Aug. 27, 2020—The FDA has issued emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card rapid test for the detection of COVID-19 infection.
The test is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals suspected of COVID-19 by a health care provider within the first seven days of symptom onset. A health care provider collects a patient’s sample using a nasal swab and then twirls the sample on a test card, about the size of a credit card, with a testing reagent added. Results are read directly from the testing card after 15 minutes, and no instrumentation is needed. The test has demonstrated a sensitivity of 97.1 percent and a specificity of 98.5 percent.
Abbott will sell the BinaxNow test for $5 and plans to make up to 50 million tests available each month in the United States at the beginning of October. The company is also offering a free mobile app, Navica, that will allow people to display their results when entering a facility that requires proof of testing.