Subtitles section Play video Print subtitles >> 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 or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Planners have reviewed content to ensure there is no bias. 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. If you were unable to ask a question please submitted via email to coco@cdc.gov and we will provide you with a response from our presenters. On behalf of COCA, I would like to once again thank our audience for joining us today. And I would also like to thank our presenters. The recording of this call will be posted within the next few days to the COCA website and available on demand in a few days at emergency.cdc.gov/coca. Again, that web address is emergency.cdc.gov/coca. All continuing education protocols are issued online through TCE online. The CDC training and continuing education online system at www.cdc.gov/TCEonline. Those who participated in today's COCA call and wish to receive continuing education should complete the online evaluation by January 20, 2020 with the course core WC 2922. The access code is COCA121919. Those who will participate in the on-demand activity and wish to receive continuing education should complete the online evaluation between January 20, 2020 and January 21, 2022 and use course core WD2922. The access code is COCA121919. These instructions are also available on our coca webpage. Please join us for our next COCA call that will be held on Thursday, January 30, 2020 at 2 PM Eastern time. Where the topic will HHS guidance on patient centered dosage reduction or discontinuation of long-term opioid analgesics. To receive information on upcoming COCA calls or other COCA products and services, join the COCA mailing list by visiting the COCA webpage at emergency.cdc.gov/coca and click on join the COCA mailing list link. To stay connected to the latest news from COCA before to like and follow us on Facebook at facebook.com/CDC clinician outreach and communication activity. Again, thank you for joining us for today's webinar and have a great day.
B1 ebola cdc drc coca outbreak montgomery Update on Ebola Diagnostics at the State and Federal Levels in the United States 1 0 林宜悉 posted on 2020/04/07 More Share Save Report Video vocabulary