FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for a rapid COVID-19 test developed by Abbott Laboratories. This is the first antigen test where results can be read directly from the testing card. This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer.
How It Works
A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.
Where It Can Be Used
This test could be used at point-of-care settings, like a doctor’s office, emergency room or some schools. This test has been authorized for use in patients suspected of 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 made broadly available. According to the test manufacturer, Abbott, it plans to make up to 50 million tests available monthly in the U.S. at the beginning of October 2020.
Expert warns of low sensitivity of rapid tests
In general, antigen tests are very specific, but are not as sensitive as molecular tests. The FDA said a negative test result from the new test may need to be confirmed with a molecular test before making treatment decisions.
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