RE: Abbott test FDA approved27 Aug 2020 06:53
The Food and Drug Administration has granted emergency authorization to Abbott for a cheap, portable coronavirus test that gives results in 15 minutes, the company said on Wednesday.
The device is about the size of a credit card, and opens like a book to reveal a small well. A health practitioner takes a swab from the patient’s nostrils, adds a few drops of chemicals into the hole, inserts the swab directly into the card and rotates it.
The device, called the BinaxNOW Covid-19 Ag Card, works by rapidly detecting fragments of virus in a sample, a method known as an antigen test. But while such tests are faster than those that rely on a technology called polymerase chain reaction, or P.C.R., they tend to miss more infections.
BinaxNOW is the fourth coronavirus antigen test to win an emergency authorization from the F.D.A. Earlier this month, the agency cleared one made by LumiraDx, a British firm.
Abbott said its new test detected virus in 97.1 percent of people who have it, and accurately reported no virus in 98.5 percent of people who don’t.
In March, the F.D.A. approved another rapid test developed by Abbott that was later found to miss a significant number of infections.
The BinaxNOW test will come with a mobile app for iPhone and Android devices that updates each time a person retakes it.
In a statement, the company said it would begin shipping millions of tests in September, ramping up to 50 million a month beginning in early October.
The test will cost $5.