Resource: BinaxNOW COVID-19 Ag Card Home Test
Source: U.S. Food and Drug Administration
Synopsis: FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset, when an adult collects the sample. The BinaxNOW COVID-19 Ag Card Home Test is being offered in partnership with eMed Labs, LLC., a telehealth service that will take users step-by-step through the sample collection process, explain how to perform the test, and provide assistance in reading and understanding the results.
Comment: The FDA authorized Abbott Labs’ rapid COVID-19 test for at home use, although the doctors must prescribe the test for patients. This is the third at home test for COVID-19 which has been authorized by the FDA. Patients can buy the test for $25 in a drugstore and collect a sample with a nasal swab themselves and an app helps guide the testing process and provide results in about 15 minutes. Everyone 15 years or older or suspected of having COVID-19 by their healthcare provider and is within the first seven days of symptom onset are eligible for the test. It can also be used for children four years of age or older, though an adult needs to collect the sample. Abbot expects to deliver 3 million at home tests in the first quarter of 2021, with another 90 million in the second quarter. Again, this is not as accurate as a molecular PCR test. The authorization comes after the FDA cleared Ellume’s at home COVID-19. Ellume was authorized for use in anyone two years or older, either asymptomatic or symptomatic, and does not require a prescription.
