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FDA Gives Emergency Approval for New Zika Test
May 2nd, 2016
By Gary Evans, Senior Staff Writer, AHC Media
More widespread testing for Zika virus is now available, as the Food and Drug Administration has issued an Emergency Use Authorization (EUA) for a Qualitative Real-Time RT-PCR test.
Developed by Focus Diagnostics Inc. (a subsidiary of Quest Diagnostics in Madison, NJ), the test will detect Zika virus RNA in blood samples. The test should only be used for individuals meeting Centers for Disease Control and Prevention Zika virus clinical criteria (e.g., clinical signs and symptoms associated with infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission) by qualified laboratories designated by Focus Diagnostics, Inc, the FDA emphasized.
The EUA does not indicate formal FDA approval indefinitely, and can expire or be terminated or revoked by the department of Health and Human Services’ (HHS). As of April 27, 2016, U.S. public health officials were reporting 426 cases of Zika in the U.S.
According to a fact sheet posted by the FDA, all of the cases have either a recent travel history to areas with ongoing transmission or an epidemiologic link with an individual with such a travel history (i.e., through maternal-fetal or sexual transmission). Zika transmission is occurring in 35 countries and territories in the Americas, seven countries and territories in Oceania/Pacific Islands, and one country in Africa
"Public health officials have determined that Zika virus poses a potential public health emergency," the FDA states.
If Zika virus infection is suspected based on current clinical and epidemiological criteria, the RT-PCR test may be ordered. As chikungunya and dengue infection can have early symptoms resembling those of Zika infection -- and co-infection with these viruses is possible -- testing for those viruses should be considered as well. Zika virus RNA is typically detectable in serum for approximately seven days following onset of symptoms. Contact your state or local health department to facilitate testing, the FDA fact sheet states.