FDA has granted EUA for LabCorp’s COVID-19 RT-PCR Test for at-home self-collected patient samples using its Pixel by LabCorp COVID-19 Test home collection kit
LabCorp secures FDA EUA for its COVID-19 RT-PCR test for at-home sample collection using its Pixel by LabCorp COVID-19 Test home collection kit. (Credit: PDPics from Pixabay.)
The US Food and Drug Administration (FDA) has authorised Laboratory Corporation of America (LabCorp)’s new COVID-19 diagnostic test with an at-home sample collection option.
The FDA has re-issued the emergency use authorisation (EUA) for the company’s COVID-19 RT-PCR Test, facilitating testing of at-home self-collected patient samples using its Pixel by LabCorp COVID-19 Test home collection kit.
FDA Commissioner Stephen Hahn said: “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.
“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.
LabCorp home self-collection kit contains a specific Q-tip-style cotton swab
The reissued EUA for LabCorp’s molecular test would facilitate testing of samples collected from the patient’s nose using a specific self-collection kit, which comprises nasal swabs and saline.
LabCorp said that the patients can self-swab to collect their nasal sample and mail their sample in an insulated package to its testing lab. The company is planning to commercialise its Pixel by LabCorp COVID-19 Test home collection kits in the coming weeks.
The LabCorp home self-collection kit contains a specific Q-tip-style cotton swab, intended for patients to collect their sample. Other cotton swabs are not allowed to be used with the test, due to sterility and cross-reactivity concerns due to inherent genetic material in cotton swabs.
The US regulatory agency is said to work with test developers to determine the safety and effectiveness of Q-tip-style cotton swabs, for use with other tests.
The FDA authorisation is applicable only for 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, but not for at-home collection of patient samples using other collection swabs, media, or tests.
Hahn 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.”