October 15, 2014
To:
From:
Subject:
Ohio Clinical Laboratories and Local Health Jurisdictions
Tammy Bannerman, Ph.D., Laboratory Director
Mary Diorio, M.D., M.P.H., Interim Chief, Division of Prevention and Health Promotion
Ebola Virus Disease Laboratory Testing
New Information: Ebola virus disease (EVD) testing is now available at the Ohio Department of Health
Laboratory (ODHL). The test is a real-time Reverse Transcriptase PCR (rRT-PCR) test developed by the
Department of Defense (DoD) and distributed through the Centers for Disease Control and Prevention (CDC)
Laboratory Response Network (LRN). This assay is for use under a U.S. Food and Drug Administration (FDA)
Emergency Use Authorization (EUA) and should only be performed on individuals with signs and symptoms of
Ebola virus infection. Information about this EUA, including the letter of authorization from the FDA to the
DoD outlining the conditions of the authorization may be found on the FDA website:
http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm.
Public information about Ebola virus disease, including case definition and information for healthcare
providers, health departments and laboratories, can be found at http://www.odh.ohio.gov/ and
http://www.cdc.gov/vhf/ebola/hcp/index.html.
When to Collect Specimens for EVD Testing: A consultation with the Ohio Department of Health, Bureau of
Infectious Diseases, Outbreak Response and Bioterrorism Investigation Team (ORBIT) and the CDC is required
prior to test submission. To initiate a consultation call, contact your local health jurisdiction or ORBIT
(614/722-7221). To minimize risk associated with specimen collection and transport, it is recommended that
the consultation occur prior to performance of these activities. The CDC will advise as to whether there is an
indication to perform rRT-PCR testing.
Ebola virus is detected in blood only after the onset of symptoms. Detectable levels of virus may take from 3
to 10 days after symptoms appear. Ideally, specimens should be collected when a symptomatic patient
reports to a healthcare facility and is suspected of having an Ebola virus exposure. However, if the onset of
symptoms is <3 days, a later specimen may be requested to completely rule-out Ebola virus if the first
specimen tests negative.
Specimen Requirements: Two (2) tubes of whole blood preserved with EDTA (plastic purple top) with a
minimum volume of 4 ml each should be submitted. Whole blood preserved with EDTA is preferred but whole
blood preserved with sodium polyanethol sulfonate (SPS), citrate, or with clot activator is acceptable. It is not
necessary to separate and remove serum or plasma from the primary collection container. Do not submit
specimens for EVD testing in glass containers or in heparinized tubes.
Specimens should be immediately stored at 2-8°C.
HEA 6413 (Rev. 8/14)
An Equal Opportunity Employer/Provider
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Specimen Collection: Personnel collecting samples are advised to adhere strictly to facility safety procedures
for the prevention of transmission of bloodborne pathogens (www.cdc.gov/vhf/ebola/hcp/interim-guidancespecimen-collection-submission-patients-suspected-infection-ebola.html). Personal protective equipment
includes the use of full face protection (mask and goggles or face shield), gloves, and an impermeable gown.
Packaging and Shipping: The following steps should be followed when submitting specimens for EVD testing
to the ODHL:
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Complete the ODHL Microbiology Submission form, Form HEA 2530 (ODH Lab Rev 3/2013); a fillable form is
located at: http://www.odh.ohio.gov/pdf/IDCM/sect4TOC.pdf.
Enter Ebola Virus in the Agent Suspected section and fill-in the bubble for Whole Blood in the Specimen
Type & Site Section.
Ship to ODHL at 2-8°C on cold packs.
Specimens for shipment should be packaged following the basic triple packaging system which consists of a
water-tight primary container wrapped with absorbent material (suggest placing specimen tube into a
sealable plastic specimen bag), secondary container (watertight, leak-proof), and an outer shipping package.
(http://www.cdc.gov/vhf/ebola/hcp/packaging-diagram.html). Do not place the submission form in the
same pouch as the specimen; place submission form in a separate sealable plastic bag and place within the
shipping box but outside of the secondary packaging (see List of Contents arrow in diagram).
Email tracking number to ODHLabs@odh.ohio.gov.
Do not ship for weekend delivery unless instructed by ODH.
Ship to:
Ohio Department of Health Laboratory
ATTN Microbiology Lab
8995 East Main Street, Building 22
Reynoldsburg, Ohio 43068
Phone 888-ODH-LABS
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