First at-home COVID-19 test approved
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for the first novel coronavirus (COVID-19) diagnostic test with an at-home specimen collection component, according to an announcement made yesterday by the agency.
In the statement, the FDA said it is amending an earlier emergency authorization granted last month to Laboratory Corporation of America for its COVID-19 RT-PCR Test. The agency will permit testing of samples self-collected by patients at home using the company’s Pixel by LabCorp COVID-19 Test home collection kit.
According to the statement, the reissued authorization permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once a patient self-swabs to collect their nasal sample, they mail their sample in an insulated package to a LabCorp lab for testing. 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.
The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample. 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 agency said.
The FDA said it continues to work with test developers to determine whether Q-tip-style cotton swab can be used safely and effectively with other tests.