The Food and Drug Administration on Tuesday announced that it authorized the first at-home collection kit for the coronavirus testing.
What are the details?
In a statement, the FDA said it reissued an “Emergency Use Authorization for LabCorp to COVID-19 RT-PCR Test” for patients to self-collect in the privacy of their own homes.
“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,” FDA Commissioner Dr. Stephen Hahn said.
“The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers,” he added. “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 statement added, “This 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 in their sample, in an insulated package, to a LabCorp lab for testing.”
The FDA did not note any turnaround time for patients to receive a result on their at-home test.
The kit comes with its own Q-tip-style swab, and the FDA cautions users to use only the provided swab for testing.
“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 statement added. “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.”
At the time of this writing, researchers at Johns Hopkins University estimate that at least 810,561 cases of COVID-19 have been confirmed in the United States, with at least 43,630 deaths because of the virus.