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FDA Authorizes First COVID-19 Test for At-home Sample Collection
The first diagnostic test with a home collection option for COVID-19 was recently authorized by the FDA.
The first diagnostic test with a home collection option for coronavirus disease 2019 (COVID-19) was recently authorized by the US Food and Drug Administration (FDA).
More specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of self-collected samples by patients at home using LabCorp’s Pixel by LabCorp™ COVID-19 test home collection kit.
“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Stephen M. Hahn, MD, in an FDA press release. “Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
The reissued EUA permits testing of a sample collected from a patient’s nose using the designated self-collection kit that comes with specific Q-tip-style nasal swabs and saline. Once patients self-swab, they mail their sample back to LabCorp in an insulated package for testing.
It is important to note that due to concerns with sterility and cross-reactivity due to inherent genetic material in cotton swabs, other generic cotton swabs should not be used with this test.
The FDA is continuing to work with test developers to determine if Q-tip-style cotton swabs can be used safely and effectively with other tests, said the agency in the press release.
The FDA also stressed that this EUA 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.
LabCorp intends to have the Pixel by LabCorp COVID-19 test home collection kit available to consumers in most states with a physician’s order in the coming weeks.
For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.
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