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FDA Gives Emergency Approval to Zika Test

(CN) — The Federal Drug Administration on Friday issued an emergency-use authorization of the first commercial test for the Zika virus.

The mosquito-borne virus has spread rapidly throughout the Caribbean and Latin America. Health officials have warned that local transmission within the continental United States could occur.

The test's developers, Quest Diagnostics, say the diagnostic tool will be available in the United States and Puerto Rico as soon as next week. Puerto Rico has been particularly hard-hit by Zika, with more than 600 residents testing positive for the virus.

The only existing method for determining if a person is infected with Zika is through a network of laboratories approved by the Centers for Disease Control and Prevention. U.S. residents have reported difficulty getting approved for testing, and results can take up to three weeks.

"The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak," Rick Pesano, vice president of research and development for Quest Diagnostics, said in a statement on Thursday.

The test uses a process known as real-time RT-PCR to determine if a person is infected with Zika, using blood samples. However, a negative test does not necessarily mean the virus is not in a patient's body.

Instead, it can be used in conjunction with antibody tests and other methods for determining if the virus is present in a person's body. The CDC currently offers Zika antibody tests.

Samples will be analyzed by trained personnel at Quest's subsidiary, Focus Diagnostics. All cases of Zika must be reported to the CDC for surveillance purposes.

The CDC recommends testing for anyone who experiences Zika-like symptoms after traveling to areas with active local transmission within the past two weeks. Pregnant women who visited or lived in affected regions are also advised to get tested.

Males who have visited or lived in areas with active transmission should also be tested since the virus is transmitted sexually.

The CDC has confirmed that Zika can lead to a series of birth defects including microcephaly, a congenital disorder that leads to babies being born with reduced head size and potential brain damage.

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