COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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In Bid to Increase Serial Testing Capabilities, FDA Significantly Expands Authorization for Over-the-Counter COVID-19 Tests

FDA maze of regulations

Three new authorizations granted by the FDA for over-the-counter and point-of-care COVID-19 tests used for serial testing

The US Food and Drug Administration (FDA) announced three new COVID-19 test authorizations to promote the availability of serial testing. All three tests had previous emergency use authorizations (EUAs), but these EUAs did not allow the flexibility to provide serial testing capabilities.

The new authorization for these tests expands their use to allow point-of-care testing or at-home, over-the-counter testing that was not previously permitted.

“Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response—many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19,” Jeffrey Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health, said in a recent statement.

“The FDA has taken many steps to support test development throughout the pandemic,” Shuren continued, “including authorizing tests quickly, offering many avenues for test developers to work with us to get their tests on the market, if shown to be accurate and reliable, and issuing enforcement policies for COVID-19 tests. As the pandemic has progressed, we have worked with test developers wishing to add screening claims.”

The test authorizations listed by the FDA’s recent announcement include:
1. Quidel QuickVue At-Home OTC COVID-19 test—authorized for OTC at-home serial screening
2. Abbott BinaxNOW (multiple configurations)
• Abbott BinaxNOW COVID-19 Antigen Self Test—authorized for OTC at-home serial screening
• Abbott BinaxNOW COVID-19 Ag Card 2 Home Test— authorized for OTC at-home serial screening with telehealth proctor
• Abbott BinaxNOW COVID-19 Ag 2 Card—authorized for POC serial screening without a prescription
3. BD Veritor System for Rapid Detection of SARS-CoV-2—authorized for POC serial screening with a prescription

Related Resource:

FDA: FDA Continues to Advance Over-the Counter and Other Screening Test Development