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CDC Laboratory Guidance on Ebola

Tom Frieden optimizedFor more than four decades, Ebola virus had only been diagnosed in central or eastern Africa.

Then late this past March, the first cases of Ebola began appearing in a surprising part of the continent. The Ministry of Health in Guinea notified WHO of a rapidly evolving outbreak of Ebola virus disease. The outbreak in Guinea was the first sign the virus had made the jump across the continent.

Ebola then spread quickly to Sierra Leone and Liberia, and then to Nigeria.

As the world learned of the cases, CDC began receiving questions from American hospital labs. They were looking for guidance on how to handle testing for patients who had recently returned to the U.S. from West Africa with potential Ebola symptoms.

If U.S. hospitals were to run laboratory tests on these patients, how could they be sure their staff could safely handle materials that might contain this dangerous virus? Did they need the kind of personal protective equipment they saw CDC scientists using when they were testing for Ebola?

In order to ensure the safety of laboratory staff and other health care personnel collecting or handling specimens, we recommend they follow established OSHA bloodborne pathogens standards .

During specimen collection, we recommend using personal protective equipment such as full face shield or goggles, masks to cover all of nose and mouth, gloves, and fluid resistant or impermeable gowns. And we note that additional personal protective gear might be required in certain situations.

During laboratory testing, we recommend using personal protective equipment such as 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 Plexiglas splash guard, as well as manufacturer-installed safety features for instruments.

If hospitals follow OSHA standards and lab personnel use appropriate personal protective equipment and adhered to engineered standards, they will not need additional safety measures.

Just a note that the additional personal protective gear and special equipment used by CDC lab workers in our BSL4 labs are because of the additional testing and experiments we must do to further investigate the virus. Those experiments include virus isolation in cell culture, small animal studies to determine pathogenicity, and production of reagents for use by CDC and labs around the world.

We advised hospitals that if they had reason to believe one of their patients might be infected with Ebola — because of recent travel to West Africa and appearance of symptoms — they needed to talk to their state and/or local health department and to us at CDC to determine the need for lab testing. If lab testing was needed, CDC provided appropriate shipping guidelines.

We found no Ebola virus in any of the specimens received and tested at CDC as of mid-August.

Lab-related inquiries to CDC have continued to increase.

To respond, CDC issued “Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Patients with Suspected Infection with Ebola Virus Disease,” with specific guidelines for collecting and transporting specimens.

The test for Ebola is not simple. It’s a real-time assay commonly called RT-PCR, or Reverse Transcription-Polymerase Chain Reaction. While we get the results quickly, contamination and false positives are possible if we’re not scrupulously careful at every step of the process.

Here in the United States, CDC is working with the Department of Defense to expand the number of laboratories able to test for Ebola by using the nation’s Laboratory Response Network, made up primarily of local and state health departments.  We anticipate the first labs being able to test for Ebola outside of CDC in the coming days.

And in Africa, we’re working with international partners, WHO, the Department of Defense, and the National Institutes of Health to scale up laboratory testing there.

Laboratory testing is a critical element in our fight to contain the outbreak of Ebola in West Africa and protect people in Africa and around the world.

We’ve developed this poster with the information you need if you or your colleagues have a patient who should be tested for Ebola. CDC staff stands ready to answer questions and concerns 24/7 at 770-488-7100.

Testing Collection Transport

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CarloKateCDCLaurie McClleandPam Shanholtz Recent comment authors
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Carlo
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Carlo

Gracias

Kate
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Kate

If you advise in this blog post restriction of testing to closed systems (third paragraph), why do I not see this in any of the guidelines posted on the CDC website?

Your points in your fourth paragraph are well taken, that risk assessments need to be done. This has been reflected on the CDC website, but not to the detail you describe here. With increasing use of open and random access systems, and open room designs, why are not these details reflected on the CDC website?

CDC
Guest
CDC

In the Ebola guidance for healthcare workers and specifically for Specimen Handling for Routine Laboratory Testing of persons under investigation (PUI) for Ebola disease (http://www.cdc.gov/vhf/ebola/hcp /safe-specimen-management.html), CDC reminds all laboratory personnel to consider all blood and body fluids as potentially infectious. The guidance further informs laboratory personnel that strict adherence to the OSHA bloodborne pathogen regulations and Standard Precautions protects laboratory workers from bloodborne pathogens, including Ebola. In this guidance, emphasis is placed on the OSHA regulation’s requirement for performance of site-specific risk assessments. These assessments should consider the path of the sample throughout the laboratory, including all work processes… Read more »

Laurie McClleand
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Laurie McClleand

Our laboratory would like the answer to Tianna’s question about decontaminating lab equipment as well. We are unable to get answers from many of the manufacturers. Additionally, CDC says to use the manufacturer’s safety equipment. What if the Chemistry instrumentation isn’t a closed tube system. In other words, you either let automation decap the tube or you do it and in either case have to remove an uncapped tube when testing is complete. Is this safe??

Pam Shanholtz
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Pam Shanholtz

What is the answer to Tianna’s question about lab equipment contamination after running an ebola sample?

Haak
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Tianna
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Tianna

One question that we have come across in laboratory preparedness meetings is ‘is our lab equipment contaminated after running normal blood tests on a suspected patient?’. While the direction from the CDChandouts seems to be ‘go by manufacturer guidelines’, I think most manufacturers didn’t anticipate Ebola. If we were to get a suspected case in the hospital, do any of our automated blood testing machines require special decontamination or can suspected samples run along side other patient samples.

Saurabh Jha
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Saurabh Jha

Congratulations to the CDC.

Yep, this is how a central organization ought to be: effective both within and across the borders.

Here are some simultaneous equations.

Please solve for CDC

WHO + CDC = CDC

WHO – CDC = – CDC

Joe Flower
Guest

Seems odd to say so, but this Ebola outbreak may on balance be a good thing. On the one hand, it is not nearly as concerning a pathogen as it could be if it were airborne or animal borne, if it had a longer incubation period, if it were contagious during incubation, if you could be a carrier and not know it, and if it killed a lower percentage of those infect. Any of those would allow it to spread much further and more rapidly — and each of these are characteristics of other pathogens we have experienced in recent… Read more »

Dr. Z
Guest

So, on a purely tactical level…. It’s the middle of my day – I’m running around like crazy- and I walk into an exam room and there’s a potential patient with Ebola talking to me. * What questions do I ask? * What symptoms do Iook for? * Am I supposed to collect the material or have them walk to the lab and potentially expose others en route? * Do I call Infectious Disease? * Is the CDC hotline available 24-7 if someone is seen in the ER or while on a different time zone than Eastern standard? For all… Read more »

Tom Frieden, MD, MPH
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Tom Frieden, MD, MPH

While I’m in West Africa, I’ve asked CDC’s Emergency Operations Center to respond, Dr. Z. CDC encourages all U.S. health care providers to ask patients about their travel histories to determine if they have traveled to West Africa within the last three weeks. All should know the signs and symptoms of Ebola – fever (greater than 38.6°C or 101.5°F) and additional symptoms, such as severe headache, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage – and know what to do if they have a patient with Ebola symptoms which is to first, properly isolate the patient and then, follow… Read more »

Don't Go Back to Rockville
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Don't Go Back to Rockville

Can you tell us anything about the condition of the Kaiser Permanente patient in South Sacramento?

Tom Frieden, MD
Guest
Tom Frieden, MD

As of today, no confirmed Ebola cases have been reported in the United States. We’ve received many calls from health departments and hospitals about suspected Ebola cases in travelers from the affected countries. These calls have been triaged, with some samples being sent to CDC for testing. Samples are being tested as they are received.
All samples sent to CDC, including those of the patient in California, have been negative.