The FTD (Food and Drug Administration) has just given emergency use authorization to a COVID-19 test called BinaxNOW that requires about 15 minutes and can be performed without laboratory equipment. It is going to cost $5 and runs on a simple card using the technology the same as a pregnancy test.
Abbott, a health care company, developed a COVID-19 testing card. The company is also introducing an app that synchronizes with the tests and offers a “digital health pass” to people who test negative for the virus, and they can view on their smartphone. In a comment, CEO Robert Ford said the combination of the app and the test provides a “comprehensive testing solution.”
In a press release, the company said it is preparing to produce about 50 million cards a month by October. “
Jeff Shuren, director of the FDA Center for Devices and Radiological Health, made a statement. He said the new antigen test is an important advancement. The test has a simpler design. The company expects to conduct a large number of tests in the coming months. This advancement plays a key role in the fight against the pandemic.
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According to the FDA release, the test is usable in doctors’ offices, emergency rooms, and classrooms. It uses a nasal swab. The patient’s nasal sample goes directly into the BinaxNOW strip. If the test is positive for COVID-19, a colored line appears.
BinaxNOW operates by identifying the small protein particles on the coronavirus surface, instead of the virus’s genetic sequences. Tests that look for proteins, called antigen tests, appear to be less accurate instead of the virus. But some researchers suggest that the best way to monitor the COVID-19 pandemic is by regular, cheap monitoring with a less reliable method.
Abbott claims the test correctly detects 97.1% of the time a coronavirus infection and correctly shows 98.5% negative result of the time.
Most of the COVID-19 samples have to be sent off to a laboratory for review. This summer, people around the US reported awaiting test results for up to a week. Joseph Petrosino, a professor of molecular virology and microbiology of the Baylor College of Medicine, told in a statement from Abbott: “With a quick antigen test, you can get a result very fast, getting infectious people off the streets and into quarantine, so they don’t spread the virus.”