The new diagnostic test, with 91% clinical specificity rate and a 99% clinical sensitivity rate, has been designed to use antibodies in blood to test for current or past infection
FDA grants EUA for Bodysphere’s new COVID-19 test kit. (Credit: Pixabay/Ahmad Ardity)
Bodysphere has secured the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its new testing kit to diagnose the novel coronavirus (COVID-19) within two minutes.
The new diagnostic test, with 91% clinical specificity rate and a 99% clinical sensitivity rate, has been designed to use antibodies in blood to test for current or past infection.
Bodysphere chief executive officer Charlton E Lui said: “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.”
BodySphere has partnered with federal agencies to deploy its new diagnostic test kits
According to the company, most of the COVID-19 testing results in the US would take between two to seven days, while its new diagnostic test would deliver results quickly within two minutes.
The company has developed the new COVID-19 IgG/IgM rapid test cassette as a lateral flow chromatographic immunoassay, to detect novel coronavirus antibodies in human blood or serum or plasma.
In addition, the test can be administered easily, similar to a glucose test.
BodySphere claimed that it is working together with federal agencies and states to advance the installation of test kits across hospitals, urgent care and emergency rooms in the country.
In addition, the company has already contracted cargo planes for faster delivery of the product to the front lines, with an aim to distribute millions of test kits on the front lines in weeks.
Lui added: “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. 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.”
Recently, Luminex has obtained the EUA for its NxTAG CoV extended panel, a test intended for the detection of the SARS-CoV-2 virus.
Designed for use with the company’s compact MAGPIX System, the test enables advanced molecular laboratories to rapidly detect SARS-CoV-2 virus in up to 96 patients in approximately 4 hours.