April 2, 2020—BD and BioMedomics, a privately held, North Carolina–based clinical diagnostics company, announced the release of a point-of-care test that can detect, in as few as 15 minutes, antibodies in blood to confirm current or past exposure to COVID-19. The test analyzes blood, serum, or plasma samples for the presence of immunoglobulin M and immunoglobulin G antibodies associated with SARS-CoV-2.
“BioMedomics designed the test to be easy to use and provide results in minutes, with no special equipment necessary or the need to transport the sample to a laboratory for analysis,” Frank Wang, CEO of BioMedomics, said in a press release. “Our test has been clinically validated at several hospitals and clinical laboratories in both the U.S. and China, and our published clinical data in the Journal of Medical Virology was one of the world’s first for a COVID-19 serology test. It has been used widely in China during the COVID-19 outbreak and is now ready to help combat coronavirus in the U.S. through our collaboration with BD.”
The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance issued by FDA on March 16, and BD expects to begin shipping tests this month. BD will have capacity to supply more than one million tests over the coming months, with the ability to scale up based on market demand. Health care providers can order the test and all collection devices needed to perform the test by contacting BD or Henry Schein.