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The BinaxNOW COVID-19 Ag Card (Abbott) rapid antigen test for SARS-CoV-2 can now be used at home with a prescription, according to a new emergency use authorization (EUA) from the US Food and Drug Administration (FDA).
In August, the FDA authorized the BinaxNOW COVID-19 Ag Card as a point-of-care test in clinical settings, as reported by Medscape Medical News.
The new EUA for the BinaxNOW COVID-19 Ag Card Home Test clears the test for prescription use at home with self-collected nasal swab samples from individuals ages 15 or older who are suspected of having COVID-19 and who are within the first week of symptom onset.
It is also authorized for use with adult-collected nasal swab samples from individuals ages 4 or older who are suspected of having COVID-19 within 7 days.
Abbott has partnered with digital health provider eMed to allow the test to be completed at home, according to a company news release.
The user accesses the eMed service through Abbott's NAVICA app, which can be downloaded from the Apple and Android app stores. Once eligibility requirements are met, the test kit is shipped to the person's home or a pick-up location, allowing them to remain isolated until their status is known.
With the test kit in hand, the home user logs into the eMed portal for their guided testing session, with results available in 15 minutes, according to the company. An eMed certified guide is available to answer questions throughout the testing process.
The cost of the test and service is $25, and eMed reports all test results to relevant public health authorities in accordance with local, state, and federal requirements.
"FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options," FDA Commissioner Stephen M. Hahn, MD, said in a news release.
The BinaxNOW COVID-19 Ag Card Home Test has "the potential to support testing for millions of people," he added.
The FDA cautions that while antigen tests are specific for COVID-19, they aren't as sensitive as molecular PCR tests. "Positive results from antigen tests, while generally highly accurate, may be subject to false-positive results, especially in areas where there are fewer infections," the agency notes.
The FDA recommends that people with positive results self-isolate and seek additional care from their healthcare provider. Negative results, on the other hand, don't preclude an individual from being infected with SARS-CoV-2. People who test negative may need additional testing, particularly those who continue to have COVID-like symptoms.
"We will continue to work with test developers to support the availability of more innovative testing options," Jeff Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health, said in the release.
Earlier this week, as reported by Medscape Medical News, the FDA granted an EUA for the Ellume COVID-19 Home test, the first fully at-home test for SARS-CoV-2 available without a prescription.
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December 18, 2020 at 02:01AM
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FDA OKs Home Use of BinaxNOW 15-Minute COVID-19 Antigen Test - Medscape
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