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Sources: FDA press release, AugThe Wall Street Journal, August 26, 2020. Rapid antigen tests are less sensitive than lab-based polymerase chain reaction tests, so negative results may need to be confirmed with a molecular test.Ībbott plans to make up to 50 million tests available per month in the U.S. QuickVue At-Home OTC COVID-19 Test, 1 Pack, 2 Tests Total, Self-Collected Nasal Swab Sample, 10 Minute Rapid Results. The Abbott test typically costs $5, while other authorized antigen tests cost between $15 and $50.Īccording to data from Abbott, the new antigen test is highly specific and accurately detects 97% of positive cases. BinaxNOW COVID-19 Antigen Self Test, 1 Pack, 2 Tests Total, COVID Test With 15-Minute Results Without Sending to a Lab, Easy to Use at Home. The test can be administered by a health-care provider at point-of-care settings, such as doctor's offices, schools, and emergency rooms, within 7 days of symptom onset. This text has received FDA Authorization for. The BinaxNOW test is a lateral flow immunoassay intended for the detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs. A simple solution for COVID-19 infection detection, with rapid results in the convenience of your home. The PCR tests identified an additional 14 students who were positive for COVID-19 they were moved to isolation. It has been authorized by the FDA under an emergency use authorization. Based on the BinaxNOW test, 18 students tested positive and were moved to isolation. It is the first antigen test that allows results to be read directly from the testing card itself, similar in design to a pregnancy test, and returns results in about 15 minutes. On a January conference call, investors learned the hard work was paying off: Abbott had sold 2.4 billion in coronavirus tests, mostly rapid ones, in the final quarter of 2020. The BinaxNOW COVID-19 Ag Card Home Test has not been FDA cleared or approved. The FDA has issued an Emergency Use Authorization (EUA) to Abbott Diagnostics for its BinaxNOW COVID-19 Ag Card, a rapid-response antigen test for SARS-CoV-2. NCDHHS is partnering with community organizations, called Community Access Points, for test distribution.