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Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in November 2020. The company said it hopes for its latest EUA ahead o…

Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]

Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in Novem…

FDA issues EUA for single-use, OTC PCR COVID-19 at-home test

Lucira Health announced today that it received FDA emergency use authorization (EUA) for over-the-counter sales of its COVID-19 test kit.

Emeryville, Calif.-based Lucira’s PCR molecular test kit, the Lucira Check It kit, is designed to deliver results in 30 minutes or less at home. The authorization covers those with symptoms and those without, and the test kit can be ordered for $55, according to a news release.

The company’s COVID-19 testing kit was the first to receive EUA for at-home use back in November, although that authorization was for prescription use only. The latest authorization drastically expands the availability of the test. It follows the FDA’s recent authorizations of the BinaxNow Ag card from Abbott (which includes point-of-care screening) and the Quidel Quick-View at-home test for OTC use.

Each Lucira test kit can detect a positive result in as few as 11 minutes or confirm a negative result within 30 minutes, the com…

5 at-home COVID-19 diagnostic tests you should know

The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home.

The agency has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms are advised to follow up with their healthcare providers as a negative result does not rule out a SARS-CoV-2 infection.

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5 at-home COVID-19 diagnostic tests you should know

[Image from unsplash.com]

A year into the COVID-19 pandemic, the wait for a completely at-home COVID-19 test ended when the FDA authorized the first ones in November to enable people to obtain samples and results at home.

The FDA has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms …