FDA OKs Abbott's whole-blood Zika test for emergency use

Previously authorized to detect Zika in plasma, serum and urine in emergency situations, Abbott's test is the first to gain authorization to detect the virus in whole blood.

The FDA authorized Abbott’s molecular test to screen for Zika virus in whole blood for emergency situations. It was previously cleared for emergency use in detecting the virus in serum, plasma and urine.

The new authorization comes after recent research showed that Zika virus can be detected in blood at higher levels and for longer than it can in serum, plasma and urine, according to a statement. The new findings differ from CDC guidelines, issued in May last year, which said that urine samples were better than blood samples for detecting the virus.

"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,” said John Hackett, divisional vice president of applied research and technology at Abbott’s Diagnostics Products unit. “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."


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The RealTime Zika test is used on Abbott’s m200 RealTime molecular diagnostics platform. It returns results within five to seven hours.

The FDA has authorized a number of Zika tests for emergency use—Quest Diagnostic’s tests for the virus in serum, while Roche’s screens for it in serum and plasma. Other players, including Siemens, ARUP Labs and Vela Diagnostics make a test that detects Zika in urine as well as serum.

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