The Food and Drug Administration has approved the first U.S. test to diagnose the Zika virus, according to an FDA release.
Quest Diagnostics has been granted an Emergency Use Authorization to sell the first commercial diagnostic test for the detection of the Zika virus. Quest plans to make the new test broadly available to physicians — including those in Puerto Rico — early the week of May 2, according to a Quest Diagnostics press release.
“The AHA is supportive of FDA efforts to approve new diagnostic tests and tools to help detect and diagnose Zika virus infection,” says John Combes, M.D., the American Hospital Association’s chief medical officer.
What health care providers should know about the test, according to the FDA:
- The test is intended for the in vitro qualitative detection of Zika virus RNA in human serum specimens with specified instruments.
- Zika virus RNA may be detected in serum for approximately four to seven days following onset of symptoms; the optimum time to perform testing is during the first week after the onset of clinical illness.
- Testing should be conducted only on specimens from individuals meeting Centers for Disease Control and Prevention Zika clinical and epidemiological criteria for testing.