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  • >> Good afternoon.

  • I'm Commander Ibad Khan and I'm representing the Clinician

  • Outreach and Communication Activity, COCA,

  • with the emergency risk communication branch

  • at the Centers for Disease Control and Prevention.

  • I'd like to welcome you to today's COCA call,

  • update on Ebola diagnostics at the state

  • and federal levels in the United States.

  • You may participate in today's presentation via webinar

  • or you may download the slides if you are unable

  • to access the webinar.

  • The PowerPoint slides and the webinar link can be found

  • on our COCA webpage at emergency.cdc.gov/coca.

  • Again that web address is emergency.cdc.gov/coca.

  • Once you reach the webinar page,

  • the PowerPoint slides can be found

  • under the call materials tab.

  • Free continuing education is offered for this webinar.

  • Instructions on how to earn continuing education will be

  • provided at the end of the call.

  • In compliance with continuing education requirements, CDC,

  • our planners, our presenters, and their spouses'/ partners wish

  • to disclose they have no financial interests

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  • of commercial products,

  • suppliers of commercial services,

  • or commercial supporters.

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  • The presentation will not include any discussion

  • of the unlabeled use of product or a product

  • under investigational use.

  • CDC did not accept commercial support

  • for this continuing education activity.

  • After the presentation, there will be a Q&A session.

  • You may submit questions at any time during the presentation

  • through the Zoom webinar system by clicking the Q&A button

  • at the bottom of your screen.

  • And then type in your question.

  • Please do not ask a question using the chat button.

  • Questions regarding the webinar should be entered using only the

  • Q&A button.

  • For those who have media questions,

  • please contact CDC media relations at 404-639-3286,

  • or send an email to media@CDC.gov.

  • If you're a patient please refer your questions

  • to your healthcare provider.

  • At the conclusion of today's webinar,

  • participants will be able to accomplish the following.

  • Discuss procedures for assessing ill travelers returning

  • from the outbreak area, including consultation

  • with the relevant public health authorities.

  • Describe CDC's role in providing technical support

  • and testing approval for persons under investigation

  • for Ebolavirus infection.

  • Review the procedure for reporting and consulting

  • on a suspected case of Ebola in the United States.

  • Discuss considerations and limitations for domestic use

  • of novel rapid diagnostic tests for Ebola.

  • And discuss how to coordinate between clinicians,

  • state health departments, and CDC as it pertains

  • to domestic Ebola preparedness and diagnostics.

  • I would now like to introduce our presenters

  • for today's webinar.

  • Our first presenter is Captain Joel Montgomery.

  • Capt. Montgomery is the chief

  • of the Viral Special pathogens Branch at CDC.

  • He oversees a diverse portfolio

  • of public health research response

  • and partner country capacity enhancement

  • to high consequence pathogens such as Ebola.

  • Capt. Montgomery brings many years

  • of in-depth global experience as a laboratorian, microbiologist,

  • and epidemiologist to his role.

  • Where he is responsible for coordinating scientific efforts

  • in 10 global disease detection country offices.

  • And implementing technical aspects

  • of the global health security agenda.

  • Our second presenter is Dr. Julie Villanueva.

  • Dr. Villanueva is the chief of the Laboratory Preparedness

  • and Response Branch at CDC.

  • In this role, she oversees the biological component

  • of the laboratory response network,

  • which is an integrated domestic and international network

  • of laboratories designed to respond quickly to biological,

  • chemical, and radiological threats

  • and other high priority public health emergencies.

  • I'll now turn it over to Capt.

  • Montgomery.

  • Capt. Montgomery, you may begin.

  • >> Thanks Commander Khan.

  • Thank you for the opportunity to speak with you all today.

  • As Commander Khan mentioned, I'm Dr. Joel Montgomery Chief

  • of the Viral Special Pathogens branch.

  • In today's presentation Dr. Julie Villanueva

  • and I will cover the following topics.

  • First, we'll provide a historical overview of Ebola

  • and give an update on the current outbreak in the DRC,

  • or Democratic Republic of the Congo.

  • We'll also provide guidance and a step-by-step process on how

  • to acquire a laboratory diagnosis of Ebola in a person

  • or persons under investigation.

  • We'll provide an overview and functions

  • of the US Laboratory Response Network or LRN.

  • And finally, we'll provide a description

  • of the current FDA approved Ebola Rapid Diagnostic Test

  • developed by OraSure and its intended use, limitations,

  • and considerations for testing of persons under investigation

  • or suspect Ebola cases patients.

  • Ebolavirus disease is a rare and deadly disease caused

  • by infection with one of the species in the genus Ebolavirus.

  • Four of these species can cause disease in humans,

  • and other can cause disease in nonhuman primates and pigs.

  • And one species is not known

  • to cause disease in humans or animals.

  • I'll describe these in more detail in subsequent slides.

  • Ebolavirus was first discovered in 1976, near the Ebola River

  • in what is now known

  • as the Democratic Republic of the Congo.

  • Since then outbreaks have appeared sporadically in East,

  • Central, and West Africa.

  • There have been 28 independent outbreaks recorded in humans

  • in Africa since that time,

  • including this most recent outbreak in DRC.

  • This is 10th Ebola outbreak in DRC on record.

  • Based on evidence and nature of other similar viruses,

  • we believe that Ebola is an animal-borne or zoonotic disease

  • with bats being the most likely animal reservoir

  • or primary source for the initial introduction

  • or spillover into human populations.

  • The spillover event from the natural reservoir,

  • presumably a bat, is thought to occur through direct contact

  • with a bat, such as through hunting or through contact

  • with bat excretions and/or bodily/fluids such as urine,

  • feces, saliva, or blood.

  • Once the initial introduction into a human,

  • known as the index case has taken place,

  • subsequent transmission from person-to-person may occur

  • in healthcare settings

  • and resource constrained settings often due

  • to a breakdown in proper infection prevention

  • and control procedures.

  • Additional transmission within the general community may

  • and often does occur, as in the current situation

  • in DRC frequently as a result of poor access to healthcare.

  • The current outbreak in eastern DRC is the second largest

  • Ebola outbreak ever recorded.

  • And the largest outbreak DRC has experienced to date.

  • Currently, there are 6 known

  • and recognized species of Ebolavirus.

  • Zaire ebolavirus, Sudan ebolavirus,

  • Bundibugyo ebolavirus, Tai Forest ebolavirus,

  • Reston and Bombali ebolaviruses.

  • Local transmission, outbreaks, and/or imported cases

  • of Zaire ebolavirus on the continent

  • of Africa have occurred in the DRC Republic of Congo, Gabon,

  • Guinea, Sierra Leone, Liberia, Mali, Senegal,

  • Nigeria, and South Africa.

  • For Sudan ebolavirus, outbreaks have been restricted

  • to South Sudan and Uganda.

  • Bundibugyo ebolavirus has occurred in DRC and Uganda.

  • And finally, Tai Forest ebolavirus outbreaks

  • or cases have occurred only in Cote d'Ivoire or Ivory Coast.

  • All species, other than Reston and Bombali are known

  • to cause human disease.

  • The latter two species have only been associated

  • with either nonhuman primate and/or pig outbreaks,

  • that is Reston ebolavirus in Reston Virginia and Texas.

  • With some evidence of transmission to humans

  • with no overt disease.

  • While Bombali ebolavirus has only been identified

  • in the Angolan free-tailed bat and little free-tailed bat.

  • First in Sierra Leone, and later, in Guinea and Kenya.

  • Ebola spreads through direct contact.

  • Through broken skin or unprotect mucous membranes

  • with any or all the following.

  • Blood or bodily fluids such as urine, saliva, sweat, feces,

  • vomits, semen, breast milk, and vaginal fluids from someone

  • who is sick with, or has died from Ebola.

  • Through fomite contact contaminated

  • with infected bodily fluids.

  • For example, needles, syringes, bedding.

  • Contact with infected animals, as I mentioned previously,

  • such as fruit bats, and/or nonhuman primates.

  • And from semen from an individual

  • who has recovered from Ebola.

  • The signs and symptoms often grouped

  • as either dry or wet symptoms.

  • May include the following.

  • Fever, severe headache, fatigue,

  • muscle pain, rash, abdominal pain.

  • The so-called dry symptoms.

  • These are often followed by the wet symptoms.

  • Including vomiting, diarrhea, unexplained bleeding,

  • and in females, miscarriage.

  • It's important to note and reemphasize

  • that a person infected with Ebolavirus is not contagious

  • until symptoms appear.

  • The progression of Ebolavirus disease begins

  • with the incubation period.

  • The time from exposure to when signs and symptoms first appear.

  • Incubation for EBD is 2-21 days with an average

  • of 8-10 days for most cases.

  • Again, a person infected

  • with Ebola cannot spread the virus prior to symptom onset.

  • Wet symptoms generally develop approximately four days

  • into the course of illness.

  • And patients with Ebolavirus disease become increasingly

  • contagious or infectious, as the illness advances.

  • Without treatment, supportive care,

  • or therapeutic intervention, generally, death occurs within 7

  • to 10 days after illness onset.

  • Finally, the concentration of the virus

  • in the body is the greatest at the time of death.

  • And the point when an individual is most infectious to others.

  • The current outbreak in the DRC was confirmed in August 2018.

  • And on September 26, 2018, the US Agency

  • for International Development

  • or USAID activated a disaster assistance response team,

  • co-led by CDC.

  • On 13 June 2019, due to the unabated progression

  • of the outbreak, increasing complexity of CDC engagement,

  • and a confirmed case in neighboring Uganda,

  • CDC activated its emergency operation center.

  • It's the first urban outbreak in DRC occurring

  • in a highly insecure, densely populated area near

  • international borders

  • with extensive cross-border movement and trade.

  • From 20 November to 10 December,

  • there have been 42 confirmed cases in 4 health zones of DRC.

  • The outbreak does show signs of slowing, however,

  • upticks of violence, insecurity,

  • and stability have hampered the response activities.

  • I'll discuss this in more detail in subsequent slides.

  • But as you can see from the maps, the current outbreak

  • in DRC is affecting very remote areas of the country,

  • including North Kivu and the three provinces shown in detail

  • on a map on the left-hand side.

  • The map on the right shows just how distant the current Ebola

  • transmission zone is from Kinshasa, the capital of DRC.

  • The outbreak zone is approximately 1600 km,

  • or 1000 miles by air, or 3000 km or 1900 miles by ground.

  • Therefore, the ease of population movement or movement

  • of an individual outside of these areas

  • to other locations including the United States,

  • via Kinshasa is very difficult but not impossible.

  • It is also very distant from other large cities in the region

  • such as Kampala, Uganda.

  • And we have and are seeing movement

  • of individuals across the borders.

  • The current outbreak

  • and in eastern DRC is the second largest

  • of all outbreak ever recorded.

  • And the largest outbreak DRC has experienced to date.

  • As of 18 December, there have been more than 3300 cases

  • and 2200 deaths in 29 health zones.

  • The provinces affected by this outbreak border Uganda, Rwanda,

  • South Sudan, and Burgundy with significant population movement

  • across poorest country borders.

  • Case movement poses increased risk of new infections

  • and a resurgent of cases in health zones that have gone

  • without reporting cases for some time.

  • This is further complicated by the possibility

  • of infected people moving into areas where insecurity

  • and violence make it impossible for cases to be isolated,

  • contacts to be traced, and vaccination to occur.

  • This past fall, cases fell significantly.

  • And the geography of the outbreak was reduced.

  • However, violence and unrest

  • since late November have significantly impeded the Ebola

  • response efforts in the remaining outbreak areas.

  • An attack specifically targeting the Ebola response

  • for non-USG US government Ebola responders were killed

  • and 27 November.

  • And as a result, the response has been partially

  • or completely interrupted in key communities.

  • The affected DRC population have low levels of trust

  • in the government and the international community.

  • And violence has hampered the public health response efforts.

  • As previously mentioned, the risk of Ebola importation

  • to the US is low at this time.

  • But we must remain vigilant.

  • This assessment is based on the travel volume

  • and travel patterns from outbreak areas to the US.

  • As well as the implementation of border screening measures

  • at key airports and ports in DRC and neighboring countries

  • such as Sudan, Rwanda, and Uganda.

  • There are no direct flights to the US from DRC.

  • The total number of travelers from all DRC,

  • including nonaffected areas

  • to the US was less than 16,000 in 2018.

  • On average, of approximately 325,000 air travelers arriving

  • in the United States daily from abroad,

  • only 43 travelers have been from DRC.

  • Largely from unaffected regions.

  • The persons at risk are travelers to the eastern DRC

  • where the outbreak is occurring.

  • And those who have had contact with someone infected with Ebola.

  • I'll now hand over the presentation

  • to Dr. Villanueva.

  • >> Thank you, Capt.

  • Montgomery.

  • And thank you all for your time today.

  • I'm Dr. Julie Villanueva of the Laboratory Preparedness

  • and Response branch Chief at CDC.

  • And I'm here to talk about the role

  • of the Laboratory Response Network,

  • or the LRN in testing specimens from patients

  • with suspected Ebolavirus disease, as well as the role

  • and limitations of Ebola rapid diagnostic tests.

  • I'll begin by explaining the role of the LRN

  • in Ebolavirus disease testing.

  • The Laboratory Response Network, or the LRN,

  • was founded to create and sustain a network

  • of laboratories that can respond to biological

  • and chemical threats as well as public health emergencies.

  • In the years since its creation,

  • the LRN has played an instrumental role

  • in improving domestic public health infrastructure by helping

  • to boost state, local, and federal laboratory capability.

  • The LRN includes not only a network of federal, state,

  • and local public health laboratories

  • but is also a vast national network of sentinel

  • and clinical laboratories.

  • Our clinicians serve as the entry point to this network.

  • And we rely on you to alert us to the usual findings.

  • Currently, there are 69 LRN laboratories primarily in state

  • and local public health laboratories

  • that can perform the CDC real-time reverse transcriptase

  • polymerase chain reaction, or rRT-PCR Ebola tests

  • which I will explain in the next slide.

  • Healthcare providers and clinicians that are interested

  • in testing a patient

  • for Ebolavirus should first contact their state

  • or local public health authorities.

  • After you consult with your state

  • or local public health authorities,

  • together you will contact and consult with CDC.

  • If there is agreement that the patient meets the criteria

  • for persons under investigation for Ebolavirus disease,

  • then specimens may be collected and sent for testing at one

  • of the 69 LRN laboratories that are qualified

  • to conduct Ebola testing using the CDC assays.

  • The test used

  • by LRN laboratories are the CDC Ebolavirus NPrRT-PCR assay

  • and the CDC Ebolavirus BP 40 rRT-PCR assay.

  • These assays are intended for the detection of Ebolavirus RNA,

  • species Zaire ebolavirus in clinical specimens.

  • These tests have been authorized for use by the FDA

  • under emergency use authorization.

  • And both tests are conducted for a specimen from a person

  • under investigation for Ebolavirus disease.

  • Each of these assays use a real-time reverse transcriptase

  • polymerase chain reaction, or RT-PCR technology.

  • This is a commonly used diagnostic method

  • because of its ability to detect low levels of Ebolavirus.

  • PCR methods can also detect the presence

  • of a few virus particles in a small amount of blood.

  • But the ability to detect the virus increases as the amount

  • of virus increases during an active infection.

  • Acceptable specimens for testing

  • with these tests are whole blood, serum, and plasma.

  • Urine specimen are also acceptable only when tested

  • in conjunction with the patient matched whole blood,

  • serum, or plasma specimen.

  • Please consult the website listed on slide 21

  • for more information on specimen collection and transport.

  • The results from the CDC test are either negative,

  • inconclusive, or presumptive positive.

  • A negative results means Ebolavirus RNA was not detected.

  • If you receive this result, consult state

  • and local health authorities and CDC to determine

  • if additional patient testing is warranted.

  • Depending on the patient's travel history, signs,

  • and symptoms, it may be helpful

  • to perform diagnostic tests for other pathogens.

  • An inconclusive result means the test is not interpretable.

  • This result may be associated

  • with an inadequate specimen being collected

  • or a problem during specimen transport.

  • If you received this result consult state

  • and local health authorities and CDC to determine

  • if additional specimens need to be collected

  • from the patient and re-tested.

  • A presumptive positive result means Ebolavirus RNA

  • was detected.

  • Additional testing at the CDC is required

  • for the definitive identification of Ebolavirus.

  • Consult with your state and local health authorities and CDC

  • for confirmatory testing as well as guidance

  • for patient management.

  • Confirmatory testing at CDC is required to confirm the presence

  • of Ebola RNA and other viral hemorrhagic fevers,

  • as well as to differentiate

  • between the different species of Ebolavirus.

  • State and local public health authorities will coordinate

  • confirmatory testing at CDC for all specimens

  • that test presumptive positive

  • with the CDC Ebola, rRT-PCR assays.

  • Now, I'd like to discuss the intended use, some limitations

  • and consideration of Ebola Rapid Diagnostic Test.

  • In October of 2019, the US Food

  • and Drug Administration allowed marketing

  • of the OraQuick Ebola Rapid Antigen Test,

  • which is a Rapid Diagnostic Test or RDT for the detection

  • of Ebola virus in both symptomatic patients

  • and deceased individuals.

  • This is the first Ebola rapid agnostic test

  • that FDA has cleared by the 510K process

  • for marketing in the United States.

  • The test is an antigen capture lateral flow immunoassay capable

  • of detecting antigens of species including Zaire ebolavirus,

  • Bundibugyo ebolavirus, and Sudan ebolavirus.

  • Ebola Rapid Diagnostic Tests were originally developed

  • as a tool for rapid presumptive diagnosis

  • of Ebola in outbreak settings.

  • They have utility for low resource areas where access

  • to more sensitive molecular confirmatory testing is

  • a challenge.

  • These tests are not intended to be used

  • for general Ebola infection screening or testing

  • of asymptomatic individuals, or those without risk factors

  • and compatible symptoms of Ebola virus disease.

  • And as with any diagnostic tests, we encourage you

  • to please read the manufacturer's instructions

  • for use for additional important information about the test.

  • Like all diagnostic tests,

  • the OraQuick Ebola Rapid Antigen Test has some limitations.

  • The OraQuick Ebola Rapid Antigen Test cannot differentiate

  • between the three species of Ebolavirus that it detects.

  • CDC recommends that all results, both positive or negative

  • from the OraQuick Ebola Rapid Antigen Test are presumptive

  • and must be verified through real-time reverse transcriptase

  • polymerase chain reaction testing performed

  • in the Laboratory Response Network or at CDC.

  • Results from an Ebola Rapid Diagnostic alone should not be

  • used to make certain public health decisions.

  • Rapid diagnostic test results should not be used to rule

  • out Ebola infection, or to determine the use or type

  • of infection prevention and control precautions

  • when managing a patient with compatible symptoms

  • and epidemiological risk factors.

  • And now I'd like to turn the call back to Capt.

  • Montgomery.

  • >> Thanks, Dr. Villanueva.

  • So, in summary.

  • All of our ET results, both positive

  • and negative are presumptive and must be verified

  • through real time RT-PCR testing available at one

  • of the 69 LRN laboratories in 49 states and at the CDC.

  • The OraQuick Ebola Rapid Antigen Test should be used only

  • in circumstances where more sensitive molecular testing

  • at LRN laboratories or CDC is unavailable.

  • Which is being used in DRC for example, for testing of cadavers

  • for safe and dignified burials.

  • Healthcare providers who may be concerned about a patient

  • with Ebolavirus infection, should first contact their local

  • or state public health authorities

  • for consultation and guidance.

  • RDT results alone should not be used to rule

  • out Ebolavirus infection, or to determine the use or type

  • of infection prevention and control precautions,

  • when managing a patient with compatible symptoms

  • and epidemiological risk factors.

  • Finally, CDC is available to provide consultation,

  • technical assistance,

  • and confirmatory testing as necessary.

  • And with that I'll close and we are open for questions.

  • >> Thank you so much Capt.

  • Montgomery and Dr. Villeneuve for providing our audience

  • with this important update on Ebola diagnostics at the state

  • and federal levels in the United States.

  • We appreciate your time and value your insights.

  • We will now begin our Q&A session.

  • Please remember, you may submit questions

  • through the webinar system by clicking the Q&A button

  • at the bottom of the screen and then typing your question.

  • Again, please do not ask a question using the chat button.

  • Our first question is regarding the confirmatory testing results

  • from RDT.

  • Can you please elaborate if it's the positive RDT results

  • or the negative RDT results that need to be verified

  • through confirmatory testing?

  • >> Thank you, this is Julie Villeneuve.

  • All results, both positive and negative need to be confirmed

  • with a molecular assay.

  • >> Thank you for that.

  • And our next question is also similarly related.

  • And the question asks, can you please differentiate again the

  • difference between test results being inconclusive

  • or presumptive positive.

  • >> Of course, this is Julie Villeneuve again.

  • An inconclusive result means we can't interpret the test.

  • And so, that might mean

  • that there was an inadequate specimen that was collected.

  • Or, there may have been a problem

  • that could have damaged the specimen during transport

  • or elsewhere.

  • And so, the inconclusive result means you need to talk

  • to your state and local health authorities as well as CDC

  • and determine whether additional samples need to be collected

  • from that patient and retested.

  • >> Thank you.

  • Another question is regarding the specificity

  • and the sensitivity of RDT for Ebola.

  • Can you speak on that please?

  • >> So, again, this is Julie Villeneuve.

  • There is very detailed information

  • in the package insert from the manufacturer.

  • And I strongly encourage anyone that's interested in this test

  • to read that package insert.

  • And it has all the information about the sensitivity

  • and specificity of the test.

  • >> Thank you.

  • A follow-up question on that is the RDT available commercially?

  • >> Yeah. This is Dr. Joel Montgomery.

  • The OraSure RDT is available commercially.

  • But you would have to contact OraSure.

  • >> Thank you.

  • Also can the RDT be used effectively

  • when the patient is asymptomatic?

  • >> This is Dr. Joel Montgomery.

  • No, it cannot.

  • >> Thank you.

  • Another question we have is regarding what species

  • of Ebolavirus type does the PCR detect compared to the RDT?

  • >> Yeah, so the RDT detects Bundibugyo,

  • Zaire, and Sudan Ebolavirus.

  • >> And the rRT-PCA assay detects the Zaire Ebolavirus.

  • >> The CDC assay correct.

  • >> Thank you.

  • Another question is for clinicians that have

  • to submit samples to the agency.

  • Can you please talk again about the procedure?

  • If they should contact CDC directly or if they should reach

  • out to their health departments first.

  • >> This is Dr. Joel Montgomery.

  • Please communicate with your state

  • and local health departments first.

  • >> Thank you for that clarification.

  • And what is the earliest time that samples can be submitted.

  • Is it three days after patient shows symptoms?

  • Or can they be submitted sooner than that?

  • >> Hi, this is Dr. Katelyn Casiboom [assumed spelling]

  • with Viral Special Pathogens Branch.

  • Specimens that are collected from suspect Ebola patients,

  • if they're collected within 72 hours after symptom onset,

  • and the result is negative, and clinical suspicion remains,

  • it's important that they are, another specimen is collected

  • after 72 hours and retested.

  • >> Thank you.

  • Another question, comparing the different diagnostics asks,

  • what's the estimated turnaround time of the RT-PCR process done

  • at an LRN site compared to the use of RDT

  • at a healthcare facility.

  • >> So, this is Julie Villeneuve,

  • the RDP result is relatively rapid, and I would need

  • to consult package insert to give you the exact,

  • within 30 minutes, thank you.

  • The turnaround time at and LRN laboratory will vary.

  • But on average a real-time RT-PCR test itself takes

  • approximately four hours.

  • But please consider that specimens need to be received,

  • accessioned and data needs to be reviewed

  • and analyzed before a report is sent.

  • So that would be variable and you would need

  • to contact your state and local public health authorities

  • for more detailed information.

  • >> Thank you for that clarification.

  • Another inquirer is wondering

  • if there are CDC-based trainings available

  • to assist clinical labs

  • with safely packaging shipping specimens

  • to public health labs and/or to CDC.

  • Or if there is a resource available

  • that you can direct them to.

  • >> Commander Khan can you please repeat the question?

  • Commander Kahn could you please repeat the last question?

  • >> Yes, my apologies for the technical difficulties.

  • The question asks does the CDC have available training

  • or resources that will allow clinical labs to learn how

  • to safely package and ship specimens to public health labs.

  • >> So, this is Julie Villeneuve, there is guidance

  • on the CDC website that you can refer to.

  • If you go to the main Ebola page, if you click

  • on for laboratorians and there's a guidance

  • on specimen collection and transport.

  • I would also encourage you to contact your state

  • and local public health authorities

  • who can also assist you with this.

  • >> Thank you.

  • Another question asks during your presentation you mentioned

  • the criteria of patients without risk factors

  • when it comes to RDT.

  • Can you please elaborate on that?

  • >> So, this is Julie Villeneuve.

  • Patients without risk factors, signs of symptoms associated

  • with Ebolavirus disease should not be tested using any Ebola

  • diagnostic tests.

  • >> Thank you.

  • Another question is regarding biosafety precautions

  • or personal protective equipment requirements for RDT.

  • That's first part.

  • The second part is who do you recommend should perform

  • the testing?

  • >> Hi, this is Ryan Fagan

  • from CDC Division of Healthcare Quality Promotion.

  • I'll answer the first part of that,

  • which is any person entering the room

  • to collect the specimen should be following the same personal

  • protective equipment guidance

  • that other healthcare personnel would be following.

  • And that's consistent

  • with what's currently posted on the CDC website.

  • And there's also a link to the PPE guidance

  • from the specimen collection page

  • that Dr. Villeneuve just referenced.

  • In terms of who performs the test, I'll defer that to others.

  • >> So, this is Julie Villeneuve.

  • Again, I encourage you to read the instructions for use

  • from the manufacturer for more details.

  • But again, the personal protective equipment that's

  • outlined for anyone that manages a specimen should be consistent

  • for safety reasons.

  • And yeah. Yeah.

  • And again, sorry the other thing I wanted to add is

  • that training is required.

  • And the manufacturer can provide you more information

  • about the training associated with that test.

  • >> Thank you.

  • Next question asks do you have a recommended course of action

  • if the rapid test is negative,

  • but the patient has clinical symptoms suggestive

  • of Ebola infection.

  • >> Hi, this is Julie Villeneuve.

  • Regardless of the result of the rapid test, and if signs

  • and symptoms are associated with Ebolavirus disease

  • and the patient meets epidemiological risk factors,

  • a specimen should be tested for Ebolavirus

  • at the LRN laboratory.

  • >> Thank you.

  • A follow-up question on that is can that sort

  • of confirmatory testing be done at a hospital,

  • or do you recommend LRN specifically.

  • >> So, the CDC recommends that all

  • of those specimens are tested

  • within a Laboratory Response Network or at CDC.

  • >> Thank you.

  • Another question is regarding the need to use the RDT

  • since there are 69 LRN locations.

  • Can you explain when or what the benefit of having the RDT is.

  • >> So, this is Capt.

  • Montgomery.

  • The RDT I think has a lot of use

  • in resource constrained settings, which is being used

  • in DRC right now in cadaver surveillance

  • for safe and dignified burial.

  • Beyond the current setting in DRC,

  • we would again strongly recommend

  • that you use the LRN network

  • or CDC using the advanced molecular diagnostics.

  • >> Another question, similar lines is the RDT approved

  • for use at bedside?

  • >> It is a point-of-care test.

  • So, it could be used at bedside.

  • >> And our final question asks does CDC have data

  • on how many Ebolavirus disease diagnostic requests the agency

  • has received since this outbreak began?

  • >> We've received 49 requests and we've tested 1 to date.

  • >> Thank you.

  • And this concludes our question-and-answer session.

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  • On behalf of COCA, I would

  • like to once again thank our audience for joining us today.

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>> Good afternoon.

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