Lucira Health has confirmed that its COVID-19 All-In-One Test Kit can successfully detect the ‘double mutant’ SARS-CoV-2 variant.
The US Food and Drug Administration (FDA)-authorised, prescription, molecular diagnostic Covid-19 test can be fully administered by the patient in an at-home setting or used in a doctor’s office.
Like PCR lab tests, Lucira’s test extracts viral genetic material and amplifies it. The kit contains a test device, which fits in the palm of the hand, sample vial, swab, two AA batteries and simple instructions.
To use it, the customer opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial. Inserting the vial into the test unit initiates the test.
On commencing the test, a ‘ready’ light will blink until a ‘positive’ or ‘negative’ green light is illuminated within 30 minutes.
The ‘swab, stir and detect’ test platform has shown that 100% of users successfully carried out the test in under two minutes of hands-on time in usability testing. It can take two to 14 days to deliver similarly accurate results in the centralised laboratory testing environment.
Lucira Health chief technology officer and co-founder Debkishore Mitra said: “A test is only helpful if it can detect the virus it’s designed to find. That’s why we started routinely monitoring Covid-19 viral variants, even before the FDA’s voluntary guidelines were released this February.
“Since we began this monitoring, our Lucira test kit has been reactive to more than 99.9% of available Covid-19 viral sequences, which are roughly 30,000 letters long.”
“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.”
The double mutant variant was first detected in India on 24 March and was found in California, US, on 25 March by Stanford Clinical Virology Lab scientists. The double mutant variant has two genetic mutation sequences, as opposed to one in other variants.
Last November, the US FDA granted an emergency use authorization for Lucira Health’s Covid-19 diagnostic test for self-testing at home.