TEMECULA, CA — The U.S. Food and Drug Administration has issued Emergency Use Authorization for another COVID-19 test from Abbott, this one promising results in 15 minutes.
Illinois-based Abbott, which has a facility in Temecula, made the announcement Wednesday that its BinaxNOW COVID-19 Ag Card used for detection of active COVID-19 infection received the authorization. The portable, $5 test that's about the size of a credit card requires no equipment for processing, and is ideal for health-care providers doing frequent mass testing, according to the company.
The test is conducted using nasal swabs and is similar to a pregnancy test — an additional line appears on the card when a sample tests positive for the COVID-19 virus.
"The device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others," the company said in a released statement.
The test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription, according to Abbott.
"Our nation's frontline health-care workers and clinical laboratory personnel have been under siege since the onset of this pandemic," said Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco. "The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it."
The test is designed to be used on people suspected of COVID-19 within the first seven days of their symptom onset. It's being launched with NAVICA, a complementary no-charge mobile app for iPhone and Android devices, which allows people who test negative to display "a temporary digital health pass" that is renewed each time a person is tested through a health-care provider.
The data could be used to show proof of testing to organizations that require it.
"If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass," the company stated. "If test results are positive, people receive a message to quarantine and talk to their doctor. As they're required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app."
The app is not for contact tracing and only collects a person's first and last name, email address, phone number, zip code, date of birth and test results, according to the company.
In data submitted to the FDA from a clinical study conducted by Abbott and several U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1 percent positive agreement and 98.5 percent negative agreement in patients suspected of COVID-19 by their health-care provider within the first seven days of symptom onset, according to the company.
Lab-based tests may be more accurate, but the turnaround time can be problematic.
"With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results, according to Joseph Petrosino, Ph.D., professor at Baylor College of Medicine. "With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."
Abbott reported it will ship "tens of millions" of tests in September, ramping to 50 million tests a month at the beginning of October. "Hundreds of millions of dollars" have been invested by Abbott since April in two new U.S. facilities to manufacture BinaxNOW at massive scale, the company said. It's unclear if all the tests will be distributed in the U.S.
The BinaxNOW COVID-19 Ag Card is the sixth COVID-19 test that Abbott has launched in the U.S.
On Wednesday, Gov. Gavin Newsom announced the state had reached an agreement with Massachusetts-based PerkinElmer, whereby the company will build out a new California-based laboratory with a full supply chain to allow for greater testing at a decreased cost and with a much faster turnaround. The agreement has provisions that allow the state to back out if newer, better technologies become available, the governor said. Read more here.