Resource: FDA Authorizes First Direct-to-Consumer COVID-19 Test System
Source: U.S. Food and Drug Administration
Synopsis: FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.
Comment: This kit can be purchased online or in local drug stores without a prescription. This is the first kit available for consumers to self-collect COVID-19 samples in their own home. This will help consumers decide the appropriateness of self-isolation or quarantine. They can communicate with their healthcare provider with more definitive evidence to aid in healthcare decisions.
