BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run on BD’s highly portable Veritor instruments; the company already has about 25,000 Veritor instruments installed at healthcare providers and pharmacies across the U.S.
The assay can produce results in 15 minutes, with 84% sensitivity (ability to detect true positives) and 100% specificity (ability to exclude false negatives).
“This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors’ offices,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD.
“Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts,” Hickey said in a news release.
The news from BD comes nearly two months after FDA issued a first-of-its-kind emergency use authorization for Quidel‘s COVID-19 antigen test.
Antigen tests quickly detect fragments of proteins found on or within the virus. FDA has described positive results from antigen tests as highly accurate, but there’s a higher chance of false negatives than the slower polymerase chain reaction (PCR) tests that look for genetic material from the virus. FDA officials have described antigen tests as “important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests.”
A BD spokesman noted that because antigen test sensitivity is lower, FDA recommends confirmatory testing by molecular methods if needed for patient management — the same type of guidance that FDA has for similar types of immunoassay tests for other infectious diseases.