Franklin Lakes-based BD has begun selling the first over-the-counter COVID-19 rapid antigen test that uses computer vision technology in a smartphone to interpret testing results.
The company said the BD Veritor At-Home COVID-19 Test, which was given emergency use authorization by the FDA at the end of August, is now available for purchase by consumers online at Amazon.
BD officials said the test also is available for businesses, governments and schools through traditional BD sales channels. Company officials feel the test is an option for businesses, enterprises and schools looking to provide a self-testing method for employees or students.
BD officials said the test uses the Scanwell Health mobile app to interpret and provide a digital display of testing results in 15 minutes. They also said the test is one of the only at-home tests to fully automate reporting of results to federal and state public health agencies and provides a streamlined experience for optional reporting to businesses and schools.
Dave Hickey, president of life sciences for BD, said the impact of the test will increase during flu season, as flu symptoms can mirror COVID-19 symptoms. The product, however, only has been authorized for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
Hickey said the product’s indicator will bring peace of mind.
“There is no guessing game about one line or two, as is sometimes the case with visually read tests,” he said. “You get a definitive ‘positive’ or ‘negative’ digital display of the result.”
Hickey said the BD Veritor test has been designed to overcome other issues, including:
- Ease of use: The mobile app from Scanwell yields reliable test results in 15 minutes. The app is available on iOS and Android and provides step-by-step video instructions on how to collect and transfer the nasal swab sample to the test stick. The app also has built-in timers and alerts to ensure users are waiting the required time periods before proceeding to the next step of testing. The guided app allows users to self-test with confidence, without having to connect live with a proctor.
- Pain-free: BD officials say a simple nasal swab provides a pain-free experience. The test stick has a built-in quality check that confirms the application of a human sample. This sample adequacy control will yield an invalid result if no human sample is detected. Internal reagent controls also act to confirm that the sample was appropriately applied to the test stick.
- Automated reporting: The app also automates secure, timely reporting to state and federal public health officials. Because results are stored securely, reporting can be configured to automate reporting to businesses or schools as well.
BD officials said the test can be used on children as young as 2. It is designed to be easily performed at home by people 14 years of age or older.
The product comes with two single-use tests in each box. It has a suggested retail price of $39.99, but it is available on Amazon.com for $26.50 through December to U.S. customers, as part of BD’s partnership with the U.S. government.