FDA approves diagnostic test to stop spread of Ebola – EPM Magazine

OraSure Technologies has seen its OraQuick Ebola Rapid Antigen Test approved for use by the Food and Drug Administration (FDA).

The test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens from viruses within the Ebolavirus genus.

It is intended as an aid in the determination of Ebola virus disease (EVD) as the cause of death to inform decisions on safe handling of cadavers to prevent disease transmission. The FDA feels the test can help efforts to contain Ebola outbreaks by cutting the time it takes to diagnose patients and facilitate safe burials.

It is intended for use with venipuncture whole blood and fingerstick whole blood specimens as an aid in diagnosis of EVD in patients suspected of and with signs or symptoms consistent with EVD who have epidemiological risk factor(s) for Ebolavirus exposure (e.g., contact with a known or suspected case, travel to a geographic location at a time when Ebolavirus transmission was known or suspected to have occurred).

It is used with cadaveric oral fluid collected from recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD.

The test can allow providers to assess within 30 minutes whether a patient or recently deceased individual has been affected with the virus.

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