FDA Authorizes CLINITEST Rapid COVID-19 Antigen Self-Test in Collaboration with the NIH ITAP

Siemens' CLINITEST Rapid COVID-19 Antigen Self-Test delivers results in 15 minutes.

If your email program has trouble displaying this email, view as a webpage. FDA Authorizes an Additional COVID-19 Over-the-Counter Test Based on Data from the NIH Independent Test Assessment Program The U.S. Food and Drug Administration (FDA) authorized an additional over-the-counter (OTC) COVID-19 antigen test, where validation data were gathered through the FDA's collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The emergency use authorization (EUA) of Siemens' CLINITEST Rapid COVID-19 Antigen Self-Test is another example of the FDA's commitment to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating access to these tests for all Americans. This follows the recent authorization of the SD Biosensor, Inc. COVID-19 At-Home Test, distributed by Roche Diagnostics, which was also evaluated through the NIH ITAP. The CLINITEST Rapid COVID-19 Antigen Self-Test is an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. The test can be used as: A single test for people with COVID-19 symptoms. A serial test for people without symptoms, meaning the test is done two times over three days. The test can be used for people: Age 14 years or older with a self-collected nasal swab sample. Age 2 years or older when an adult collects the nasal swab sample. Read More Questions? If you have questions about OTC COVID-19 tests, see Coronavirus Disease 2019 Testing Basics.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA