Abbott has received new COVID-19 diagnostic approvals in Europe for its rapid Panbio antigen test, clearing it for self-performed screening under supervision as well as widespread use by people who have not shown symptoms of the disease.
The Panbio lateral flow test, unavailable in the U.S., operates much like the company’s card-sized BinaxNOW antigen test, which the FDA has authorized for home use: A nasal swab is inserted into the small, portable device, and a visual result is provided within about 15 minutes, similar to a home pregnancy test.
Abbott has shipped 200 million Panbio antigen tests to 120 countries since last August, the company said, adding that the latest CE marks could help make the diagnostic a useful tool for frequently screening large numbers of people at workplaces, schools, recreational settings, airports and elsewhere.
"Rapid testing continues to be one of our most important tools for fighting this pandemic, and the ability to perform mass screening allows us to expand testing and reach more people in more places," President and CEO Robert Ford said in a statement.
While at least 1 in 3 cases of COVID-19 may be asymptomatic, research has shown they may be linked to more than half of all new infections—as people who are unaware they are carrying the virus may not isolate themselves or practice strict social distancing.
Abbott plans to pair its rapid tests with a smartphone app that will allow people to prove they’ve been cleared. The Navica app is designed for people entering a workplace or school or boarding airplanes and cruise ships.
In addition, the company is linking its tests to a web-based surveillance tool that gathers epidemiological data for healthcare professionals. The Sympheos platform can provide heat maps and testing trends while also tracking the prevalence of other diseases at risk for co-infection, such as malaria and HIV. In those efforts, Abbott has been working with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation to make its Panbio tests available to low- and middle-income countries.
Abbott has also been using its rapid antigen tests to help clear its own employees through a phased program across its global workforce that began last October.
"Our experience proves that testing helps our employees feel safer and more comfortable coming into the office during this time, so they can more effectively collaborate with each other and perform their duties," said Mary Moreland, Abbott’s executive vice president of human resources.
In Abbott’s clinical studies, the Panbio test has shown a false-negative rate of 6.2% and no false positives among people who have not shown any symptoms but are still carrying high levels of the coronavirus, making it more likely to spot people who could pass on the infection.
Among people with slightly lower viral loads, the false-negative rate rose to 20%, while the rate across all positive samples in the study came in at about 33%.
Antigen tests on the whole are not as accurate as molecular-based PCR tests, but that accuracy comes with trade-offs—such as the need for centralized laboratory equipment and potentially days to turn around a result—which may delay a person from safely isolating themselves or make it a poorer option for mass screening. In addition, negative antigen readings alone should not be used to completely rule out a COVID-19 infection.
Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) published findings evaluating the BinaxNOW test’s use in real-world testing, finding that it may miss about two-thirds of asymptomatic cases with a false-negative result.
However, the CDC study also found the antigen diagnostic was more accurate at finding COVID-19 cases among people who had reported symptoms of the disease in the previous seven days, with a test sensitivity of 71.1%—as well as in potentially infectious people with culturable virus but no symptoms, where it correctly identified 78.6%. Abbott said it is currently pursuing an FDA authorization for an asymptomatic indication for BinaxNOW.