FDA Approves First At-Home Coronavirus Test
The dearth of testing put the US at a major disadvantage as the coronavirus pandemic began snowballing earlier this year. Even now, it can be tough to get a test unless you’re showing severe symptoms of COVID-19 infection. Testing might be easier to access soon, provided you’re willing to drop some cash on an at-home test. LabCorp has announced its new “Pixel” test kit has received the first Emergency Use Authorization (EUA) from the FDA to test for COVID-19 at home.
Several biotech firms have announced plans to develop at-home testing kits for the novel coronavirus, but the FDA has expressly forbidden making these kits available until it can complete the necessary analysis. LabCorp is the first to get provisional approval, and that’s probably because it’s not a full testing kit in your home.
Like the company’s other Pixel-branded products, the COVID-19 test is actually an at-home sample collection kit. Users collect a sample via a nasal swab, seal it in a special container, and ship it with the included package to a LabCorp facility. The test conducted on the sample is the same one being done in labs around the world. It relies on RT-PCR (Reverse transcription-polymerase chain reaction) to turn RNA into DNA and search for sequences matching SARS-CoV-2, which is an RNA-based virus.
A positive result from this test indicates that the user has an active coronavirus infection. The FDA considers these results to be valid, but other at-home tests without an EUA are not. The agency is working with other companies on certification, some of which want to offer at-home serological testing. These blood tests look for antibodies in the blood that can indicate whether a person currently has or has previously had COVID-19.
LabCorp already offers at-home collection kits for various tests like cholesterol, diabetes, and colorectal cancer. The most expensive of them is $99, but the COVID-19 kit will cost $119. LabCorp currently has limited numbers of kits available, so it’s prioritizing healthcare workers and first-responders. You have to run through a quick survey on the company’s site before you can purchase the kit. LabCorp plans to make the kits available more widely soon.
With reliable testing, public health officials can use contact tracing to identify those most at risk of infection. At that point, we may be able to slowly return to some semblance of normality.