FDA

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

By MedTech Intelligence Staff
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FDA

Lucira Health’s single-use molecular test kit will be available for prescription home use in people age 14 and older.

FDA has issued an emergency use authorization (EUA) for the first at-home rapid COVID-19 test. Available by prescription only, the single-use molecular test kit can provide SARS-CoV2 detection in 30 minutes or less. The test is authorized for use in people age 14 and older and is also authorized for use in doctor’s offices, urgent care centers and hospitals. Within hospitals the test can be used for patients of all ages but a healthcare provider must collect a sample at the point of care in patients 13 and younger.

The test involves taking a nasal swab sample, which is swirled in a vial that is placed in the test unit. Positive or negative results are displayed on the test unit’s light-up display in 11 to 30 minutes.

A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” said Jeff Shuren, M.D., director of CDRH in an agency news release. “Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them. We look forward to proactively working with test developers to support the availability of more at-home test options.”

Reporting results is another critical part of at-home testing. “Prescribing healthcare providers are required to report all test results they receive from individuals who use the 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 healthcare provider instructions to assist with reporting,” according to the FDA release.

Read the FDA EUA authorization letter sent to Lucira Health, Inc.

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