The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for Lucira Health’s Covid-19 diagnostic test for self-testing at home.
The molecular, single-use Lucira COVID-19 All-In-One Test Kit can potentially detect the SARS-CoV-2 virus that causes Covid-19.
It is the first test authorised for home use with self-collected nasal swab samples in people aged 14 or above suspected of Covid-19 by their healthcare provider.
Lucira Health CEO Erik Engelson said: “Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests and considered the ‘gold standard’ for determining if someone is infected.”
In addition, the test can be used in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centres, and emergency rooms for all ages.
In POC settings, the sample collection must be carried out by a healthcare provider to test individuals aged younger than 14.
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The test works by swirling the self-collected sample swab in a vial, which is later placed in the unit.
It includes simple swab, stir, and detect design and showed that 100% of patients were able to perform the test during trials in approximately two minutes.
Currently, the test is authorised for prescription use only and can yield a positive or negative result that can be read directly from its unit’s light-up display within 30 minutes.
FDA commissioner Stephen Hahn said: “While Covid-19 diagnostic tests have been authorised 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.”