- The US Food and Drug Administration (FDA) authorizes the first diagnostic test with a home-collection option for COVID-19.
- FDA reissued 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.
- Patients can collect sample from their nose by using a designated self-collection kit that contain nasal swabs and saline. After collecting their nasal sample, they mail their sample in an insulated package, to a LabCorp lab for testing.
- The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab which can be used by patients 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.
- LabCorp intends to make home collection kits available to most of costumers in coming weeks.
- This 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. 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.
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