Abbott recently announced that the U.S. FDA has extended Emergency Use Authorization (EUA) for its 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. Quick and accurate diagnosis of Zika infection can help track the disease and potentially prevent the spread of the virus.
Recent reports indicate that the Zika virus is likely to stay. The virus is primarily spread to people through bites from infected mosquitoes. It but also be passed from pregnant women to their fetuses or through sex. According to Investopedia, as of February 8, 2017, up to 5,001 Zika cases have been diagnosed in the U.S.
The Abbott RealTime ZIKA test can detect the Zika virus 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. Providing results within five to seven hours, the test is highly sensitive to detect if someone is infected with Zika.
The test is designed for use on the m2000 RealTime System, Abbott's molecular diagnostics instrument used in hospitals and reference labs in the U.S. and around the world. As it is automated, it improves the efficiency of lab personnel, reduces the time spent preparing and handling samples, lessens the chances of error, and increases speed to diagnosis.
Abbott's goal with the test is to help clinicians make informed diagnoses for people infected with the virus.
"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. 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." said John Hackett, Ph.D., divisional vice president, applied research and technology, Diagnostics Products, Abbott.
The company's other R&D projects that address testing needs related to the current Zika outbreak include the U.S. Defense Advanced Research Projects Agency's (DARPA) contract to develop a testing panel for Zika and multiple tropical fever pathogens for use on a mobile platform to meet the needs of testing in rural and remote areas and a grant from the U.S. Agency for International Development (USAID) to Abbott to explore the development of a serology test to solve the Zika test challenge.