IINTERIM GUIDANCE FOR SPECIMEN
COLLECTION, TRANSPORT, TESTING AND SUBMISSION FOR PATIENTS WITH SUSPECTED
INFECTION WITH EBOLA VIRUS
Background
CDC is working with the World Health
Organization (WHO), the ministries of health, and other international organizations
in response to an outbreak of EVD in West Africa, which was first reported in
late March 2014. This is the largest outbreak of Ebola virus disease (EVD) ever
documented and the first recorded in West Africa. For the latest information on
the outbreak, see the 2014 Ebola
Outbreak in West Africa highlights.
EVD is one of numerous viral
hemorrhagic fevers (VHF). It is a severe, often fatal disease in human and
nonhuman primates. EVD is spread by direct contact with the blood or secretions
(urine, feces, semen, breast milk, and possibly others) of an infected person
or exposure to objects that have been contaminated with infected secretions.
The incubation period is usually 8–10 days (rarely ranging from 2 to 21 days).
Patients can transmit the virus while febrile and through later stages of
disease, as well as postmortem.
hospitals can safely manage a patient
with EVD by following recommended isolation and infection control procedures.
Standard, contact, and droplet precautions are recommended for management of
hospitalized patients with known or suspected EVD.
Potentially infectious diagnostic
specimens are routinely handled and tested in U.S. laboratories in a safe
manner, through adherence to standard safety precautions as outlined below.
Purpose
This document provides interim
guidance for laboratorians and other healthcare personnel collecting or
handling specimens on appropriate specimen collection, transport and testing of
specimens from patients who are suspected to be infected with Ebola virus.
Infection
Control for Collecting and Handling Specimens
It is
expected that all laboratorians and other healthcare personnel collecting or
handling specimens follow established standards compliant with the OSHA
bloodborne pathogens standard, which encompasses blood
and other potentially infectious materials. This includes wearing appropriate
personal protective equipment (PPE) and adhering to engineered safeguards, for
all specimens regardless of whether they are identified as being infectious.
Recommendations for specimen
collection: full
face shield or goggles, masks to cover all of nose and mouth, gloves, fluid
resistant or impermeable gowns. Additional PPE may be required in certain
situations.
Recommendations for laboratory
testing: full
face shield or goggles, masks to cover all of nose and mouth, gloves, fluid
resistant or impermeable gowns AND use of a certified class II Biosafety
cabinet or plexiglass splash guard, as well as manufacturer-installed safety
features for instruments
Specimen
Handling for Routine Laboratory Testing (not for Ebola Diagnosis)
Routine laboratory testing includes
traditional chemistry, hematology, and other laboratory testing used to support
and treat patients. Precautions as described above offer appropriate protection
for healthcare personnel performing laboratory testing on specimens from
patients with suspected infection with Ebola virus. These precautions include
both manufacturer installed safety features for instruments and the environment
as well as PPE specified in the box above.
When used according to the
manufacturer’s instructions, Environmental Protection Agency (EPA)-registered
disinfectants routinely used to decontaminate the laboratory environment
(benchtops and surfaces) and the laboratory instrumentation are sufficient to
inactivate enveloped viruses, such as influenza, hepatitis C, and Ebola
viruses.
Ebola virus is detected in blood only
after onset of symptoms, most notably fever. It may take up to 3 days
post-onset of symptoms for the virus to reach detectable levels. Virus is
generally detectable by real-time RT-PCR from 3-10 days post-onset of symptoms,
but has been detected for several months in certain secretions. Specimens
ideally should be taken when a symptomatic patient reports to a healthcare
facility and is suspected of having an EVD exposure; however, if the onset of
symptoms is <3 days, a subsequent specimen will be required to completely
rule-out EVD.
A minimum volume of 4mL whole blood
preserved with EDTA, clot activator, sodium polyanethol sulfonate (SPS), or
citrate in plastic
collection tubes can be submitted for EVD testing. Do not submit specimens in
glass containers. Do not submit specimens preserved in heparin tubes. Specimens
should be stored at 4°C or frozen. Specimens other than blood may be submitted
upon consult. Standard labeling should be applied for each specimen. The
requested test only needs to be identified on the requisition and specimen
submission forms.
Specimens should be stored at 4°C or
frozen.
In compliance with 29 CFR 1910.1030,
specimens should be placed in a durable, leak-proof secondary container for
transport within a facility. To reduce the risk of breakage or leaks, do not
use any pneumatic tube system for transporting suspected EVD specimens.
Specimens collected for EVD testing
should be packaged and shipped without attempting to open collection tubes or
aliquot specimens. Specimens for shipment should be packaged following the
basic triple packaging system which consists of a primary receptacle (a
sealable specimen bag) wrapped with absorbent material, secondary receptacle
(watertight, leak-proof), and an outer shipping package.
The following steps outline the
submission process.
Ø
Hospitals
should follow their state and/or local health department procedures for
notification and consultation for Ebola testing requests
Ø
NO
specimens will be accepted without prior consultation.
Ø
Contact
your state and/or local health department and CDC to determine the proper
category for shipment based on clinical history and risk assessment by CDC.
State guidelines may differ and state or local health departments should be
consulted prior to shipping.
Ø
Email
tracking number.
Ø
Do
not ship for weekend delivery unless instructed
Include the following information:
your name, the patient's name, test(s) requested, date of collection,
laboratory or accession number, and the type of specimen being shipped.
Ø
Include
the Infectious Disease specimen submission forms.
Ø On the outside of the
box, specify how the specimen should be stored:refrigerated or
frozen
Occupational
Health
Potential exposures to blood, body
fluids and other infectious materials must be reported immediately according to
your institution’s policy and procedures.
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