Lucira Covid-19 All-In-One Test Kit has the capability to extract genetic material from the virus and amplify it similar to PCR lab tests
Lucira Health’s molecular test kit has the potential to detect double mutant variant of Covid-19. (Credit: PIRO4D from Pixabay)
Medical technology firm Lucira Health has confirmed that its molecular test kit has successfully detected the double mutant variant of Covid-19.
The double mutant variant was first detected in India on 24 March and identified in California on 25 March, by Stanford Clinical Virology Lab scientists.
The variant features two genetic mutation sequences that is being tracked by the Centre for Disease Control (CDC).
The Lucira Covid-19 All-In-One Test Kit has the potential to extract genetic material from the virus and amplify it similar to PCR lab tests.
According to the company, each Lucira test kit includes test device, two AA batteries, sample vial and swab, providing all that is needed to run one Covid-19 test.
The Lucira Covid-19 All-In-One Test Kit results have been compared with the Hologic Panther Fusion in a community-based clinical trial. Lucira demonstrated a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA) in the trial.
Lucira health chief technology officer and co-founder Dr Debkishore Mitra said: “Our focus is on providing a test that’s easy for an individual to use and extremely accurate. If someone uses our ‘gentle swab’ test and has Covid-19, they can know in as few as 11 minutes on-the-spot.
“If they are not infected, they will know within 30 minutes. Precision and performance matter, and we can’t afford to let any variants escape detection.”
The company has designed to offer a clinically relevant Covid-19 result within 30 minutes from sample collection.
In November last year, Lucira secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its at-home self-testing Covid-19 diagnostic kit.
The authorisation also facilitated the use of the test in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but samples are be collected by a healthcare provider.