Guidance for Collection, Transport and Submission of Specimens for Ebola Virus Testing
Updated: April 1, 2022
- Key Points
- Collecting Specimens for Testing
- Storing Specimens for Testing
- Diagnostic Testing for Ebola
To provide guidance for laboratory workers on collecting, transporting and submitting specimens for Ebola virus testing.
This guidance document replaces the previously posted document: “Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation (PUIs) for Ebola Virus Disease (EVD) in the United States.”
This document complements the updated CDC “Guidance for U.S. Laboratories for Managing and Testing Routine Clinical Specimens When There is a Concern About Ebola Virus Disease” that provides guidance for clinical laboratories on testing needed for assessment and care of patients for whom Ebola Virus Disease (EVD) may be a concern, while minimizing risk to laboratory personnel.
This guidance is based on input received from numerous hospital and laboratory directors, infectious disease physicians, CDC Ebola response teams, and state health officials.
- CDC recommends that Ebola testing be conducted only for persons who meet the criteria for persons under investigation (PUIs) for EVD. A PUI is a person who has both consistent signs and/or symptoms, including:
- Elevated body temperature or subjective fever or symptoms, including severe headache, fatigue, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage, AND
- An epidemiological risk factor within the 21 days preceding the onset of symptoms.
- U.S. hospitals or clinical laboratories concerned about a patient with potential Ebola virus exposure should contact their local and/or state public health authorities. These agencies will work with CDC to determine whether a patient is or is not a PUI, and whether testing is indicated. Patient status should be determined as quickly as possible in order to ensure that patient care is not compromised.
- Presumptive testing for Ebola virus is available at over 60 LRN laboratories located throughout the United States. Any presumptive positive Ebola test result must be confirmed at the CDC to inform public health decisions.
- If it is determined that testing for Ebola virus is indicated, at least 4 mL of whole blood collected in a plastic tube preserved with EDTA is the preferred sample for testing. Specimens should be shipped on dry ice to the designated LRN laboratory.
- If the PUI’s symptoms have been present for <3 days, a second sample collected 72 hours after onset of symptoms is required to definitively rule out Ebola.
- To minimize risk to personnel, a site-specific risk assessment must be performed by the laboratory director, safety officer, and other responsible persons prior to receiving specimens to determine the potential for exposure from sprays, splashes, or aerosols generated during all laboratory processes, procedures, and activities. Risks should be mitigated by implementing engineering controls, administrative and work practice controls, and use of appropriate personal protective equipment (PPE).
- Ebola virus is classified as a Category A infectious substance by the Department of Transportation (DOT) and transport of samples from PUIs or patients confirmed of having EVD is regulated by DOT’s Hazardous Materials Regulations (HMR) 49 CFR 171-180external icon. Specimens for shipment should be packaged following the basic triple packaging system consisting of (1) a primary container (a sealable specimen container) wrapped with absorbent material, (2) a secondary container (watertight, leak-proof), and (3) an outer shipping package.
- The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030)external icon was developed to reduce the potential exposure of personnel to bloodborne pathogens. All U.S. laboratories handling patient specimens are required to comply with this standard at all times. Strict adherence is an initial step in providing protection to personnel.
Ebola virus can cause a severe, often fatal disease in humans and nonhuman primates. It is transmitted through contact with infected blood or body fluids (e.g., urine, stool, and vomit) and with objects such as needles that have been contaminated with infected body fluids. The incubation period is usually 8–10 days (ranging from 2 to 21 days). Patients can transmit Ebola virus once symptoms appear and through the later stages of disease, as well as postmortem. PUIs should be managed by following appropriate precautions to prevent transmission of Ebola virus to others and the hospital environment. For guidance on infection control, see CDC infection control guidance.
Diagnosing EVD in a person who has been infected for only a few days may be complicated. The early symptoms of Ebola virus infection are difficult to distinguish from other, more common infectious diseases such as malaria, influenza, and typhoid fever. Ebola virus is detected in blood only after onset of symptoms, most notably fever, which accompany the rise in circulating virus. However, it may take up to 3 days after symptoms begin for the virus to reach detectable levels.
CDC recommends that Ebola testing be conducted only for persons who meet the criteria for persons under investigation (PUIs) for Ebola virus disease. Presumptive Ebola testing is available at over 60 LRN laboratories and confirmatory Ebola testing is available at the CDC. The decision to test for Ebola should be made with consultation with public health officials. U.S. hospitals or clinical laboratories concerned about a patient with potential Ebola virus exposure should contact their local and state public health authorities before contacting CDC. In joint consultation with CDC (770-488-7100), these agencies will assist in determining whether testing is indicated. No specimens will be accepted by CDC laboratories without prior consultation with CDC.
- Specimens should be obtained when a patient meets the criteria for person under investigation (PUI) including patients with clinical signs, symptoms, and epidemiologic risk factors for Ebola virus disease. If the first specimen is obtained 1-3 days after the onset of symptoms and tests negative and the patient remains symptomatic without another diagnosis, a later specimen is needed to rule-out Ebola virus infection.
- Staff who collect specimens from PUIs should wear appropriate PPE and should refer to Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing).
- For adults, a minimum volume of 4 mL whole blood is preferable. For pediatric samples, a minimum of 1 mL whole blood should be collected in pediatric-sized collection tubes. Blood must be collected in plastic collection tubes. Do not transport or ship specimens in glass containers or in heparinized tubes.
- Do not separate and remove serum or plasma from the primary collection container.
- Specimens should be packaged and transported on dry ice to the final testing destination.
- Call the Emergency Operations Center at 770-488-7100 for a clinical consultation.
If necessary, specimens can be kept at 4°C or frozen for short-term storage of 7 days or less before shipping.
Real-time RT-PCR testing for Ebola virus is available at over 60 LRN laboratories located throughout the United States. LRN laboratories are currently using an FDA-approved Emergency Use Only (EUA) assay to detect the Ebola (Zaire species) virus. Samples that test positive using this assay are considered presumptive positive for Ebola Zaire RNA by real-time RT-PCR and should be submitted to CDC for additional evaluation.
- PPE to be worn during transport within the facility should be determined by a site-specific risk assessment, and may vary among facilities. Recommendations for PPE include disposable fluid-resistant closed lab coat, disposable gloves, covered legs and closed-toed shoes.
- Before removing patient specimens from the site of care, it is advisable to plan the route of the sample from the patient area to the location where it will be packed for shipping to avoid high traffic areas.
- Before removing patient specimens from the site of care, the outside of the specimen containers should be decontaminated with an approved disinfectant as described in Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus.
Note: Recommended disinfectants are those known to kill non-enveloped viruses and can be found in List L of EPA's Disinfectants for Use Against the Ebola Virusexternal icon. This list of registered disinfectants meets the CDC’s criteria for use against the Ebola virus on hard, non-porous surfaces.
- In compliance with OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030external icon), specimens should be placed in a durable, leak-proof secondary container.
- After placing in a secondary container, specimens should be hand-carried to the laboratory or packing area. DO NOT use any pneumatic tube system (automated or vacuum specimen delivery system) for transporting specimens.
- Samples from patients who are PUIs or confirmed to have Ebola virus infection should be packaged and shipped as Category A infectious substances in accordance with the DOT’s Hazardous Materials Regulations (HMR) 49 CFR 171-180external icon.
- All persons packing and shipping infectious substances must be trained and certified in compliance with DOT or the International Air Transport Associationexternal icon (IATA) requirements every two years.
- Specimens collected for Ebola virus testing should be packed and shipped without attempting to open collection tubes or aliquot specimens. Opening the tubes destroys the vacuum seal and thus increases the risk of leakage during transport.
- Specimens for shipment should be packaged following the basic triple packaging system, which consists of (1) a primary container (a sealable specimen container) wrapped with absorbent material, (2) a secondary container (watertight, leak-proof), and (3) an outer shipping package. For questions about (packaging) transportation regulations, contact the U.S. DOT Hazardous Materials Information Center at 1-800-467-4922.
The following steps should be followed by persons certified to ship infectious substances.
- No specimens will be accepted at CDC without prior consultation. For consultation, state or local health departments can call CDC’s Emergency Operations Center at 770-488-7100.
- If testing at CDC is approved, email tracking number to firstname.lastname@example.org
- Package in accordance with the International Air Transport Association (I.A.T.A.)external icon regulations to prevent leakage.
- Ship to:
<Insert CDC Point of Contact>
Centers for Disease Control and Prevention
RDSB/STAT Unit 70
1600 Clifton Road, NE
Atlanta, GA 30329
- Specify specimen storage requirement (frozen) on the outside of the box. Label sample as diagnostic specimen and include the following information:
- Your name
- Patient’s name
- Test(s) requested
- Date of collection
- Laboratory or accession number
- Type of specimen being shipped
- Fill out and include both the CDC Form 50.34 pdf icon[PDF – 1 page] and Viral Special Pathogens Branch Specimen Submission Information pdf icon[PDF – 2 pages]
- Send specimens by overnight courier (FedEx preferred). Please request early delivery to expedite accessioning and testing. Fax or email airway bill number and packing list to VSPB at (404) 471-2526. For international submitters, consider direct shipment with an airline to expedite arrival at CDC. Do not ship for weekend delivery unless instructed by CDC.
- Subsequent shipments during outbreak may require U.S. Public Health permits.
Potential exposures to blood, body fluids, and other infectious materials must be reported immediately according to your institution’s policies and procedures.
Hospitals should contact their state and/or local health department before contacting CDC. CDC’s Emergency Operations Center is available for consultation at 770-488-7100.
CDC will continue to evaluate new information as it becomes available and will update this guidance as needed.
- Instructions for Submitting Diagnostic Specimens to CDC’s Viral Special Pathogens Branch
- Viral Special Pathogens Branch Specimen Submission Information pdf icon[PDF – 2 pages]
- Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Virus Disease in U.S. Hospitals
- HAN 364: Guidelines for Evaluation of US Patients Suspected of Having Ebola Virus Disease
- Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008
- Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories pdf icon[PDF – 105 pages]
- Submitting Specimens to CDC Specimen Submission Form