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FDA Authorizes Quidel, Abbott, BD Coronavirus Antigen Tests for Serial Testing

NEW YORK — The US Food and Drug Administration has separately authorized three SARS-CoV-2 antigen tests — from Quidel, Abbott, and Becton Dickinson — for use in serial testing of asymptomatic individuals, the companies announced this week.

Quidel said that its QuickVue At-Home OTC COVID-19 Test has received FDA Emergency Use Authorization for use at-home by individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days, with at least 24 hours and no more than 36 hours between tests.

The non-prescription test is designed to detect SARS-CoV-2 nucleocapsid protein antigen in self-collected direct anterior nasal specimens from individuals aged 14 years and older or with adult-collected anterior nasal samples from individuals aged 2 years or older, Quidel said. It provides results within 10 minutes.

Last month, San Diego-based Quidel received FDA EUA for the prescription-only QuickVue At-Home COVID-19 test.

Abbott's BinaxNOW COVID-19 Ag Self Test received FDA EUA for over-the-counter use by children as young as 2 years old with adult-collected samples and for all people aged 15 years or older with self-collected samples when tested twice over three days with at least 36 hours between tests. It uses the BinaxNow COVID-19 Ag Card, which detects the SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swabs samples and provides results within 15 minutes, the company said.

With the EUA, Abbott Park, Illinois-based Abbott said that the BinaxNow COVID-19 Ag Card, which received FDA authorization in December for at-home use with a prescription, is also now available without a prescription.

Becton Dickinson said that its BD Veritor Plus System for Rapid Detection of SARS-CoV-2 received FDA EUA for the detection of nucleocapsid antigens in direct anterior nasal swabs in individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over no more than three days with at least 24 hours and no more than 48 hours between tests.

The test, which provides results in 15 minutes and requires a prescription, can be used in any setting with a CLIA certificate of waiver, the Franklin Lakes, New Jersey-based company said. Becton Dickinson received FDA EUA for the test's use in individuals suspected of SARS-CoV-2 infection last summer. 

"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. With the FDA's authorization of multiple tests, the public can be assured these tests have met our scientific standards for Emergency Use Authorization," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. 

In a note to investors, William Blair analyst Brian Weinstein said the three EUAs represent the "beginning of the next chapter in the COVID-19 testing evolution that started roughly a year ago," and noted that the requirement that these antigen tests be performed frequently due to their lower sensitivity versus molecular tests "actually can serve as a benefit to these companies in terms of the number of tests sold in these newly approved settings."