FDA approves two-minute novel coronavirus antibody testing kit – SlashGear
The Food and Drug Administration has approved a coronavirus testing kit from Bodysphere, one that can detect antibodies related to the virus in only two minutes. The test will be deployed in states around the country, enabling healthcare facilities to test for signs that the patient had contracted the virus at some point. The testing kit is only intended for use by medical professionals, however.
The FDA’s Emergency Use Authorization was given to Bodysphere for its COVID-19 IgG/IgM Rapid Test, which is a lateral flow immunoassay that can look for COVID-19 virus antibodies in the blood, plasma, and serum, according to the company. The benefit of an antibody test is that it can be used to determine whether someone previously contracted COVID-19, but then recovered from it without any testing at that time.
The test takes between two and 10 minutes to return results, according to Bodysphere, which explains that its testing kit doesn’t require lab equipment or extensive staff training. Put simply, Bodysphere says its antibodies test is as simple as a blood glucose test, though consumers won’t get direct access to the testing kits.
Thus far, the Bodysphere testing kit has been put to successful use in multiple states; the company is working with state and federal health officials to expand the availability of its testing kit to hospitals and urgent care facilities. It will only take ‘weeks’ to get millions of these testing kits deployed through the United States.
In a statement, Bodysphere CEO 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. 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.