Tag: Ebola Virus

Ebola 2018

Approximately two years after Liberia, the hardest hit and last of the 6 countries to be affected in the largest Ebola outbreak since discovery of the disease in 1976, was declared Ebola-free, the virus has again reared its head. This time, its in the Democratic Republic of the Congo (DRC).

Timeline of the Outbreak:

  • May 3, 2018: a district in the Province of Equateur, DRC, reported 21 cases of undiagnosed illness with 17 deaths. Samples from 5 of these cases were sent to the Institute National Recherche Biomedicale in Kinshasa.
  • May 7: Ebola virus was confirmed by RT-PCR.
  • May 8, 2018: Ebola outbreak declared.
  • May 21: 628 contacts of confirmed or suspected cases listed.
  • May 25: 58 cases and 27 deaths.
  • June 1: the outbreak is contained in the Province of Equateur. This Province covers an area of 130442 km2 and has a population of 2,543,936. Equateur as 16 health zones and 284 health centers – this works out as 1 health center for every 9,000 people! The WHO warns that this outbreak has the potential to expand, and while at the moment there is no international spread, the Congo’s neighbors have been placed on alert. The WHO has distributed personal protective equipment, infrared thermometers, and rapid diagnostic tests to health centers in Equateur as well as neighboring countries.

The WHO considers laboratory diagnostics on of the pillars of the Ebola response. They recommend “strengthening diagnostic capabilities” as part of a strategic approach to the prevention, detection, and control of Ebola. In fact, laboratory diagnostics might be a key to how this epidemic plays out, versus the previous outbreak in West Africa wherein six African countries were affected and over 11,000 patients died. This time, there are rapid tests tests available ranging from lateral flow to molecular.

As part of the DRC’s National Laboratory Strategy developed in response to the outbreak, the GeneXpert confirmatory Ebola PCR test is being used a key sites in mobile laboratories. As of June 1, the WHO has deployed four mobile labs through out Equateur including the epicenter of the outbreak. Government Health Centers are equipped with rapid lateral flow tests: the ReEBOV Antigen Rapid Test released under Emergency Use Approval in 2015. According to WHO documents, this test has a sensitivity of 91% and specificity of 84.6%. Both positives and negatives should be confirmed with RT-PCR. The following is the guidance for the use of rapid tests:

Special settings where rapid antigen for Ebola may be beneficial:

  1. In the investigation of suspected Ebola outbreaks in remote settings where PCR tests are not immediately available. While awaiting confirmatory testing, action can be taken to: a) isolate test-positive patients, b) repeat daily testing on patients who initially tested negative but remain symptomatic, c) mobilize transport of samples for confirmatory testing and initiate outbreak-management procedures.
  2. In settings where the number of cases and suspects arriving for triage and care cannot be managed with the existing health staff and laboratory facilities.

Example situations where rapid antigen detection tests should NOT be used:

  • Individual case management – including for establishing definitive diagnosis or making therapeutic decisisions
  • Certification of Ebola virus-free status prior to medical care for other illnesses
  • Release of Ebola patients from Ebola Treatment Centers
  • Pooled blood samples for community-based testing
  • Testing blood before transfusion
  • Active case finding without confirmatory PCR
  • Any setting where action (quarantine, referral, care) based on results is not possible
  • Airport screening

So to summarize, currently in the Province of Equateur, suspected cases are tested by rapid test for initial triage, then samples are sent to the nearest lab for confirmation (positive or negative) by PCR. A suspected case cannot be released until there is a negative test by PCR. Suspected cases that initially negative by the rapid test are isolated from cases that are initially positive.

What about outside Equateur? I talked to Dr. Tim Rice, a friend and colleague serving as a missionary physician in Vanga, Congo. Vanga is the in Province of Bandundu, the northern neighbor of Equateur. While this province has not had a reported case of Ebola, they are getting ready. I asked him about their readiness plan and any laboratory capabilities they had. They have a rapid test: Ebola rapid lateral flow test from STADA Diagnostik (Germany). This assay detects the Ebola virus antigen VP 40 with a sensitivity of 92% and specificity of 98% (according to the package insert). Serum and throat swabs are acceptable specimens, although it is not clear which matrix was used to determine the performance characteristics. The package insert states that the performance characteristics are still being evaluated. Dr. Rice said they use the rapid test with patients with potential exposure and severely ill with fever.  Someone arriving from the Equatorial province with a fever, even if not severely ill, would be tested and isolated. They are to call the local health department for help in obtaining the correct confirmatory samples, properly storing the sample, alerting the regional and national leaders, and transporting the sample properly protected the 10 hours overland to Kinshasa for confirmatory PCR testing at the Institute National Recherche Biomedicale.

The response to the 2018 Ebola outbreak has been impressive and I sincerely hope that with the benefits of laboratory diagnostics and a vaccine, the world will be spared the devastation experienced in the previous outbreak.

 

Sarah Brown Headshot_small

–Sarah Riley, PhD, DABCC, is an Assistant Professor of Pediatrics and Pathology and Immunology at Washington University in St. Louis School of Medicine. She is passionate about bringing the lab out of the basement and into the forefront of global health.  

Ebola and Stress on Health Care Professionals

A recent letter to the editor of CDC’s Emerging Infectious Diseases discusses the psychological stress of caring for an Ebola patient. The authors wondered if the caregivers of patients with Ebola experienced more stress than other providers. You can read the small study–and the surprising results–here.

Podcast: Answers to Your Ebola Preparedness Questions

The editors of Lab Medicine recently sat down with ASCP President Dr. Finn, Dr. Nancy Cornish from the Centers for Disease Control, and Dr. Lance Peterson from NorthShore HealthSystem to answer your questions about laboratory preparedness for a patient infected with Ebola Virus. You can listen to it here.

Laboratory and Hospital Ebola Response

Laboratories are currently scrambling to define and put into place procedures for dealing with processing and testing of samples from highly infectious patients. The CDC has guidelines for healthcare workers and for laboratories specifically (http://www.cdc.gov/vhf/ebola/hcp/index.html). They also are very willing to help. Because Dallas had actual cases of Ebola, our hospital in Dallas mounted a hospital-wide response, in which the CDC and Texas State and County Health Departments were involved early on and throughout. This blog post describes the plans we instituted.

It quickly became clear that we did not want to transport infectious material through the hospital if we could avoid it, keeping everything infectious isolated in a single area. The hospital cleared an ICU wing which contained two negative pressure rooms, and the laboratory used an ICU room two doors away to create a mini-lab. The entire ICU wing was closed off as an isolation zone. No samples will leave the isolation zone unless they are headed for the CDC or State lab, and those will be couriered directly from the isolation zone.

All testing that can be, will be done on the I-stat in the patient room, including electrolytes, BUN, creatinine, ionized calcium and blood gases. A meeting was held with the ICU physicians who will be treating patients, to ask what testing they could foresee requiring other than those available on the I-stat. Their final list included platelets, CBC and coag tests, and originally also asked for ammonia and liver function tests. The only test we could not provide for them was ammonia. We couldn’t find a way to perform ammonia on a whole blood sample and had decided not to centrifuge any samples due to the possible risks of aerosolizing the sample and additional risks associated with aliquotting samples.

For the coag tests, we chose to use the I-stat PT/INR. Knowing that PT/INR on the I-stat is not FDA approved for anything other than Coumadin monitoring, we performed a full CLIA validation of the PT/INR in order to be able to use it for Ebola patients. Using the I-stat this way causes the PT/INR to become a high-complexity test, therefore only those individuals with appropriate licensure, training and competency will be performing the test at bedside.

Testing other than what is available on the I-stat will be done in the mini-lab set up in the nearby ICU room. It will be performed by lab personnel in full PPE, including PAPR (powered air purifying respirators), 3 layers of gloves, etc, all within the isolation zone. Lab testing in the mini-lab will occur once a day, with a possibility of twice a day. We purchased an Abaxis Piccolo for performing the liver enzymes and a Sysmex pocH-100i for the CBC and platelets. Both these analyzers will be run in the mini-lab room. The piccolo will be run inside a biosafety cabinet (BSC) which was put in the room because the piccolo is not a closed system. Sample pipetting into the piccolo carousel will occur in the BSC.

As far as blood utilization, the plan is to perform a one time, ABO only, blood typing on admission of a patient. A blood bank technologist in full PPE will perform the ABO only blood type manually in the BSC in the mini-lab. This ABO only typing has also been validated on samples allowed to settle rather than being centrifuged. The plan is for any patients to receive type O-negative blood if transfusions are required. However if they should require type-specific blood products for any reason (i.e. shortage of O-negative), it was felt that performing the blood type early before viral titers are really high would be better than waiting.

To work in the isolation wing, personnel must don full isolation PPE, including PAPR, etc, with a multi-step system in place for both donning and doffing the equipment. A buddy system is used throughout, with training on all procedures being continuous. The lab personnel who have volunteered to staff the mini-lab have undergone the PPE training. All of this perhaps excessive care is being taken in order to protect all other patients, as well as all healthcare team members, both lab and non-lab. Although Ebola may never reach our hospital, we live in a world where global travel makes if very likely that we will see patients with this or other highly infectious diseases appear in our facilities. It’s important to be as prepared as possible.

 

-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

 

CDC Press Release–Passenger Notification

CDC and Frontier Airlines Announce Passenger Notification Underway

On the morning of Oct. 14, the second healthcare worker reported to the hospital with a low-grade fever and was isolated. The Centers for Disease Control and Prevention confirms that the second healthcare worker who tested positive last night for Ebola traveled by air Oct. 13, the day before she reported symptoms.

Because of the proximity in time between the evening flight and first report of illness the following morning, CDC is reaching out to passengers who flew on Frontier Airlines flight 1143 Cleveland to Dallas/Fort Worth Oct. 13.

CDC is asking all 132 passengers on Frontier Airlines flight 1143 Cleveland to Dallas/Fort Worth on October 13 (the flight route was Cleveland to Dallas Fort Worth and landed at 8:16 p.m. CT) to call 1 800-CDC INFO (1 800 232-4636). After 1 p.m. ET, public health professionals will begin interviewing passengers about the flight, answering their questions, and arranging follow up. Individuals who are determined to be at any potential risk will be actively monitored.

The healthcare worker exhibited no signs or symptoms of illness while on flight 1143, according to the crew. Frontier is working closely with CDC to identify and notify passengers who may have traveled on flight 1143 on Oct. 13.  Passengers who may have traveled on flight 1143 should contact CDC at 1 800-CDC INFO (1 800 232-4636).

 

Frontier Airlines Statement

 “At approximately 1:00 a.m. MT on October 15, Frontier was notified by the CDC that a customer traveling on Frontier Airlines flight 1143 Cleveland to Dallas/Fort Worth on Oct. 13 has since tested positive for the Ebola virus. The flight landed in Dallas/Fort Worth at 8:16 p.m. local and remained overnight at the airport having completed its flying for the day at which point the aircraft received a thorough cleaning per our normal procedures which is consistent with CDC guidelines prior to returning to service the next day. It was also cleaned again in Cleveland last night. Previously the customer had traveled from Dallas Fort Worth to Cleveland on Frontier flight 1142 on October 10.

Customer exhibited no symptoms or sign of illness while on flight 1143, according to the crew. Frontier responded immediately upon notification from the CDC by removing the aircraft from service and is working closely with CDC to identify and contact customers who may traveled on flight 1143.

Customers who may have traveled on either flight should contact CDC at 1 800 CDC-INFO.

The safety and security of our customers and employees is our primary concern. Frontier will continue to work closely with CDC and other governmental agencies to ensure proper protocols and procedures are being followed.”

Confirmed Case of Ebola Diagnosed in the United States

CNN is reporting that a patient in Dallas, Texas is the first person diagnosed with Ebola Virus in the United States.

According to the CDC, the patient traveled to the United States from Liberia on 9/19-9/20. The patient exhibited symptoms on 9/24, sought care on 9/26, and was admitted to the hospital on 9/28. Today, the CDC received and tested samples from the patient and confirmed the presence of the Ebola Virus by PCR methodologies.

The CDC and the Dallas County Health and Human Services will conduct contact interviews to determine if the patient may have had contact with anyone while infectious. If any contacts are identified, they will be quarantined and monitored for 21 days (the longest known incubation period for the virus).

CDC director Tom Frieden, MD, MPH says, “I have no doubt in my mind that we will stop it here.”

Be that as it may, it doesn’t hurt to be prepared. Lab professionals and pathologists should be familiar with the CDC’s Ebola information page.

CDC Update on the Ebola Outbreak

Yesterday Dr. Tom Frieden, Director of the Centers for Disease Control in Atlanta, briefed the media about the current Ebola outbreak in Africa and called for an immediate global response to the outbreak. “There’s nothing mysterious about what we need to do,” says Frieden. “The only real question is whether we’ll do it fast enough.”

Read the full transcript on the CDC website.

Read Maryn McKenna’s astute summary on the Superbug blog.