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FDA Authorizes First At-Home COVID-19 Self Test

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The U.S. Food and Drug Administration has authorized the first COVID-19 diagnostic at-home self test that provides results in 30 minutes or less.

The Lucira COVID-19 All-In-One Test Kit by Lucira Health, Inc., a single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, has received FDA's emergency use authorization or EUA.

The Lucira test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. The test until now was authorized for prescription use only.

The test can also be used in point-of-care or POC settings, e.g., doctor's offices, hospitals, urgent care centers and emergency rooms, for all ages. However, to test individuals younger than 14 years old, a healthcare provider must collect the samples.

The Lucira test, which works by swirling the self-collected sample swab in a vial that is then placed in the test unit, provides results in 30 minutes or less.

The test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19.

One can read the results directly from the test unit's light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. The FDA urged individuals with positive results to self-isolate and seek additional care from their health care provider.

The prescribing health care providers are required to report all results from the Lucira test to their relevant public health authorities in accordance with local, state and federal requirements.

Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.

FDA Commissioner Stephen Hahn said, "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."

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