COVID-19 Resource Center

COVID-19 Resource Center

Issue: January 2021
Source: Press releases
Disclosures: Hahn and Shuren report no relevant financial disclosures. Ford is an employee of Abbott.
January 21, 2021
3 min read
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FDA authorizes at-home tests for COVID-19, flu

Issue: January 2021
Source: Press releases
Disclosures: Hahn and Shuren report no relevant financial disclosures. Ford is an employee of Abbott.
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The FDA recently authorized several methods for at-home testing and sample collection for COVID-19 and influenza.

The agency issued an emergency use authorization (EUA) for an over-the-counter home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is approved for use in persons aged 2 years or older, whether or not they show any COVID-19 symptoms.

In an analysis, the test correctly identified 96% of positive samples and 100% of negative samples in patients with COVID-19 symptoms, the FDA said.

The authorization “is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” FDA Commissioner Stephen M. Hahn, MD, said in a press release.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies and giving Americans more testing options from the comfort and safety of their own homes,” Hahn said.

Stephen M. Hahn, MD
Stephen M. Hahn

The FDA first issued an EUA for an at-home COVID-19 test in November, but it required a prescription.

$25 test

Since the beginning of the pandemic, more than 225 COVID-19 diagnostic tests have been authorized, including more than two dozen that offer collection of samples at home, according to the FDA.

The FDA also issued an EUA for Abbott’s BinaxNOW COVID-19 Ag Card rapid at-home antigen test, the company announced. The test will cost $25 and will produce results in 15 minutes, according to Abbott, which said it is the most affordable at-home COVID-19 test currently available.The test is available with a prescription for patients who are suspected by their health care provider of having COVID-19 within the first 7 days of symptom onset and must be used under the supervision of a telehealth proctor. It is authorized for home use via self-collection for patients aged 15 years or older, or via adult-collected nasal swab samples from individuals aged 4 years or older.

“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 B. Ford, said in a press release.

Test results are accessed via Abbott’s NAVICA app. According to the release, Abbott expects to administer approximately 30 million and 90 million BinaxNOW tests throughout the first and second quarters of 2021, respectively.

The FDA also authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit — the first direct-to-consumer COVID-19 test kit — for use by anyone aged 18 years and older.

The test kit allows an individual to self-collect a nasal swab sample at home and then send it for testing to LabCorp, according to the FDA. Positive or invalid test results are then delivered to the user by phone call from a health care provider, whereas negative test results are delivered via email or an online portal.

According to the FDA, the kit can be purchased online or in a store without a prescription. It will also allow users to access information about their COVID-19 infection status that could help them determine whether they need to self-isolate and to assist with health care decisions after discussion with a health care professional.

“While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a press release.

Home collection for COVID-19, flu

Additionally, the FDA authorized the first combination test that allows patients to collect saliva samples at home and have them analyzed at a laboratory for the presence of COVID-19, influenza A and influenza B.

The use of RC COVID-19 +Flu RT-PCR Test (Quest Diagnostics) in tandem with Self-Collection Kit for COVID-19 +Flu (Quest Diagnostics) is intended for those with a respiratory viral infection “consistent with COVID-19” and for whom home collection is “determined to be appropriate” by a health care provider, the agency said.

The combination tests “can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results,” Hahn said in a press release. “This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

On its website, Quest Diagnostics indicated that it takes approximately 2 to 3 days for all patients and 2 days for “priority patients” (eg, hospitalized patients) to receive antibody and molecular diagnostic test results.