Abbott announced Thursday that the U.S. Food and Drug Administration (FDA) has authorized its molecular test, the Abbott RealTime ZIKA test, to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for emergency use.
This is the first molecular test made by a commercial manufacturer authorized to detect Zika in whole blood samples, which is significant since recent research suggests Zika virus can be detected in whole blood for a longer period of time (up to two months) and at higher levels versus testing with serum and urine sample types.
“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,” said John Hackett, Ph.D., divisional vice president, applied research and technology, Diagnostics Products, Abbott. “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 Abbott RealTime ZIKA test is designed for use on the m2000 RealTime System – the company’s molecular diagnostics instrument used in hospital and reference labs in the U.S. and around the world. 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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