FDA: Emergency Use Authorization for Rapid Ebola Test
Test offers results in about three hours
MONDAY, Dec. 29, 2014 (HealthDay News) -- The U.S. Food and Drug Administration has granted Emergency Use Authorization for Roche's fast-acting Ebola test for emergency use.
The authorization was issued for the LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as travel from West Africa. The test offers results in about three hours, compared to many tests on the market that can take a day to produce results, according to news reports.
It's hoped that the test can be used in the field to identify people infected with the strain of Ebola that has been causing devastation in West Africa since the spring. The test is still not approved for general use, the FDA said. By diagnosing Ebola early, the goal is to offer quicker treatment of patients who show signs of the disease.
However, the Washington Post reported Monday that the test probably won't have a significant impact on Ebola diagnoses -- at least initially. The reason: Many patients in West Africa live far from labs equipped with expensive testing techniques needed to interpret the results.