FDA Approves New Test Kit That Can Detect Coronavirus In 2 Minutes

The U.S. Food and Drug Administration (FDA) has approved the emergency use of a new two-minute testing kit for the diagnosis of COVID-19. On Monday, Bodysphere Inc., the manufacturer of the serological test kits, confirmed that the FDA had already given them the green light to deliver the kits to the front lines.

In recent weeks, the FDA has been scrambling to approve testing kits that promise quicker results. Last week, the agency granted Abbott Laboratories the authority to produce portable coronavirus testing kits that could detect the novel coronavirus within five minutes. The emergency authorization was a game changer, considering that the average wait time for a patient’s COVID-19 test results in the United States is about four to five days.

With the approval of the Bodysphere testing kits, COVID-19 can now be detected in two minutes. The testing kit is designed for use strictly by medical professionals and is administered like a glucose test. This kit will help determine whether health care workers have some immunity to the disease and are at higher or lower risk if they go back to work. It will also aid researchers in tracking the scale and death rate of COVID-19.

The Bodysphere test kits have a 91% clinical specificity rate and a 99% clinical sensitivity rate. Prior to its approval, the privately held company had successfully used this testing kit in several states where huge roll outs are planned to fight the spread of the novel coronavirus.

“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 Bodysphere chief executive officer Charlton E. Lui.

“Thankfully, when our perpetual quest for improving health put us in a position to deliver this life-saving product, it became quite clear what we had to do,” he added.

Currently, Bodysphere is working closely with federal agencies and states for the hasty deployment of the testing kits across country hospitals and emergency rooms. With contracted cargo planes set to deliver the product to the front lines in the coming days, millions of Bodysphere testing kits are expected to reach the front lines in weeks.