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FDA grants Abbott EUA for molecular Zika test

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Feb. 14, 2017—The FDA has authorized Abbott’s molecular RealTime Zika test to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for emergency use.

“Diagnosing a Zika infection can be challenging, especially since people might not have any symptoms or only have mild symptoms that last a few days,” John Hackett, PhD, Abbott’s divisional vice president, applied research and technology, Diagnostics Products, said in a statement. “Abbott’s molecular test may provide the ability to identify the active virus over a longer time period with whole blood and could provide a more accurate diagnosis. Our test can also distinguish Zika from other viruses such as dengue or chikungunya, which helps doctors make informed diagnoses to help people get back to better health.”

The RealTime Zika test is designed for use on the m2000 RealTime system, Abbott’s molecular diagnostics instrument. Providing results within five to seven hours, the test is highly sensitive to detect if someone is infected with Zika. It is also automated, allowing people who work in the lab to be more efficient and spend less time preparing and handling samples, reducing the chances of error and increasing speed to diagnosis.

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