WASHINGTON – The Food and Drug Administration (FDA) approved this Tuesday a test that allows the diagnosis of COVID-19 through the study of samples obtained by patients themselves from home, They must then send them to a laboratory for analysis.
This was announced by this federal organization in a statement published on its website, in which it explains that this PCR test – that is, that looks for fragments of genetic material of the pathogen – developed by Laboratory Corporation of America (LabCorp) allows the study of samples Nasally collected by the patients themselves using a kit that has swabs and a saline solution.
Once patients collect the sample, they will have to send it in an isolated package to LabCorp, where it will be studied.
FDA Commissioner Stephen Hahn stressed the safety and effectiveness of the new test: “We work with LabCorp to ensure that the data obtained from the collection of samples from patients at home is as safe and accurate as the collection of samples in a doctor’s office, hospital, or other testing site. “
On its website, Pixel, a company owned by LabCorp, announces that the general consumer will be able to access this test in the coming weeks, although at the moment it will only be available to healthcare personnel, although its price is $ 119 for everyone.
In its statement, the FDA stresses that patients should only use the cotton swabs provided by LabCorp in the package that makes up the test, as there is concern about the possible cross contamination that could cause the use of cotton swabs other than those supplied .
Also, remember that this authorization does not mean that all the SARS-CoV-2 tests that can be performed at home have been authorized or will be.