US-based medical technology company Lucira Health confirmed that its Covid-19 All-In-One Test Kit is capable of detecting the ‘double mutant’ variant of SARS-CoV-2.
The double mutant variant was first identified in India on 24 March 2021 and was found in California on 25 March 2021, by Stanford Clinical Virology Lab scientists.
Designed and manufactured in the US, the LUCIRA Covid-19 All-In-One Test Kit is an FDA-authorised, prescription, molecular diagnostic test for Covid-19.
It is the first diagnostic test that can be completely self-administered by patients at home or used in a physician’s office, and delivers test results on-the-spot, said the company.
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.
“As sequences from new virus strains become available, we compare their genetic code with our test using a well-established, extremely accurate computer model.”
LUCIRA Covid-19 All-In-One Test Kit is designed to fit in the palm of a hand and works similar to PCR lab tests, by extracting genetic material from the virus and amplifying it.
Users will receive the test device, two AA batteries, sample vial, swab and instructions.
Once batteries are inserted into the device and the sample vial is placed in the test unit, user has to collect the sample by rotating the swab in each nostril five times.
The swab is then stirred in the sample vial, and the vial is then gently pressed into the test unit, which delivers the results within 30 minutes.
Results produced using LUCIRA Covid-19 All-In-One Test Kit were compared with the Hologic Panther Fusion, a high sensitivity molecular test, in a community-based clinical trial.
In the test, Lucira’s molecular test obtained a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA).
Mitra added: “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. It’s complex work, but really important since users rely on our test for accurate results.”
“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.”
