BODYSPHERE announced today they are distributing a new Two-Minute Testing Kit for the diagnosis of the COVID-19 following the U.S. Food and Drug Administration (FDA) Emergency Use Authorization for the test which uses antibodies in blood to test for current or past infection.
The following statement was denied by the FDA confirmation that no such test had been authorized at the time. On Wednesday, the company acknowledged that the test had not in fact received the authorization
The tests have a 91,81% relative specificity rate and a 84,91% relative sensitivity rate. Results are delivered on site in as fast as two minutes. This is a game changer as today in the United States, most COVID-19 testing results take between two to seven days.
The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) for the Novel coronavirus in human whole blood/serum/plasma. The test can be administered as easy as a glucose test but is designed strictly for use by medical professionals.
“When we realized 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 front lines as soon as possible.” said Charlton E. Lui, Chief Executive Officer of BODYSPHERE. Lui continued, “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 test kits have been used successfully in several states where large roll outs are planned to combat the spread of the virus. BODYSPHERE is working closely with federal agencies and states to quickly deploy test kits across the country to hospitals, urgent care and emergency rooms. The company has already contracted cargo planes to deliver the product to the front lines faster. BODYSPHERE is positioned to have millions of test kits on the front lines in weeks.
Lui added, “At BODYSPHERE, we understand and have built an infrastructure to tackle some of the most daunting issues the world has faced; be it climate change, our ecosystem, pollution, public health concerns and the opioid crisis.”