Prescription And Non-Prescription At-Home COVID-19 Tests Granted EUA By FDA

The FDA is working to limit public exposure to COVID-19 by issuing emergency use authorization (EUA) for both prescription and non-prescription home-based testing. The Lucira COVID-19 All-In-One Test Kit can now be prescribed by healthcare providers allowing for quick at-home results. The LabCorp Pixel COVID-19 Test Home Collection Kit can be used and sent in for lab testing.

The Lucira COVID-19 All-In-One Test Kit is a onetime use kit that must be prescribed by a healthcare provider. The kit utilizes a self-administered nasal swab sample for those 14 years old and up and can provide results in 30 minutes. The sample is placed in a vial in the test unit and searched for SARS-CoV-2, the genetic material of the virus. This test is molecular as opposed to the antigen testing options that search for proteins in the virus. Results will appear on the kit’s light up display.

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This kit has also been approved for point of care (POC) settings such as doctors’ offices and hospitals. In these circumstances, the healthcare provider must administer the test for those under the age of 14.  Despite being utilized at home or in POC settings, healthcare providers are required to report results to their public health authorities. Many healthcare providers approve of this kit as it lessens the public transmission of the virus, however some are skeptical as the data is relatively new.

Another option for at home testing is the LabCorp Pixel COVID-19 Test Home Collection Kit, which does not require a prescription. This kit can be purchased online by those 18 and older through the Pixel by LabCorp website. LabCorp is also working for the kit to be available in stores. This is the first non-prescription based COVID-19 testing kit to be granted EUA by the FDA.

This kit requires an at home nasal swab to be sent to a LabCorp facility for testing. The kit is to be registered online where instructions will be provided. Positive or invalid results will reach the consumer through a phone call or by a health care provider. Negative results will reach the patient through an email or online portal. Those who utilize the online portal and have positive results can be guided by healthcare providers on treatment and actions.

These kits are not a substitute for a doctor visit but can help patients make decisions about handling COVID-19. These kits will provide quick results and ultimately help decrease the spread of COVID-19.