The FDA has authorized the first test for COVID-19 that can be conducted partially at home. The "Pixel by LabCorp home collection kit" from LabCorp allows patients to collect their own mucus sample at home, then send it off to a lab for testing without breaking self-isolation. Hopefully, this process will allow more patients to get tested, and offer more accurate data on the state of the coronavirus pandemic in the U.S.
The U.S. is still behind on its COVID-19 testing capacity, but the new home testing kit approved by the Food and Drug Administration may help. On Tuesday, the FDA announced that it was re-issuing the emergency use authorization for LabCorp's COVID-19 RT-PCR Test. The administration's comissioner, Steven M. Hahn, said that this is the result of "around the clock work" to find "tests that include home sample collection." He said that LabCorp's kit has proven to be "as safe and accurate as sample collection at a doctor's office, hospital or other testing site."
Patients who use LabCorp's "Pixel" testing kit will mail their sample in an insulated container back to a LabCorp lab to find out whether they are positive for COVID-19 or not. The company hopes to make the product available in most states in the coming weeks. It will be available with a prescription from a doctor.
The test will involve putting a cotton swab deep into the patient's nasal passage to collect a sample, and it must be done with some concentration on sterility for the test to work. Patients will not be able to use their own cotton swabs for the test, due to concerns of cross-reactivity. The FDA also notes that the authorization for the Pixel does not extend to other at-home collection of patient samples, nor for tests conducted entirely at home.
Access to testing remains one of the biggest issues in the United States' coronavirus crisis. A report by Five Thirty-Eight this week noted that there are now 57 different kinds COVID-19 tests approved by the FDA, being conducted by disparate labs all over the country. However, the way that these tests that are being developed may not be optimal for the fast recovery of the nation, as they focus on "speed, rather than quality."
PCR tests like the LabCorp Pixel kit are "direct tests," which test for the presence of COVID-19 in the patient. Doctors are also relying on "indirect tests," which test for antibodies developed to combat the virus. Experts say both will be required to end social distancing, but so far laboratories are focused on using what they have rather than developing the means to do more. The University of Washington's Dr. Alex Greninger said that it would be preferable if there were just one testing platform that was standard for all medical facilities. For the latest on the coronavirus pandemic, visit the websites of the CDC and the World Health Organization.0comments