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FDA authorizes first commercial Zika test for emergency use
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The first commercial blood test for Zika virus will be available in the United States and Puerto Rico early next week after being approved for emergency use by the FDA, according to the test’s manufacturer.
The Zika Virus RNA Qualitative Real-Time RT-PCR test (Quest Diagnostics) — designed for the qualitative detection of Zika virus RNA in human blood — has been granted an emergency use authorization (EUA) by the FDA, Quest said in a news release.
Figure 1. A female Aedes aegypti mosquito, the main vector of Zika virus, as it feeds on human blood.
Source: James Gathany, CDC
“The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak,” Rick L. Pesano, MD, PhD, vice president of research and development at Quest, said in the release.
The test is intended only for patients who qualify under CDC clinical or epidemiological criteria for Zika virus. Quest said its Focus Diagnostics laboratory in San Juan Capistrano, California, which developed and validated the test, will handle testing for the U.S. and Puerto Rico under the current demand.
The FDA previously had only granted EUAs for Zika tests to the CDC for use in qualified public health laboratories.
As of April 27, there were 426 reported cases of Zika in the U.S. — all related to patients who had traveled to a place where the virus is endemic. In U.S. territories, however, including hard-hit Puerto Rico, 596 of the 599 reported cases as of April 27 were locally acquired.
The CDC has confirmed that Zika virus infection during pregnancy can cause microcephaly and other serious birth defects.