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Abbott SARS-CoV-2 Rapid Antigen Test Receives FDA EUA for At-Home Use

NEW YORK – Abbott announced Wednesday its BinaxNow COVID-19 Ag Card rapid test received Emergency Use Authorization from the US Food and Drug Administration for virtually guided at-home use.

The antigen test, which uses a lateral flow immunoassay format, qualitatively detects the nucleocapsid protein, and is authorized for prescription use with self-collected nasal swab samples at home in people 15 and older within the first seven days of symptom onset if a healthcare provider suspects they have COVID-19. Children between 4 and 14 years old may also use the test but must have an adult collect the sample, the FDA said in its statement.  

Abbott will use telehealth company eMed's digital health platform to facilitate the delivery of the test to homes and guide the collection and testing process. Abbott said in a statement it expects to deliver and administer 30 million tests in the first quarter of 2021, ramping up to 90 million in Q2. Currently, Abbott has the capacity to deliver 50 million BinaxNow tests per month and is expanding further. 

The test and service will cost $25 and can deliver results in 15 minutes without an instrument. The service will also use Abbott's Navica app to display the test results, the company said. EMed will determine eligibility, guide the self-collection process, and provide results through the Navica app. It will also fulfill the public health reporting requirements, Abbott said.

According to Abbott's data from 52 people, the sensitivity of the test was 91.7 percent and specificity was 100 percent, compared to PCR, in people a week or less after symptom onset at all cycle threshold, or Ct, counts. Sensitivity was 100 percent in people with Ct counts of 33 or below, which Abbott said are those who are most likely to be infectious. The Ct count is the number of times a PCR instrument needs to cycle through to amplify enough genetic material for it to be detectable, Abbott added.

"As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we're still hearing that many people can't access testing as quickly as they need it," Abbott President and CEO Robert Ford said in a statement. "That's why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes through this partnership with eMed, which allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy." 

Abbott's BinaxNow COVID-19 Ag Card, which FDA said in its statement is a different product than the home use test, received EUA for use at the point of care in August. Abbott on Wednesday also updated the clinical data for its BinaxNow COVID-19 Ag Card for professional use. In data from 10 clinical sites of 460 people, ages 6 to more than 60, the test demonstrated 84.6 percent sensitivity and 98.5 percent specificity, compared with PCR, in people at seven days or less after the onset of symptoms at all Ct counts. 

It demonstrated 95.6 percent sensitivity in people seven days or more after the onset of symptoms at Ct counts of 33 or less. Such patients are most likely to be infected and to spread COVID-19, Abbott said.

The data is exclusive of the at-home data for the BinaxNow COVID-19 Ag Card, Abbott noted.

The FDA has prioritized home-based tests for COVID-19 as the pandemic rages and the number of cases in the US continues to grow. Home-based testing, and especially home-based, antigen tests are viewed by many as a way to increase the number of individuals who get tested for the coronavirus. Earlier this week, Ellume received EUA for its over-the- counter, at-home rapid antigen test for SARS-CoV-2. Last month, Lucira Health received the first EUA for an end-to-end, home-based test for the detection of SARS-CoV-2.