APhA coronavirus watch: FDA authorizes first at-home sample collection test for COVID-19
FDA has authorized the first diagnostic test with a home collection option for COVID-19, according to an April 21 agency news release. Specifically, FDA reissued the emergency use authorization (EUA) to permit testing of samples self-collected by patients at home using the Laboratory Corporation of America's (LabCorp) Pixel by LabCorp COVID-19 RT-PCR Test home collection kit.
LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks, said FDA.
The self-collection kit contains a specific Q-tip-style cotton nasal swab and saline. Once patients self-swab to collect their nasal sample, they mail their sample in an insulated package to a LabCorp lab for testing.
FDA cautioned that because of concerns about sterility and cross-reactivity due to inherent genetic material in cotton swabs, other cotton swabs should not be used with this test at this time.
The agency said it is working with test developers to determine whether Q-tip-style cotton swab can be used safely and effectively with other tests.
This authorization applies only to the LabCorp COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit. It 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, said FDA.