According to Medical Device Daily, the US Food and Drug Administration (FDA) has authorized the emergency use of a diagnostic molecular test developed by Quest Diagnostics subsidiary, Focus Diagnostics Inc., in response to growing concerns over the recent Zika virus outbreak. According to the report, this is the first test from a commercial lab to receive emergency use authorization to test U.S. patients for the Zika virus. It could potentially significantly broaden the access of U.S. physicians to diagnose the virus, as previously Zika tests were limited to qualified CDC-designed laboratories. As a result, more patients can be screened and individuals with the disease can be identified earlier.
According to the FDA, Quest’s Zika Virus RNA Qualitative Real-Time RT-PCR test is intended for the qualitative detection of Zika virus RNA in human serum approximately 4-7 days following onset of symptoms, which include fever, joint pain, rash, or conjunctivitis. In particular, the CDC recommends testing for individuals with symptoms suggestive of Zika infection who have traveled within the last two weeks to an area with ongoing transmission, asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection, asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection, and infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy – including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.