Abbott has received emergency use authorization (EUA) from the FDA for its molecular test for the identification of SARS-CoV-2, the virus that causes COVID-19.
The company is deploying 150,000 laboratory tests immediately. Tests already have been sent to hospital and academic medical center labs in 18 states including Illinois, California, New York, Massachusetts and Washington. Abbott is scaling up production at its U.S. manufacturing location to reach capacity for one million tests per week by end of March.
The Abbott RealTime SARS-CoV-2 EUA test can be used on Abbott’s molecular instrument, the m2000 RealTime system, by authorized laboratories in the U.S. These lab instruments, which test for a broad array of infectious diseases and are found in health systems across the U.S., can now have access to a SARS-CoV-2 assay to help healthcare providers deal with the high demand for testing.
Testing for an emerging virus at the molecular level
Molecular testing technology helps detect the presence of an infection. The tests are designed to identify the virus by targeting small amounts of it and amplifying that portion until there’s enough for detection.
“Our scientists, many of whom worked on Abbott’s first HIV test and the Zika tests, worked around the clock to develop these molecular tests,” said Daman Kowalski, vice president and head of, Molecular Diagnostics, Abbott. “Providing people at the frontlines of this pandemic with critical tests will help ensure proper care for patients and help protect our communities.”
Abbott will be working with health systems and government authorities to deploy additional m2000 systems where they are needed.
“Diagnostic testing is at the heart of the solution for any infectious disease outbreak because it can help prevent the spread of a virus,” said Christian Bréchot, MD, Ph.D., president of the Global Virus Network and a professor at the University of South Florida. “In the case of novel coronavirus, having technology that can be deployed to the frontline will make a real difference in the effort to stop the spread of this virus — something we are all working together to achieve.”