a more common infection route compared to intramuscular infection in non-human primate models. Guinea pigs infected intranasally showed 100% survival with prior administration of adjuvanted Ad5-ZGPFootnote 81.

Note: More information on the medical surveillance program can be found in the CBH, and by consulting the Canadian Immunization Guide.

Prophylaxis: None. Management of the Ebola virus is solely based on isolation and barrier-nursing with symptomatic and supportive treatmentsFootnote 8. Candidate vaccine rVSV-ZEBOV has been used as post-exposure prophylaxis in humans; however, findings suggest that immunity is insufficiently rapid to reliably prevent Ebola virus disease in human beings when administered following exposureFootnote 77.  

Note: More information on prophylaxis as part of the medical surveillance program can be found in the CBH.

Section VI - Laboratory Hazards

Laboratory-Acquired Infections: One reported near-fatal case following a minute finger prick in an English laboratory (1976)Footnote 76. A Swiss zoologist contracted Ebola virus after performing an autopsy on a chimpanzee in 1994Footnote 2Footnote 82. An incident occurred in Germany in 2009 when a laboratory scientist pricked herself with a needle that had just been used on a mouse infected with Ebola; however, human infection was not confirmed. Additional incidents were recorded in the US in 2004 and a fatal case in Russia in 2004Footnote 8.

Note: Please consult the Canadian Biosafety Standard (CBS) and CBH for additional details on requirements and guidelines for reporting exposure incidents.

Sources/Specimens: Blood, vomit, serum, urine, respiratory and throat secretions, semen, and organs or their homogenates from human or animal hostsFootnote 1Footnote 2Footnote 73. Human or animal hosts, including non-human primates, may represent a further source of infectionFootnote 76.

Primary Hazards: Accidental parenteral inoculation, respiratory exposure to infectious aerosols/droplets, and/or direct contact with skin or mucous membranesFootnote 76.

Special Hazards: Work with, or exposure to, infected non-human primates, rodents, or their carcasses represents a risk of human infectionFootnote 76.

Section VII - Exposure Controls / Personal Protection

Risk Group Classification: All members of the genus Ebolavirus are considered to be a Risk Group 4 (RG4) human pathogen and RG4 animal pathogen. Ebolavirus is also a security sensitive biological agent (SSBA)Footnote 83.

Containment Requirements: The applicable Containment Level 4 (CL4) requirements specified in the CBS and in the Biosafety Guidelines for Laboratories Handling Specimens from Patients Under Investigation for Ebola Virus Disease are to be followed.

Note: There are additional security requirements, such as obtaining a Human Pathogens and Toxins Act Security Clearance, for work involving SSBAs.

Protective Clothing: In laboratories where specimens from patients under investigation for Ebola virus are handled: Personnel entering the laboratory should remove street clothing, including undergarments, and jewellery, and change into dedicated laboratory clothing and shoes, or don full coverage protective clothing (i.e., completely covering all street clothing). Additional protection may be worn over laboratory clothing when infectious materials are directly handled, such as solid-front gowns with tight fitting wrists, two pairs of gloves , and an approved particulate respirator (e.g., N95 or higher). Eye protection should be used where there is a known or potential risk of exposure to splashes (e.g., goggles, face shields). Impermeable cleanable footwear, or fluid-resistant or impermeable boot/shoe covers should be worn. Removal of PPE should be done in a manner that minimizes contact with the skin, hair, face, and solid items. Contaminated clothing and PPE should be appropriately decontaminated.

In CL4 laboratories: Personnel entering the laboratory must remove street clothing, including undergarments, and jewellery, and change into dedicated laboratory clothing and shoes.  Personnel must don a positive pressure suit or wear additional protection over laboratory clothing, such as solid-front gowns with tight fitting wrists, two pairs of gloves, and an approved particulate respirator (e.g., N95 or higher) for work within a class III biological safety cabinet (BSC) line. Impermeable cleanable footwear, or fluid-resistant or impermeable boot/shoe covers must be worn. Removal of PPE to be done in a manner that minimizes contact with the skin, hair, face, and solid items. Contaminated clothing and PPE to be appropriately decontaminated.

Other Precautions: In CL4 laboratories: All activities with infectious material must be conducted in a BSC in combination with a positive pressure suit, or within a class III BSC line. Centrifugation of infected materials must be carried out in closed containers placed in sealed safety cups, or in rotors that are unloaded in a biological safety cabinet. The integrity of positive pressure suits must be routinely checked for leaks. The use of needles, syringes, and other sharp objects to be strictly limited. Open wounds, cuts, scratches, and grazes to be covered with waterproof dressings. Minimize activities that may generate aerosols (e.g., mixing samples, by pipetting, centrifugation). Additional precautions to be considered with work involving animal activities.

In laboratories where specimens from patients under investigation for Ebola virus are handled: All activities with infectious material should be conducted in a BSC.  Centrifugation of infected materials to be carried out in closed containers placed in sealed safety cups, or in rotors that are unloaded in a BSC. Only thin blood smears should be prepared. Blood cultures should be prepared in a closed system and sub-culturing should only be performed if it is essential to patient care as it has the potential to generate aerosols.

Dipstick tests for patients that are under investigation should only be performed on inactivated blood. If ports or vents are present on automated analyzers that may allow for the release of aerosols into the laboratory area, it is recommended that the system be contained, in a certified BSC; within a plexiglass or flexible film cover; or through use of HEPA filters for air exhausted from the system.

Laboratories should maintain records of all individuals who have handled, decontaminated and transported these types of clinical specimens. It may be useful to establish “chain of custody” procedures to enhance biosecurity in the management and transfer of specimens from patients under investigation for EVD.

Within hospitals, it is not recommended to use any pneumatic tube transport system/capsule pipelines for transporting suspected EVD specimensFootnote 84. Specimen containers to be transported for additional/confirmatory testing are to be surface decontaminated using an effective disinfectant prior to packaging. If transportation delays are expected, samples should be stored in a refrigerator, or frozen at -70° in a secure area.

For shipping samples between facilities or to the National Microbiology Laboratory (NML) liaise with the provincial public health laboratory of your jurisdiction to coordinate with the NML Operations Center Director (OCD) at 1-866-262-8433. For shipments, patient/primary sample specimens should be shipped as “UN2814, Category 6.2”, and Emergency Response Assistance Plan (ERAP) must be activated.

Section VIII - Handling and Storage

Spills: In laboratories handling specimens from patients under investigation for Ebola virus:   Allow aerosols to settle. Wearing protective clothing, gently cover the spill with absorbent paper towel and apply suitable disinfectant, starting at the perimeter and working towards the centre. Allow sufficient contact time before clean-upFootnote 85.

The spill area should be evacuated and secured. Aerosols should be allowed to settle for a minimum of 30 minutes. Spills of potentially contaminated material should be covered with absorbent paper-based material (e.g., paper towels), liberally covered with an effective disinfectant (e.g., 1% sodium hypochlorite), and left to soak for an appropriate amount of time (e.g., 10 minutes) before being wiped up. Following the removal of the initial material, the disinfection process should be repeated. Individuals performing this task should wear PPE, including particulate respirators (e.g., N95 or higher). Disposable gloves, impermeable gowns and protective eye wear are to be removed immediately after completion of the process, placed in an autoclave bag, and decontaminated prior to disposal.

Disposal: All materials/substances that have come in contact with the infectious agent should be completely decontaminated before they are removed from the containment zone.  This can be achieved by using a decontamination method that has been demonstrated to be effective against the infectious material, such as chemical disinfectants, autoclaving, irradiation, incineration, an effluent treatment system, or gaseous decontaminationFootnote 85.

Storage: The applicable CL4 or CL4-Ag requirements for storage outlined in the CBS should be followed. All infectious material should be stored in the containment zone.

Section IX – Regulatory and Other Information

Regulatory Information: The import, transport, and use of pathogens in Canada is regulated under many regulatory bodies, including the Public Health Agency of Canada, Health Canada, Canadian Food Inspection Agency, Environment Canada, and Transport Canada. Users are responsible for ensuring they are compliant with all relevant acts, regulations, guidelines, and standards.

Work with Ebolavirus requires a Human Pathogens and Toxins Licence, issued by the Public Health Agency of Canada, and a Health of Animals Act import permit, issued by the Canadian Food Inspection Agency.

Ebolavirus is under official control for the following: Select Agent and Toxin (United States), Security Sensitive Biological Agent, Nationally Notifiable Disease (Viral Hemorrhagic Fever) and Quarantine Act. Ebolavirus also has Emerging Animal Disease (EAD) status (please contact the Canadian Food Inspection Agency).

Updated: 2018

Prepared by: Centre for Biosecurity, Public Health Agency of Canada.

Although the information, opinions, and recommendations contained in this Pathogen Safety Data Sheet are compiled from sources believed to be reliable, the PHAC accepts no responsibility for the accuracy, sufficiency, or reliability or for any loss or injury resulting from the use of the information. Newly discovered hazards are frequent and this information may not be completely up to date.

Copyright ©
Public Health Agency of Canada, 2018
Canada

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