The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Lucira Health’s COVID-19 & Flu Test for use in point-of-care settings.
The nucleic acid amplification test (NAAT)/molecular test has been developed for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B viral RNA.
It uses a single anterior nasal swab sample collected from people aged two years and above, who are suspected of having a respiratory viral infection by their healthcare provider, to test for Covid-19 and all its variants of concern as well as Flu A and Flu B.
The PCR Lab-quality test provides positive results in as little as 11 minutes, while a negative result takes 30 minutes.
Lucira Health stated that the combination test leverages the same platform and device design that is used in its FDA-authorised and commercialised Covid-19 test.
The Lucira COVID-19 & Flu Test has shown a similar performance in clinical trials compared to other high-sensitive lab-based PCR assays.
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Lucira Health president and CEO Erik Engelson said: “Covid-19 and flu viruses can both cause serious illness with similar symptoms, but each has unique prescription treatments that require diagnosis early in the infection to be effective.
“The inaccuracy of antigen Covid-19 tests makes such tests inadequate to use for early differential diagnosis of flu versus Covid-19.
“Clinicians can now facilitate simultaneous rapid testing at a mass scale to get patients on the path to recovery quickly.”
The single-use RT-LAMP test kit is designed to fit in the palm of a hand and runs on two AA batteries.
It also eliminates the need to separately purchase and maintain any reader or instrument.
Additionally, it is claimed to be the first combination test in a pipeline of other multiple assay tests that use the Lucira technology platform to multiplex from a single sample.