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.  

The Aftermath of Ebola

The Ebola outbreak may no longer make front page news in the United States and Liberia may have been declared Ebola free in May, but the consequences of the outbreak are still ever present, and will be for years to come.

The first reported Ebola case was in December 2013 in Guinea. By June of 2014 the outbreak had rapidly spread and the rest of the world was taking note. In May 2015 Liberia was declared Ebola free. Currently, the situation in Guinea and Sierra Leone is improving and each country is now able (from a health care standpoint) to isolate and treat current patients. However, new cases are still being reported in both countries so continued vigilance is paramount.

As the disease itself abates and it is possible to see the light at the end of the tunnel, it is clear that Ebola may be (nearly) gone, but its effects will linger for decades and it has left devastation in its wake.

The CDC estimates that, in the hardest hit countries of Guinea, Liberia, and Sierra Leone, the death toll from Ebola cases is: Guinea: 2,509, Liberia: 4,806, Sierra Leone: 3,947. The total number of cases is hard to track but estimates of total cases, including those that are suspected, probable, and confirmed are as high as 3,784 in Guinea, 10,666 in Liberia, and 13,241 in Sierra Leone (numbers are as of July 17, 2015).

The socio economic consequences of the outbreak are numerous.  Much of the day-to-day workings of the economy ground to a halt as people stayed home or fled jobs in factories, mines, and fields. Panicked investors fled as the disease began to spread. Disruption during the agricultural season caused diminished agricultural yields which had both economic consequences and resulted in severe food insecurity across the region. Internal and regional trade were dramatically affected due to boarder closures and movement restrictions to help staunch the transmission of the disease. Those who survived the outbreak are now left to pick of the pieces of their daily lives and learn to live without loved ones. Parents were left without children, children were left without parents. The courage it would take to find jobs, housing, a support system after watching loved ones die (and possibly being sick oneself) is hard to fathom.

A portion of the damage left in Ebola’s wake includes health care systems and infrastructure. Already weak to begin with, Ebola wreaked havoc on the human and infrastructural health care resources in all three countries. The Economist reports that an estimated 509 health care workers died in Guinea, Liberia, and Sierra Leone. This is an enormous loss of human resources in countries where, before the outbreak, the average doctor to patient ratio was less than 10 doctors per 100,000 people. Looking to the future, one of the biggest health care concerns is the number of children who went unvaccinated during the height of the outbreak. Because of this, vaccine-preventable diseases, such as measles and polio, will contribute, indirectly, to Ebola’s death toll.

To end on a positive note, however, the local and international communities are now left with an opportunity: to remake the systems better than they were before. In many places physical infrastructure, human resources, and other necessary systems will be starting anew. With the right expertise and resources, using best practices and with cooperation among international agencies, private donors, and local governments, among others, health care can be built stronger than before with an eye toward preventing such devastating outbreaks in the future and caring for the day-to-day health needs of the local populations.

For further reading:

Levy

-Marie Levy spent over five years working at American Society for Clinical Pathology in the Global Outreach department.

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.

Significant, but Fragile, Gains In the Fight Against Malaria

Marie Levy

January 2015 Lablogatory post

In recent months it seems that the only news stories about sub-Saharan Africa presented by western media are about Ebola. There are some bright spots in that news, but in general it is scary and saddening. Lost in the Ebola shuffle, however, is some good news about the fight against malaria. A recently released report from the WHO Global Malaria Programme states that worldwide the malarial mortality rate fell by 47% between 2000 and 2013 and currently 55 countries are on track to reduce their malarial burden by 75% by 2015. Those are exciting numbers. The report attributes these improvements to increased use of insecticide treated bed nets, accurate diagnostic testing, and increasingly effective drug therapies.

Accurate diagnostic testing means that the lab is playing a crucial role in the fight against malaria. Data from 2013 shows an increase in the use of diagnostic tests in sub-Saharan Africa. This supports additional data that shows there has been a shift from presumptive treatment to diagnostic treatment.

As a public health community, however, we cannot become complacent. The WHO report states that, in Africa, over 43,000 children die from malaria each year, 15 million pregnant women do not have access to preventative treatment, and over 200 million people live in households without access to insecticide treated bed nets.   Drug and insecticide resistance is a serious concern (thus underscoring the importance of accurate diagnostic testing to prevent presumptive treatment that can contribute to drug resistance). In the West African countries hit by the Ebola outbreak, health care resources have all been directed towards the fight against Ebola leaving them vulnerable to increases in other disease occurrence. If nothing else, however, the Ebola outbreak has provided a reason and impetus for discussions surrounding the importance of health systems strengthening. Strengthening that will not only fight future outbreaks of diseases such as Ebola, but will improve health care networks for every day care and treatment.

Thus, in the spirit of the holidays, let’s celebrate this good news. But while doing so, let’s also continue the fight and keep up the good work.

Links for further reading:

http://apps.who.int/iris/bitstream/10665/144852/2/9789241564830_eng.pdf

http://www.nytimes.com/2014/12/14/opinion/sunday/fragile-gains-against-malaria.html?_r=0

http://kff.org/news-summary/significant-global-gains-made-against-malaria-but-ebola-threatens-progress-in-west-africa-who-report-says/

Levy

-Marie Levy spent over five years working at American Society for Clinical Pathology in the Global Outreach department.

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.”