FDA Approves Ebola Rapid Test

The FDA issued an emergency use authorization for an antigen rapid test (ReEBOV/Corgenix) to detect Ebola Zaire virus.

The value of the test is that it has a low rate of false positives and can detect the virus in people who do not yet show symptoms. It can be used as a finger-stick test and works with either whole blood, plasma, or serum from individuals suspected of being infected, usually because they have signs and symptoms or have been in an area with high rates of Ebola infection.

It is the only test approved by the FDA that can detect Ebola Zaire in clinical specimens, according to an FDA fact sheet released February 24, 2015.

The FDA said the test should be used in place of the more sensitive Ebola nucleic acid test when a more rapid test result is needed.

The test is only meant for individuals with symptoms or in other situations where there is a high chance that person in infected. It is not for general screening such as that being done at airports. It is also not intended for use in contact tracing.

In the fact sheet, the FDA warns practioners to use personal protective equipment in collected specimens for testing.

The test also comes with a caveat that a negative test does not necessarily mean the virus is not present, only that it was not present at the level needed to get a positive response.

False negatives are most likely in cases where the patient is known to have been exposed to the disease or has symptoms that look like Ebola infection. However, the test has a low rate of false positives, according to the FDA.

Patients who test positive should be quarantined even if they have no symptoms, the FDA said.

Corgenix is based in Broomfield, CO.