FDA Approves First Test for Patient At-Home Sample Collection for COVID-19

The FDA has approved the first diagnostic test with a home collection option for the coronavirus disease 2019.

The FDA has approved the first diagnostic test with a home collection option for the coronavirus disease 2019 (COVID-19).

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 samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

The authorization only applies 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. The FDA notes 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 reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail it in an insulated package to LabCorp for testing.

LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a physician’s order, in the coming week, according to the FDA’s press release.

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, according to the press release. The FDA continues to work with test developers to determine whether or not Q-tip-style cotton swabs can be used safely and effectively with other tests.

Reference

  • FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection [press release]. FDA website. Published April 21, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection. Accessed April 21, 2020.