Ebola Virus Testing at the Maryland Department of Health (MDH) Laboratory
General Background
Ebola Virus Disease (EVD) is a rare and deadly disease most commonly affecting people and nonhuman primates (monkeys, gorillas, and chimpanzees) and it is caused by an infection with a group of Filoviruses within the genus Ebolavirus. These viruses are endemic in certain wild animal populations in regions of western and central Africa and occasionally are responsible for outbreaks of EVD in humans that are initiated from handling wild animals or carcasses that may be infected with Ebola virus (primates, fruit bats, duikers). Ebolavirus can then be further transmitted by blood or bodily fluids of acutely ill persons with suspected or confirmed Ebola virus disease, such as providing care in a home or healthcare setting, participation in corpse contact funeral rituals, working in a laboratory where human specimens are handled and sexual transmission. In an effort to promptly identify returning travelers and others who might have contracted EVD the CDC has provided a standardized Ebola virus real-time PCR assay to state public health laboratories. For additional information on EVD including the current CDC Ebola case definition for recently returning travelers to regions where recent EVD cases have been documented visit the CDC website at: https://www.cdc.gov/vhf/ebola/
The signs and symptoms associated with EVD are non-specific and are similar to many other common causes of febrile illness in returning travelers. Therefore, in addition to Ebolavirus specific testing other conditions such as malaria and viral respiratory illnesses will need to be conducted to help establish the etiology of the illness. For more information visit the CDC Traveler Health website at: https://wwwnc.cdc.gov/travel/diseases/ebola
What testing can the MDH Laboratories Perform?
The Maryland Department of Health (MDH) Laboratory has the capability to perform Ebola Virus Disease testing using a CDC developed real-time PCR assay under an FDA Emergency Use Authorization (EUA). The MDH Laboratory has the capability of testing for two different proteins of the Ebola virus (species Zaire ebolavirus). For more details of the performance characteristics of this assay refer to the EVD interpretive guidelines below. The MDH laboratory can also run other test tests in parallel for a variety of other pathogens that have similar clinical presentations such as malaria and influenza virus.
When can the MDH Laboratories Conduct Ebola Virus Testing
Ebola virus testing can only be conducted with prior authorization from MDH physician-epidemiologists and is restricted to patients who meet the current CDC case definition (CDC link; https://www.cdc.gov/vhf/ebola/clinicians/evaluating-patients/case-definition.html)
Do not collect and submit specimens for Ebola virus testing until an infectious disease consultation with the MDH physician-epidemiologist has been conducted and approval has been obtained to provide testing for the case.
What steps to take if you suspect an Ebola virus infection
To request Ebola Virus testing for a suspect case of Ebola virus infection, contact the MDH Infectious Disease Bureau at 410-767-6700 during business hours and after hours call the MDH Emergency Call Center at 410-795-7365 to arrange the initial infectious disease consultation.
After the consultation, if Ebola virus testing is indicated and authorized, the MDH Laboratory will contact you or your institution’s laboratory to make any additional logistical arrangements needed for expedited testing.
Specimen Collection & Storage
The MDH Laboratories requires at least one of the following Blood specimens:
· Whole Blood
· Serum
· Plasma
Whole blood can be stored up to 7 days at 2-8oC. If a delay in testing is expected, then serum and plasma should be frozen at ≤-70oC.
Additional specimen types may be required to rule out or rule in other etiological agents of febrile illnesses such as influenza or malaria. The MDH Laboratory will provide further guidance on the specimen types needed for additional testing at the time EVD testing is requested.
CDC Guidance for Collection, Transport and Submission of Specimens for Ebola Virus Testing
https://www.cdc.gov/vhf/ebola/laboratory-personnel/specimens.html
Completing the Test Request Form
The MDH Laboratories Administration Form # 4676 Infectious Agents: Culture / Detection must be completed and submitted with each specimen. Click on the links below for an example of the completed form #4676 and the electronic fillable form.
Requisition Sample Completed Form
Electronic Fillable Lab Requisition
Packaging and Shipping
Specimens must be packaged in a triple packaging system to ensure that under normal conditions of transport they cannot break, be punctured or leak their contents (Refer to page 10 in the Lab Services Guide),
Packaging and Shipping Guide (Pages 9 to 11)
Contact Information
To request Ebola virus testing for a suspect case of Ebola virus disease, contact the MDH Infectious Disease Bureau at 410-767-6700 during business hours and after hours call the MDH Emergency Call Center at 410-795-7365 to arrange the initial infectious disease consultation.
For questions or concerns, please contact the Division of Molecular Biology Laboratory at 443-681-3924 or 443-681-3800 during normal business hours from 8:00AM-4:30PM.
Ebola Virus Disease Interpretative Guidelines
Fact Sheet for Health Care Providers: Interpreting CDC Ebola Virus NP Real-Time RT-PCR (EBOV NP rRT-PCR) Assay Results
Fact Sheet for Patients: Understanding Results from the CDC Ebola Virus NP Real-Time RT-PCR (EBOV np rRT-PCR) Assay
Fact Sheet for Health Care Providers: Interpreting CDC Ebola Virus VP40 Real-Time RT-PCR (EBOV VP40 rRT-PCR) Assay Results
Fact Sheet for Patients: Understanding Results from the CDC Ebola Virus VP40 Real-Time RT-PCR (EBOV VP40 rRT-PCR) Assay