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COVID-19 Update: FDA Allows First Diagnostic Test Where Results Can Be Read Directly From Test Card

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For immediate release:

Silver Spring, MD – Today the United States Food and Drug Administration issued emergency use authorization for the first antigen test where results can be read directly from the test card, a design similar to some pregnancy tests. This simple design is fast and efficient for healthcare 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 available because the results can be read in a matter of minutes, directly on the test card. This means people will know if they have the virus almost in real time. Due to its simpler design and the large number of tests the company plans to do 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 Center for Radiologic Devices and Health.

HOW IT WORKS:

A healthcare professional rubs the patient’s nose and swirls the sample on a test card with test reagent added. After waiting 15 minutes, the healthcare professional reads the results directly from the test card. One line indicates a negative result; two lines indicate a positive result.

WHERE IT CAN BE USED:

This test could be used in healthcare settings, such as a doctor’s office, emergency room, or some schools. This test has been cleared for use in patients with suspected COVID-19 by their healthcare provider within seven days of symptom onset. Given the simple nature of this test, it is likely that these tests could be widely distributed. According to test maker Abbott, it plans to make up to 50 million tests available each month in the United States by early October 2020.

TEST DETAILS:

In general, antigenic tests are very specific, but are not as sensitive as molecular tests. Due to the potential for decreased sensitivity compared to molecular analyzes, negative results from an antigen test may need to be confirmed by molecular testing before making treatment decisions. Negative results of an antigen test should be considered in the context of clinical findings, patient history, and epidemiological information.

Emergency Use Authorization has been issued to Abbott Diagnostics Scarborough, Inc for its BinaxNOW COVID-19 Ag card.

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines and other biologicals for human use and medical devices for human use and veterinary. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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