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COVID-19 Update: FDA authorizes first diagnostic test where results can be read directly from the test card

November 6, 2020

SOURCE U.S. Food and Drug Administration SILVER SPRING, Maryland/PRNewswire-HISPANIC PR WIRE/ — The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first antigen test (Ag) donating the results canbe read directly from the test card s, a design similar to that of some pregnancy tests.…

SOURCE U.S. Food and Drug Administration

SILVER SPRING, Maryland/PRNewswire-HISPANIC PR WIRE/ — The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first antigen test (Ag) donating the results canbe read directly from the test card s, a design similar to that of some pregnancy tests. This simple design is fast and effective for health care providers and patients, and does not require the use of an analyzer.

“This new COVID-19 antigen test is an important addition to the tests already available because the results can be read in minutes, directly from the test card. This means that people will know if they have the virus in near real time. Due to its simpler design and the sheer amount of testing the company anticipates in the coming months, this new antigen test is an important step forward in our fight against the pandemic,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

HOW IT WORKS:

A health care provider takes a sample of the patient’s nose with a swab and places the sample on a test card with an added test reagent. After waiting 15 minutes, the health care provider reads the results directly from the test card. A line indicates a negative result; two lines indicate a positive result.

WHERE IT CAN BE USED:

This test could be used in places of care, such as a doctor’s office, emergency room, or some schools operating under a Clinical Laboratory Improvement Amendment Waiver Certificate (CLIA). This test has been authorized for use in patients with suspected COVID-19 by their health care provider within seven days of the onset of symptoms. Given the simple nature of this test, it is likely that these tests may be widely available. According to the test manufacturer, Abbott plans to make up to 50 million tests available monthly in the U.S. in early October 2020.

TEST DETAILS:

In general, antigen tests are very specific, but not as sensitive as molecular testing. Due to the possibility of decreased sensitivity compared to molecular assays, negative results of an antigen test may need to be confirmed with a molecular test before making treatment decisions. Negative results of an antigen test should be considered in the context of clinical observations, patient history and epidemiological information.

Emergency use authorization was issued to Abbott Diagnostics Scarborough, Inc for your BinaxNOW COVID-19 Ag card.

Visit this link for more information on Coronavirus Disease (COVID-19)

The FDA, an agency that is part of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and protection of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety of the supply of food, cosmetics, food supplements, and products that emit electronic radiation, and for regulating tobacco products in our nation. Consumer Information: 888-INFO-FDA, www.FDA.gov/Espanol

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