FDA gives its first emergency approval to a do-it-yourself home coronavirus test
People who want to test themselves at home for the novel coronavirus infection have a way to do so after the FDA gave emergency approval of LabCorp’s COVID-19 RT-PCR Test.
The emergency use authorization (EUA) allows the test only for nasal swab collected by the Pixel by LabCorp COVID-19 home collection kit.
“It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home,” the FDA said.
“The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample,” the agency said. “Due to concerns with sterility and cross-reactivity due to inherent genetic material in cotton swabs, other cotton swabs should not be used with this test at the present time.”
The FDA says the Pixel by LabCorp COVID-19 Test home collection kit should be “available to consumers in most states, with a doctor’s order, in the coming weeks.”
This story was originally published April 21, 2020 at 9:28 AM with the headline "FDA gives its first emergency approval to a do-it-yourself home coronavirus test."
