FDA grants EUA for Abbott RealTime Zika
Dec. 9, 2016—Abbott’s molecular test to detect Zika virus, the Abbott RealTime Zika test, received Emergency Use Authorization from the U.S. Food and Drug Administration for use by authorized laboratories. The test is authorized to detect Zika virus RNA in blood plasma and serum as well as urine samples (when collected alongside a patient-matched serum or plasma sample) and can provide results within five to seven hours.
“Abbott’s molecular test uses the CDC’s recommended sample types and can distinguish Zika from other viruses such as dengue or chikungunya, which helps doctors make informed diagnoses to help people get treated and get back to better health,” John Hackett, PhD, Abbott’s divisional vice president, applied research and technology, diagnostics products, said in a statement.
The RealTime Zika test is designed for use on the m2000 RealTime system, the company’s molecular diagnostics instrument, and is highly sensitive and automated.