My name is Charlie Hill. I am the Director of the Molecular Diagnostics Laboratory for Emory University Hospital and was the Medical Director for our Serious Communicable Diseases Unit Laboratory during our activation for Ebola patients. going to be talking about the laboratory response for Ebola. So in general. A dedicated laboratory for patients under investigation, or known positive Ebola patients isn't necessary. But, we have to find a way to adequately protect our staff from blood and body fluid exposures, and we have to provide clinically relevant, quality test results for our patients. There are now guidelines in appropriate collection and transport of samples for suspected Ebola patients, and these have been provided by the CDC and also the World Health Organization. Patients under investigation fall under three possible categories, low risk, intermediate risk, and high risk is designated by the CDC and WHO. Because it may take up to three days, after symptoms appear, before virus reaches detectable levels. So, what happens is, we collect one or more blood, ETEA tubes. That's a standard blood tube, that's a four milliliter draw that we test for virus. Now, what we do while we're waiting on that viral testing to be completed. Depends on the individual laboratory because if the adequate resources are there to do additional testing in a protected way, that can be done as well. The risk assessment, while it falls under three categories, the laboratory generally considers only two. Those that require testing for Ebola, and those that don't. The patient doesn't require testing for Ebola. Those samples tend to just go to the main laboratory for regular evaluation. The samples are collected for those patients that do need testing by personnel trained in the appropriate personal protective equipment, and transported in a safe fashion to the laboratory. That transport requires that the specimen be in a durable, leak proof container. In a way that it is unlikely to provide risk to any of the people handling the transporting container. One very important aspect of this, because Ebola does fall under a category of a potential agent of bioterrorism, is that we have to monitor disposition of all of the specimens until we know whether the specimens are positive for Ebola virus or not. There are a number of test available from various vendors for Ebola testing. The current paradigm is that you should test for Ebola nucleic acid, Ebola RNA. And these Ebola RNA tests have been given emergency use authorization under the FDA for the United States. There are a few that only available in designated laboratories. There's a Department of Defense reverse transcription PCR. CDC has two different reverse-transcription PCRs, and there is a commercial entity, BioFire Defense, that provides the FilmArray diagnostic for Ebola. In CLIA certified laboratories, clinical laboratories that are certified for moderate or high complexity testing,. BioFire Defense provides the FilmArray Biothreart-E test which is available commercially. There are two other test available under emergency use authorization for high complexity laboratories only from two other commercial vendors. Emery's approach to persons under investigation is the patients determined to be at risk by the emergency department. The emergency physician then notifies the serious communicable diseases unit physician on call, who does an additional risk evaluation and determines if testing is necessary for Ebola. That physician notifies our serious communicable diseases unit laboratory director on call, who then activates the SCDU lab. The lab director on call then notifies the testing personnel who will come into the serious serious communicable diseases unit laboratory, which is separate from the main hospital lab. The screening sample is drawn at the bedside where the patient currently is sequestered, and transported to the SCDU laboratory. Screening test results are available in one to one and a half hours after receipt. And the basic labs may also be performed more of as a convenience during that time period because the laboratory technologist is waiting on that result to. To complete. For specimen transport within the healthcare facility, we utilize a durable leak proof container, usually, a plastic box with locking handles. And we may use the same or similar, containers that are typically used for shipping category A pathogens. Those are available commercially. We do not use the pneumatic tube system that we would normally transport patient specimens through because of the risk of a tube rupturing, and contaminating the pneumatic tube system. Most importantly we have to minimize the risk of breakage of the tubes or spilling of the samples. Between facilities espe-, even for patients under investigation. Any time a sample that might have a category A pathogen is going to travel on a public conveyance or on roads within the United States requires adherence to the hazardous materials regulations of the U.S. Department of Transportation. There are shipping containers that are designed to minimize the risk of spills. Even in the event of an automobile or airplane accident, these, commercial products can be shipped through a number of shippers within the United States, carriers such as Federal Express, because they do have the appropriate certifications to transport them. Once the specimen is received and testing for Ebola is completed. It is then necessary to change the status of the patient depending on the particular result that was generated. So, for positive patients, those individuals would be admitted to our serious communicable diseases unit, and further care would be provided in that very controlled environment. With regard to negative patients, typically what will happen is that those patients are continued to be monitored for, monitored for symptomatology for an additional number of days. Up to 21 days from the initial symptoms. So that we can verify that they did not in fact have the Ebola virus disease.
