The U.S. Food and Drug Administration has just announced an emergency use authorization for the Quidel QuickVue At-Home COVID-19 Test. This is the second FDA approved home testing kit.
This new testing kit will be available by doctors prescription for everyone over the age of 14 and for children 8+ with family member assistance. The new at home testing kits, that have now been approved by the FDA, are available to all patients that see a doctor within the first 6 days of symptoms.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices & Radiological Health said, “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic. The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”
In addition to this new prescription home test, Quidel also was issued an EUA in December 2020 for their QuickVue SARS Antigen Test which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.
About the Food and Drug Administration
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.