COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues First EUA for At-Home COVID-19 Test

FDA maze of regulations
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Big milestone in COVID-19 testing reached as at-home test becomes first of its kind to achieve FDA authorization

The US Food and Drug Administration (FDA) announced Nov. 17, 2020, that an at-home COVID-19 test has received an emergency use authorization (EUA). This is a significant milestone in COVID-19 testing, and it is the first time that a completely at-home test for COVID-19 has been authorized by the FDA. There have been other tests that have received EUAs for at-home specimen collections, but until this recent announcement, fully at-home testing was not permitted.

The EUA was issued to Lucira Health, Inc., for its Lucira COVID-19 All-In-One Test Kit. The test uses loop-mediated isothermal amplification (LAMP) to detect SARS-CoV-2 RNA (indicated by color change) for individuals with known or suspected COVID-19. The test has been authorized for point-of-care (POC) testing in addition to at-home use.

“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, MD, adding that the action “underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

According to information in the EUA letter, the Lucira COVID-19 All-In-One Test Kit includes the following materials or other authorized materials: sterile nasal swab, sample vial, test unit, batteries, plastic disposal bag. Lucira has indicated that availability of this test may be more limited, and the test may not be available nationally until spring 2021.

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