Quick Covid test earns approval

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A nasal swab test for COVID-19—clinically evaluated by the University of Rochester Medical Center—has been given the green light for use by health care providers. 

The size of a credit card, the Abbott BinaxNOW COVID-19 Ag Card Point of Care diagnostic test detects the presence of COVID-19 antigen. It also provides a free phone app for persons who receive a negative result, URMC officials say. 

Employers and schools will be able to view and verify the information on a mobile device (the app can display a temporary encrypted digital pass via a QR code). The $5 test has received emergency use authorization from the U.S. Food and Drug Administration.

“This really exciting,” says Kian Merchant-Borna, faculty in the Department of Emergency Medicine, who is the site principal investigator of the study and of the Emergency Medicine Industry Sponsored Research Program. “Eventually, anyone in their home will be able to use this, before you send your children off to school, or before you go to visit your grandparents. It’s the same technology as a urine pregnancy test, and just as easy to use.”

The medical center has enrolled more than 150 participants so far, the largest number across the 19 universities involved in testing the system. Subjects were chosen from adults at the Strong Memorial Hospital Emergency Department who either tested positive for COVID-19 or were suspected to be infected with coronavirus.

Results from the sites showed the test accurately diagnosed a coronavirus infection (sensitivity) 97.1 percent of the time and returned a negative result (specificity) 98.5 percent of the time. The antigen test detects pieces of viral proteins quickly without the need for trained technicians and advanced equipment. By contrast, the Reverse Transcription-Polymerase Chain Reaction method tests the viral nucleic acid and requires a PCR machine.

Health care workers can open a test card, lay it flat and add an extraction reagent to a nasal swab sample from a patient. Within five to 15 minutes, the absence or presence of blue colored lines provides an answer, much like a pregnancy test.

“With a rapid test like this, results are near immediate, getting infectious individuals isolated and preventing further spread of the virus” Merchant-Born says.

Abbott expects to ship out “tens of millions of tests” for COVID-19 this month, ramping up to 50 million tests a month at the beginning of October, the company says.

While noting the performance of antigen testing is not as sensitive or specific as RT-PCR, UR Medicine may evaluate how such testing could complement and enhance existing testing capacity for defined situations in the future, officials say. 

Smriti Jacob is Rochester Beacon managing editor. All coronavirus articles are collected here.

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