FDA Issues Emergency Use Authorization for First Commercial Zika Test

The world’s first commercial Zika test has been approved for Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

The FDA issued EUA for the RNA Qualitative Real-Time RT-PCR Zika virus test created by Quest Focus Diagnostics Inc., a subsidiary of Quest Diagnostics of Madison, New Jersey. This authorization will allow qualified labs in the United States (including Puerto Rico), certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and designated by the manufacturer, to test for Zika virus in human serum samples for those meeting the following Centers for Disease Control and Prevention (CDC) clinical or epidemiological criteria: presenting with signs and symptoms of the Zika virus; history of residence in or travel to areas with active Zika transmission. Previously, the only other Zika test that was FDA-approved for EUA was limited to labs designated by the CDC.

In a press release issued by Quest Diagnostics, Rick L. Pesano, MD, PhD, vice president of research and development, stated, “The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak.” The test will be available for commercial use in the United States and Puerto Rico on May 2, 2016; until then, only the Focus Diagnostics reference lab in San Juan Capistrano, California, where the test was developed, has access to use the test.

The CDC recommends pregnant women be tested for Zika after the first week of presenting with Zika-like symptoms, using an RT-PCR test. Since negative test results do not rule out infection, follow up serological testing should be considered after 2 to 12 weeks of symptom onset.

Even though the test received Emergency Use Authorization from the FDA, this does not mean it has been cleared or approved. All cases testing positive for Zika within the United States using this or any test must be reported to the CDC. Positive test results alone are not basis for diagnosis. A physician must also consider each case’s history, symptoms, likelihood of exposure (including residence in or travel to areas with active Zika transmission), and other lab evidence.