FDA Clears Way for Marketing First OTC COVID-19 Antigen Test

One area within COVID-19 care is the ability simplify testing to get more people to know if they in fact have the virus and get the proper treatment they need. Yesterday, the FDA announced it cleared the way for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18. That FDA announcement followed the clearance of a molecular home test earlier this year.¹

The Flowflex COVID-19 Antigen Home Test is a visually-read test cleared for OTC home use by symptomatic individuals within six days of symptom onset. It is cleared for individuals aged 14 years or older testing themselves, or adults testing individuals aged two years or older. In a study reviewed by the FDA, this test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.¹

“This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said in a statement . “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”¹

What You Should Know

The FDA's clearance of the Flowflex COVID-19 Antigen Home Test marks a significant step in advancing accessible COVID-19 testing.

The rise of at-home COVID-19 testing raises concerns about accurately capturing the true incidence rates of the virus.

The use of the 510(k) premarket review pathway for the ACON Flowflex COVID-19 Antigen Home Test underscores the importance of regulatory processes in ensuring the safety and effectiveness of these at-home testing options.

As with antigen tests authorized for emergency use, this test is intended to be used at least twice over three days with at least 48 hours between tests. This means that a symptomatic individual with an initial negative test result should be re-tested once between 48 and 72 hours after the first test using an antigen test for COVID-19 or followed up with a molecular COVID-19 test.¹

The FDA reviewed the ACON Flowflex COVID-19 Antigen Home Test through the 510(k) premarket review pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.¹

In earlier reporting by Contagion, there are concerns of true incidence rates of COVID-19 so aspects needed for public health reporting including appropriations of needed COVID-19 treatment resources can be achieved. A JAMA study sought to collect data on the frequency and results of at-home COVID-19 testing.

Investigators utilized the COVID-19 Citizen Science Study for their research. Launched in March 2020, the cohort study invited participants by word of mouth, social media, email, telephone, or patient portal. The study participants provided informed consent and baseline information, self-reporting race and ethnicity to help the investigators analyze demographic differences in unreported rest frequency and test positivity.

Each week, participants reported their recent COVID-19 testing and test results. In March 2022, the investigators asked participants to distinguish whether they tested with a “Fully at-home test kit, with my own sample collection and reading of my own results” or whether “a health care provider collected my sample” and sent it to a clinical laboratory.

To compare the self-testing with nationally reported COVID-19 testing, the investigators downloaded data from the Johns Hopkins Coronavirus Resource Center on August 15, 2022. They plotted averages of total daily tests and test positivity, fitting mixed logistic models with a random intercept for each participant. The participants’ testing data were controlled for time of test and demographic characteristics.

A total of 102,591 US participants enrolled in the study, 18% (n = 18642) of whom reported completing at least 1 COVID-19 diagnostic test from March 16-August 15, 2022. Of the 18,546 participants who submitted demographic information, the majority were female (67.8%; n = 12568) and non-Hispanic White (82.1%; n = 15231). The average age was 55 years.

During this study period, the proportion of COVID-19 tests conducted at home increased from 60% to more than 80%. From March until June 2022, the percentage of positive at-home tests was similar to that of officially reported tests. After June, at-home tests began to yield lower positivity rates than official tests.

According to the investigators, younger, female, non-Hispanic White individuals with higher social status were more likely than other participants to test for COVID-19 at home. However, positive at-home test results were most frequent among men and young adults.