New DRC Ebola cases confirmed as FDA OKs rapid test

The World Health Organization (WHO) tracked 2 new Ebola cases in the Democratic Republic of the Congo (DRC) today on its outbreak dashboard, lifting the outbreak total to 3,210 cases, including 2,146 deaths. Officials are still investigating 421 suspected cases.

The news comes as the US Food and Drug Administration (FDA) approved its first Ebola rapid diagnostic test.

The new cases are likely part of the "trickle" that Mike Ryan, MD, the WHO's executive director of health emergencies, said was to be expected as transmission slows and the outbreak shrinks to a small region that straddles North Kivu and Ituri provinces.

Ryan made those comments yesterday during a press conference that, for the most part, presented encouraging data. In recent weeks, new cases have declined, with only single cases confirmed on several days in the past week.

The Ebola outbreak will be declared over when 42 days, or two 21-day transmission cycles, pass with no new cases.

Progress tinged with caution

In its latest disease outbreak news update, the WHO echoed Ryan's remarks.

"There is a shift in hot spots from urban settings to more rural, hard-to-reach communities, across a more concentrated geographical area," the WHO said, noting that 14 cases had been recorded from Sep 30 to Oct 6.

Since September, almost four of five confirmed cases have come from four health zones: Mandima (31%), Mambasa (29%), Komanda (10%,), and Oicha (8%). Today, the DRC's Ebola technical committee (CMRE) said the single case reported yesterday was in Lolwa.

As reported earlier, the WHO said response activities resumed in Lwemba this past week, after security incidents in mid-September halted all activity for more than 2 weeks.

"Response activities have since resumed but remain limited. Improved access may result in enhanced case finding and contact tracing therefore could result in an increase in the number of reported cases and contacts in the area," the WHO said.

The WHO also warned that the recent decline in cases should be interpreted cautiously. "The situation remains highly contingent upon the level of access and security," the WHO said.

New rapid Ebola test OK'd to sell

Yesterday the FDA allowed for marketing a new rapid diagnostic test for Ebola, the OraQuick Ebola Rapid Antigen Test. This is the first rapid Ebola test approved for sale in the United States, the FDA said in a news release.

"The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving," said Acting FDA Commissioner Ned Sharpless, MD. "Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials."

OraQuick provides a presumptive diagnosis that must be confirmed, the FDA said. The test was developed during the 2014-2016 West African outbreak and is meant to be used on symptomatic patients and in recently deceased patients with suspected Ebola.

The test was made available during the West Africa outbreak and subsequent DRC outbreaks via the FDA's Emergency Use Authorization pathway.

See also:

WHO Ebola dashboard

Oct 10 DRC CMRE update

Oct 10 WHO disease outbreak news

Oct 10 FDA press release

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