FDA grants emergency clearance for Zika diagnostic tool

FDA has issued emergency clearance for Trioplex Real-time RT-PCR assay, a diagnostic tool for the Zika virus. The CDC will distribute the test to qualified laboratories that respond to public health emergencies over the next two weeks. It will not be available in hospitals or other primary care settings. Officials have warned that spring breaks in places such as the Caribbean could lead to the virus spreading further.  The news comes as the first case of the Zika virus has been identified in Connecticut, in an American patient who had travelled to the Philippines before taking ill.

A new real-time 3-in-1 Zika virus test was given the green light from the US Food and Drug Administration and is to be shipped to labs across the country within coming weeks. However, it will not be available in US hospitals.

The Trioplex Real-time RT-PCR Assay is a breakthrough diagnostic tool, which is capable of also revealing chikungunya and dengue as well as Zika in just one test, instead of three separate exams.

The FDA granted its emergency approval to the new lab test on Thursday, the Centers for Disease Control and Prevention said.

The CDC is going to start distributing the test during the next two weeks only to qualified laboratories, included in the Laboratory Response Network, which respond to public health emergencies.

At least 14 new cases of 'possible sexual transmission' of Zika virus – CDC https://t.co/ljQrYGMe5kpic.twitter.com/0hsVSLKzlP — RT America (@RT_America) February 24, 2016

The test will not, however, be available in hospitals or other primary care settings.

According to the CDC’s latest stats, at least 258 Americans have contracted mosquito-borne Zika while traveling abroad, including 18 pregnant women.

The Zika virus has been reported as being transmitted by mosquito bite in Puerto Rico and the US Virgin Islands, but in the continental United States cases have only been contracted by people traveling abroad or by sexual contact with people who have traveled outside the US.

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Last week, officials warned that spring breaks in places like Mexico or the Caribbean can lead to Zika spreading even further.

“It is possible to bring Zika home back into the United States,” said Vinny Taneja, Public Health Director for Tarrant County in north Texas. “And after spring break, I mean, we’ve got thousands and thousands of people visiting all over the place, so that can happen.”

In late-February, two hospitals in Houston, Texas, developed a rapid test for Zika as the world’s health community is seeking ways to target the virus.

Spring breakers could cause Zika outbreak, health officials warnhttps://t.co/ycHf1LdutQpic.twitter.com/4j8Kjoo4vT — RT America (@RT_America) March 11, 2016

According to the CDC, there is no commercially available test for Zika virus. Currently, testing is performed in the US at the CDC and four state health department laboratories.