WASHINGTON (NewsNation Now) — The first COVID-19 diagnostic test that can be used for self-testing at home was approved Tuesday night by the U.S. Food and Drug Administration.
The rapid results test created by Lucira was approved using an Emergency Use Authorization. According to the FDA, it’s made for those 14 and older who are suspected of having COVID-19 by their health care provider. It will be authorized for prescription use only.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. in a statement.
According to Lucira’s website, the COVID-19 All-In-One Test Kit is first inserted by putting a swab in your nose and stirring into a sample vial.
The device takes 30 minutes or less to provide a result of the presence of the SARS-CoV-2 virus.
According to the company’s website, the test is “intended to cost less than $50” and is manufactured in the U.S.
It’s unclear how accurate the test is, but the FDA says “negative results do not preclude an individual from SARS-CoV-2 infection,” and if someone still experiencing COVID-like symptoms, they should follow up with their health care provider.
Prescribing health care providers are also required to report all test results to the FDA.
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This is a developing story.