NEW YORK – Diagnostics developer Quidel announced Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for a readerless rapid antigen test to detect SARS-CoV-2 infection.
The test, called the QuickVue SARS Antigen test, is authorized for point-of-care use directly from patient anterior nares swab samples within the first five days of symptom onset, the firm said in a statement.
Quidel said it expects to ramp its manufacturing up to 600 million QuickVue SARS Antigen tests per year by the end of 2021.
The firm also noted that the 10-minute, visually read test has a positive predictive value of 97 percent and a negative predictive value of 99 percent.
"We will scale immediately to supply the more than 30,000 QuickVue professional market customers we serve today and look forward to extending the benefits of this technology as broadly and rapidly as possible in the months and years ahead," Quidel President and CEO Doug Bryant said.
Quidel now has five EUAs for SARS-CoV-2 assays, including a standard Lyra PCR test, one that is extraction-free, and SARS-CoV-2 and combination COVID and flu rapid antigen tests on its Sofia instrument. It is also developing a combination SARS-CoV-2 and influenza Lyra test
Regarding Sofia, the firm said its current run rate is approximately two million tests per week, but that it is building additional production lines to more than double the current capacity and to reach a run-rate of over 240 million Sofia tests per year by the third quarter of 2021.
As a readerless antigen test, the QuickVue test may be most similar to the BinaxNow from Abbott Laboratories. To date, the federal government has supported the Abbott test with $760 million in funding and distributed 80 million tests.