U.S. Food and Drug Administration12.17.20
The U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.
The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
The test will be offered in partnership with a telehealth service that will take users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telehealth provider will also report all test results to the 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,” said FDA Commissioner Stephen M. Hahn, M.D. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”
In general, antigen tests are very specific for COVID-19, but are not as sensitive as molecular PCR tests. This means that there is a higher chance of false negatives than with many molecular 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.
Individuals with positive results should self-isolate and seek additional care from their health care provider. Negative results do not preclude an individual from SARS-CoV-2 infection. Individuals who test negative may need additional testing, particularly those who continue to experience COVID-like symptoms.
“With today’s authorization of the BinaxNOW COVID-19 Ag Card Home Test, there are now three tests that can be used completely at home,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We will continue to work with test developers to support the availability of more innovative testing options.”
Abbott Diagnostics Scarborough Inc’s BinaxNOW COVID-19 Ag Card, which is a different product than this home use test, is authorized for use at the point-of-care under an EUA that was issued in August 2020.
The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
The test will be offered in partnership with a telehealth service that will take users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telehealth provider will also report all test results to the 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,” said FDA Commissioner Stephen M. Hahn, M.D. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”
In general, antigen tests are very specific for COVID-19, but are not as sensitive as molecular PCR tests. This means that there is a higher chance of false negatives than with many molecular 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.
Individuals with positive results should self-isolate and seek additional care from their health care provider. Negative results do not preclude an individual from SARS-CoV-2 infection. Individuals who test negative may need additional testing, particularly those who continue to experience COVID-like symptoms.
“With today’s authorization of the BinaxNOW COVID-19 Ag Card Home Test, there are now three tests that can be used completely at home,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We will continue to work with test developers to support the availability of more innovative testing options.”
Abbott Diagnostics Scarborough Inc’s BinaxNOW COVID-19 Ag Card, which is a different product than this home use test, is authorized for use at the point-of-care under an EUA that was issued in August 2020.
