LabCorp‘s at home COVID-19 RT-PCR test becomes the first home testing kit for the disease to be approved by the FDA. This test kit provides a sample of collection materials that includes the nasal swab to the user, who later uses the included package to return the sample to the lab for testing.
FDA had not authorized any at-home testing or sample collection kits until now. It notes that testing kits by startup companies that were not authorized did not follow the guideline that they had laid out.
Some labs around the world have been providing at-home serology tests, but they are not viewed as tests that can confirm COVID-19 by the FDA. Opening up home testing even if it is just sample collection is a huge step of change in the way the FDA has been handling things.
The agency recently updated its guidelines and noted that it is working with at-home test providers to come up with the best way to make these kits available to the public as it “sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection.”
LabCorp is a medical diagnostics company based in the US that has experience of more than 40 years. It has provided at-home testing via its Pixel line for diabetes, cardiac lipid conditions, and cancer. From what it looks like, it seems like the FDA is favoring LabCorp's long-standing experience in terms of opening up for at-home collection for COVID-19 and ensuring that the tests are accurate.
Testing for COVID-19 currently relies on in-clinic, hospital, and drive-through sites testing. The tests have a high bar in terms of symptom presentation and risk profile, and this administration exposes healthcare workers to COVID-19, and they might as well get infected.
At-home testing could drastically increase overall testing in the country and decrease the risk for healthcare professionals in the process. It will also help paint a better picture of the true depth and extent of the COVID-19 pandemic.
