LabCorp said on Wednesday that it has received Emergency Use Authorization for an over-the-counter version of its COVID-19 home test.
With the EUA, LabCorp is able to sell the test kit directly to consumers without requiring a prescription. The kit is the first over-the-counter at-home collection kit for SARS-CoV-2 to receive EUA.
Users can self-collect nasal swab samples and send them in for processing at LabCorp, which will run the samples on its COVID-19 PCR test. Healthcare providers will deliver positive or invalid results to patients, while negative results will be delivered by email or online portal.
“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. “While many home collection kits can be prescribed with a simple online questionnaire, this newly