The Food and Drug Administration (FDA) authorized the first diagnostic test with a home collection option for COVID-19, the agency said in a news release.
Specifically, the FDA reissued the emergency use authorization (EUA) for the Laboratory Corporation of America’s (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home.
“We worked with LabCorp to ensure the data demonstrated that at-home, patient-sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” said FDA Commissioner Stephen M. Hahn, MD.
Patients will collect samples at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
In a statement, LabCorp officials said they first will make the test kits available to first responders and healthcare workers who may have been exposed to COVID-19 or may be symptomatic. The company then plans to make the COVID-19 self-collection kits available to consumers, with a doctor’s order, in the coming weeks.
The FDA said 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 collect 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 for patients to use to collect their sample, FDA said.
“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 FDA continues to work with test developers to determine whether or not Q-tip-style cotton swab can be used safely and effectively with other tests,” the agency said in a statement.
“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,” the FDA said.
