FDA Grants Emergency Use Authorization for Ebola Diagnostic Test
The FDA recently granted Emergency Use Authorization for the Idylla Ebola Virus Triage Test, a diagnostic test which detects the presence of the virus in blood.
The US Food and Drug Administration (FDA) recently granted Emergency Use Authorization (EUA) for the Idylla Ebola Virus Triage Test (Idylla EBOV Test), a diagnostic test which detects the presence of the virus in blood.
According to a press release, the test is a collaborative effort between Janssen Diagnostics, Biocartis, and the Belgium Institute of Tropical Medicines. The Idylla EBOV Test uses a real-time reverse transcript polymerase chain reaction (rRT-PCR) to qualitatively detect Ebola Zaire virus RNA, the same strain that caused fatal outbreaks in West Africa in 2014, in EDTA whole blood samples.
Results from the Idylla EBOV Test are available after approximately 100 minutes. This test is highly standardized and does not require cold chain reagent storage, according to the press release. Suspected cases should only be tested using the Idylla tests if they show signs and symptoms of the Ebola virus, or epidemiological risk factors.
The Centers for Disease Control and Prevention (CDC) classifies epidemiological risk factors for Ebola virus into four categories. Risk assessment is generally established on whether or not the individual was wearing proper personal protective equipment when coming in contact with an infected person or contaminated blood or other bodily fluids. More information can be found on the CDC website under: Epidemiologic Risk Factors to Consider when Evaluating a Person for Exposure to Ebola Virus.
An Ebola virus diagnosis should not be made on the basis of this test alone, but should incorporate the patient’s history, signs and symptoms, likelihood of exposure, and other laboratory evidence. Healthcare practitioners should be aware that public health authorities, including local, state, and national agencies, must be notified of any suspected Ebola virus disease cases.
The Idylla EBOV Test was evaluated with a limited number of specimens infected with live RNA from that viral strain, since obtaining clinical specimens of Ebola-infected blood is difficult. Since the test is only to be used under Emergency Use Authorization, only laboratories that are US-certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a, to perform moderate complexity tests or to perform high complexity tests, as well as non-US laboratories which have similar qualifications, may perform the test. In addition, laboratory personnel must receive specific training before using the Idylla EBOV Test.
Speaking about the test, the Chief Medical Officer of Janssen Diagnostics, a division of Janssen Pharmaceutica and a Johnson & Johnson affiliate, Jorge Villacian, MD, stated, “We are very pleased that the FDA has granted Emergency Use Authorization for the Idylla Ebola Virus Triage Test… Across Johnson & Johnson, we are mobilizing our resources and expertise to help prevent another outbreak of Ebola.”
Since the discovery of the Ebola virus 40 years ago, the 2014 outbreak in West Africa was the largest outbreak observed, causing more than 11,000 total deaths. Although the three countries which experienced severe active transmission of Ebola virus, Guinea, Liberia, and Sierra Leone, have all declared their outbreaks to be over, experts believe that there will be sporadic cases across the region in the future, further solidifying the need for an Ebola diagnostic test.