The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Bodysphere’s Covid-19 IgG/IgM Rapid Test Cassette that diagnoses the coronavirus (Covid-19).
The test has a 91% clinical specificity rate and a 99% clinical sensitivity rate and uses antibodies in blood to identify current or past coronavirus infection.
It uses lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) associated with Covid-19 in human whole blood, serum or plasma. The results are delivered onsite within two minutes.
Furthermore, the test can be administered as easy as a glucose test.
Bodysphere CEO Charlton Lui said: “When we realised we had the ability to step up and fight this pandemic at a critical point, we focused all our resources on bringing the rapid test kits, masks and other critical supplies to the frontlines as soon as possible.
“Thankfully, when our perpetual quest for improving health put us in a position to deliver this lifesaving product, it became quite clear what we had to do.”
The company noted that the test has been used in several states where large launches are planned to mitigate Covid-19 outbreak.
Bodysphere is currently in talks with federal agencies and states to immediately deploy test kits to hospitals, as well as urgent care and emergency rooms across the country.
Bodysphere has also contracted cargo planes to deliver the product to the frontlines faster. Five million test kits are expected to be delivered in the next few weeks.