The Food and Drug Administration has expanded its emergency use authorization for an Abbott-developed molecular test for Zika virus detection to involve the use of whole blood in addition to previous serum and urine sample usage.
Abbott said Thursday the RealTime ZIKA test was created for use on the company’s molecular diagnostics instrument called the m2000 RealTime System which has been used in hospitals and reference labs around the world.
Some studies have suggested the Zika virus can be detected in whole blood for up to two months and can be tested at higher levels in comparison with serum and urine sample type testing, the company noted.
“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, divisional vice president of applied research and technology at Abbott’s diagnostics products business.
“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 [and] 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.
Abbott also works to develop a testing panel for Zika and other tropical fever pathogens for use on a mobile platform as well as a serology test that do not cross-react with other tropical disease antibodies under contracts with the Defense Advanced Research Projects Agency and the U.S. Agency for International Development.