Diagnostic Testing: 
Ebola Information for Health Professionals

11/03/2014

• If evaluating a patient suspected to have Ebola virus disease, call the Minnesota Department of Health at 651-201-5414.
• Follow Ebola Recommended Infection Control Measures for health care workers when involved in direct patient care.

On this page:
About testing at MDH
Process for submitting to MDH
Test results and confirmation 
PPE for routine laboratory tests 
Managing laboratory and medical waste
Additional laboratory tests 
More information
 

About testing at MDH

• The Minnesota Department of Health Public Health Laboratory (MDH-PHL) will provide Ebola virus testing 24/7 after consultation with MDH Epidemiologists at 651-201-5414.
• MDH-PHL utilizes the FDA Emergency Use Authorization Ebola Zaire Polymerase Chain Reaction assay to detect Ebola Zaire. It does not detect any other viral hemorrhagic fever (VHF) viruses (i.e. Lassa fever, Ebola Reston, etc.).
• Performance characteristics and limits of detection data can be found in the product insert.
   
• MDH-PHL will submit specimen to CDC for additional testing for VHF viruses.
• MDH-PHL passed the proficiency testing panel and was ready to perform testing on September 1, 2014.
• MDH-PHL does not perform viral culture for Ebola.

Process for submitting to MDH

• Consultation: Contact MDH Epidemiologists at 651-201-5414 to determine if testing is warranted and to discuss specimen submission and logistics.
  
   
• Collection: Collect two (2) 4-mL purple top plastic EDTA tubes, labeled with patient name/ID#, date of birth, and collection date.
  • One tube is for testing performed at MDH-PHL.
  • The 2nd tube will be sent to CDC for additional testing for other VHF viruses.
• Form: Infectious Disease Laboratory - Forms 
  Use the Infectious Disease Testing and Submission Form.
  
   
• Packaging: Samples can be packaged as DOT Category A.
  • Ship samples as “Suspect Category A Infectious Substance”.
  • CDC has stated that Category B is adequate, but MDH-PHL recommends Category A.
  • Ultimately the packaging designation is up to the shipper.
  • Federal Register: Department of Transportation: Pipeline and Hazardous Materials Safety Administration (PDF)
    Laboratories are required to comply with DOT regulations when shipping by ground and IATA regulations when shipping by air. Personnel must be certified by their institution in packaging and shipping. Attn: Non-MDH link.
  • FedEx will ship a potential Ebola specimen with the technical name of “suspected category A infectious substance”.
• Transportation: Specimen transport will be discussed during consultation with MDH.
  • MDH will assist submitting laboratories with transportation.
  • Ultimately, the goal is to expedite the shipment of these specimens.  MDH has identified multiple options for sample delivery dependent on location, time of day, resource availability and transport time.
  • The following are transport options that will be discussed during the consultation: Routine courier, MDH Stat courier, FedEx, MDH employee, State Patrol
  • Any courier that normally transports Category A samples can transport to MDH for diagnostic testing to rule in or rule out Ebola. No additional training is required.
• CDC Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States

Select Agent Regulations regarding Ebola

• Specimens collected from a patient suspected to have Ebola infection are not considered to be select agents and do not fall under Federal Select Agent Regulation unless and until identification is confirmed by viral culture.
• Viral Culture confirmed Ebola virus is considered a Category A UN2814 hazardous material risk group 4 and falls under the Select Agent regulations as a Tier 1 agent.
• Interim Guidance Regarding Compliance with Select Agent Regulations for Laboratories Handling Patient Specimens that are Known or Suspected to Contain Ebola Virus 
  More information regarding the Select Agent Program’s guidance on Ebola. Test results and confirmation
  
   
• The estimated turnaround time for presumptive results is 4- 6 hours upon receipt of sample for a single specimen and may be longer for multiple specimens.
• All specimens tested at MDH-PHL will also be forwarded to CDC for more extensive laboratory testing.

PPE for personnel performing routine laboratory tests

• CDC’s guidance for the use of PPE in the laboratory has not been modified.
• MDH recommends that each laboratory performs a risk assessment of their procedures to determine the proper PPE for their laboratory staff.
• PPE is essential to mitigate the risk of exposure for your laboratory staff.
• Follow Ebola Recommended Infection Control Measures when involved in direct patient care.

Managing laboratory and medical waste

• All waste from a suspect Ebola patient should be separated until test results confirm diagnosis.
  • If Ebola is not present, waste can be discarded as routine biohazardous waste.
  • If the patient is confirmed to have Ebola, then waste must be disposed of according to Category A waste regulations.
• The best way to manage waste generated from a patient with Ebola is via autoclave.
  • Once the waste has been autoclaved, it is no longer infectious waste and not category A waste, thus it can be disposed of in your routine biohazard waste stream.
  • If you are unable to autoclave your waste, you must package it according to DOT Category A regulations before waste can be transported.
  • It is important to work with your facility and your waste management provider to make sure this issue is being addressed.

Additional laboratory tests to perform on a possible Ebola patient

• We are unable to give laboratories and exact list of supportive tests that can be done safely on your routine laboratory equipment.
  • Each Ebola patient will have different needs and each facility is unique.
  • Each laboratory must work within their facility with administration, infection prevention, and safety staff to perform a risk assessment for your facility.
• Malaria testing: 
  MDH has malaria PCR testing capability.
  • Turnaround time is 6-24 hours depending on time of day we received the sample.
  • MDH plans to work with each facility during the consultation to determine if testing is needed.

More information

• MLS Lab Alerts - Minnesota Dept. of Health
  MLS Laboratory Alerts provide information for Minnesota laboratorians about testing for Ebola and more.