WHO plans to speed development of Ebola rapid test

DNA test at mobile Navy lab
DNA test at mobile Navy lab

A Navy worker extracts RNA from a patient sample at a Naval mobile lab in Liberia., US Army Africa

Quicker and simpler diagnostic tests for Ebola could go a long way in helping break chains of disease transmission in West Africa's outbreak region, the World Health Organization (WHO) said today, as it unveiled two new initiatives to expedite their development.

The WHO said it hopes new efforts—similar to those under way to test and deliver an Ebola vaccine—can compress the development of a rapid test in months instead of years.

Initiatives to speed development and evaluation

Standard reverse-transcriptase polymerase chain reaction (RT-PCR) tests used in mobile and other labs in the outbreak are very accurate when conducted by trained staff, but they require a full tube of blood, take 2 to 6 hours to get a result, and costs around $100 per test, the WHO said today in a statement.

Though the test is a key tool for aggressive case detection and isolation, as well as a guide for clinical decisions, the slow and complex nature of the process remains one of the outbreak response's main logistical challenges, the WHO said.

Building a strong case for the benefits of a quicker test, the WHO cited a Nov 5 New England Journal of Medicine report suggesting that quicker diagnostics could significantly improve clinical outcomes.

The WHO also said having a rapid test for Ebola could help stabilize fragile health systems and be useful in the wider African region, which faces other diseases with symptoms that mimic Ebola.

The first initiative is designed to minimize barriers for companies that are developing tests, the WHO said. It defines the needs of the test and streamlines access to early validation materials and clinical samples. It would also pave the way for deploying the new test in the field. The collaboration would include manufacturers, researchers, staff from Doctors without Borders (MSF), and the nonprofit group Foundation for Innovative New Diagnostics (FIND).

Ideally, the test could be used in a peripheral clinic with no lab infrastructure in place, produce a result in 30 minutes, and have no biosafety requirement other than wearing personal protective equipment (PPE). Training staff to use the test should take less than a day, and the supplies should be easy to store and reconstitute, the WHO added.

The WHO said the second initiative is aimed at putting in place an emergency assessment mechanism for new diagnostic tests for Ebola. In October it invited companies working on tests to submit initial documentation, and the WHO received 16 submissions as of the middle of October. They range from conventional tests to point-of-care tests that could detect Ebola with blood from a finger prick.

An expert group using the quality assessment mechanism is now reviewing five of the submissions, with the overall goal of getting the best new tests to West Africa within the next few months, the WHO said. It added that progress and priorities on diagnostic test development will be discussed at a WHO expert consultation meeting in Geneva in December.

Outbreak region updates

In a radio address 2 days ago, Liberia's President Ellen Johnson Sirleaf said the country's new goal is having zero new cases of Ebola by Christmas, according to an update yesterday from the United Nations Mission for Ebola Emergency Response (UNMEER). She also announced changes to her cabinet, naming a new health minister, George Werner, to replace Walter Gwenigale.

Liberia has had a downturn in cases in some of the key outbreak areas, including the capital, but the disease has spread to newer and more remote areas. Experts have warned that the disease could flare again in Liberia as it has in Guinea.

According to UNMEER, the Ebola response was the topic of a G-20 leaders meeting in Brisbane that concluded on Nov 16 and resulted in a pledge to do whatever is necessary to help battle the Ebola outbreak.

Leaders urged countries that haven't contributed to the battle against the disease to assist with financial aid, medical staff, equipment, and medicine. They also called on the World Bank and the International Monetary Fund (IMF) to continue their strong support of the hardest-hit nations and lauded an IMP plan to free up $300 million for outbreak needs and to ease the burden on Guinea, Liberia, and Sierra Leone.

In a related development, the European Commission (EC) yesterday announced $15 million more to help with the outbreak response. The new funding is targeted to the transportation of materials, evacuation of infected health workers, health worker training, and assistance to neighboring countries to help them prepare.

The announcement came after two of the EC's top officials toured Guinea, Liberia, and Sierra Leone. The new funding brings the EC's total commitment so far to $466 million and the European Union's total contribution to nearly $1.37 billion.

The EC also said in the statement that Sweden will send 42 health workers to West Africa.

Other developments

  • If Ebola infection rates continue dropping in Liberia, it could complicate plans for a clinical trial of two experimental vaccines, which may start as soon as January, according to a report in Scientific American today. Plans call for enrolling 27,000 participants in the trial. The story says that vaccine trials work best in settings where the targeted pathogen is spreading. "If infection rates drop too low, the planned Liberian trial . . . would have to be expanded, adding to the cost, complexity and the time it will take to get to the answers," it says. Trial planners hope to avoid that, said Charles Link Jr., CEO of NewLink Genetics, an Iowa-based biotech that is developing one of the vaccines. "I don't think anybody wants to go in that direction. I think they want to chase the spots where the infection is just more rampant," he said.

  • MSF said yesterday that an unrelated outbreak that began in the Democratic Republic of the Congo (DRC) is now under control and that it is withdrawing its teams from the affected area. The last case was confirmed on Oct 4, and MSF had deployed 70 staff to the region. It said it would continue to monitor the situation and ensure that local authorities have the capacity to respond to any other infections. According to the WHO's most recent update, the DRC's outbreak resulted in 66 cases, 49 of them fatal.

  • New York Senator Charles Schumer yesterday called on the federal government to reimburse New York City for the $20 million it spent to quarantine and treat Craig Spencer, MD, who was exposed to Ebola while working in West Africa and was hospitalized at Bellevue Hospital. In a statement, Schumer said the $20 million includes contact tracing and covers about 100 health workers who were involved in Spencer's care and a 24-hour-a-day operation by the city to monitor about 300 people who returned from the region or who had contact with the sick doctor.

  • In a separate development, an official from Nebraska Medical Center said today that it cost about $1.16 million to treat the facility's first two Ebola patients. Jeffrey Gold, MD, the hospital's chancellor, said in prepared testimony from a House Energy and Commerce oversight subcommittee hearing that it's not clear who will pay the bill and how. Gold and Schumer both urged Congress to consider a contingency fund to reimburse hospitals for the unique cases.

News editor Robert Roos contributed to this report.

See also:

Nov 18 WHO statement

Nov 5 N Engl J Med report

Nov 17 UNMEER update

Nov 15 G-20 Ebola pledge

Nov 17 EC press release

Nov 17 Scientific American story

Nov 17 MSF statement

Nov 17 Sen Schumer press release

Nov 18 Gold testimony

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