Abbott Molecular Receives EUA for Zika MDx
News Dec 03, 2016
Abbott has announced that its molecular test to detect Zika virus, the Abbott RealTime ZIKA test, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) 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.
According to the CDC, more than 4,000 people who live in the U.S. have been infected with Zika (primarily from travel outside the U.S.), and nearly 33,000 people are infected and reside in U.S. territories, mainly in Puerto Rico.1 Zika virus is primarily spread to people through bites from infected mosquitoes but can also be passed from pregnant women to their fetuses or through sexual transmission.2 It is important to quickly and accurately determine whether someone has a Zika infection to track and potentially help prevent the spread of the virus.
However, diagnosing and testing for Zika virus infection can be difficult. People who are infected with the Zika virus might not have any symptoms or only have mild symptoms that last a few days to a week.2 Molecular testing is recommended with urine in parallel with plasma or serum up to two weeks after a possible Zika infection.3
"Diagnosing a Zika infection can be challenging," said John Hackett, Ph.D., divisional vice president, applied research and technology, Diagnostics Products, Abbott. "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."
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. The test is highly sensitive, meaning that it can detect if people have an active Zika infection. 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 contamination and increasing speed to diagnosis.
Source: Story from Abbott Molecular. Please note: The content above may have been edited to ensure it is in keeping with Technology Networks' style and length guidelines.