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New All-in-One COVID-19 Test Kit Identifies 99.9% of All Known SARS-CoV-2 Strains

By LabMedica International staff writers
Posted on 12 Apr 2021
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Image: LUCIRA COVID-19 All-In-One Test Kit (Photo courtesy of Lucira Health, Inc.)
Image: LUCIRA COVID-19 All-In-One Test Kit (Photo courtesy of Lucira Health, Inc.)
A COVID-19 molecular test kit can successfully identify the “double mutant” variant of the SARS-CoV-2 virus.

Lucira Health, Inc.’s (Emeryville, CA, USA) single-use COVID-19 All-In-One Test Kit has been found to be reactive to at least 99.9% of all known SARS-CoV-2 strains. The “double mutant” variant was first identified in India on March 24, 2021, and found in California on March 25, 2021, by Stanford Clinical Virology Lab scientists. Unlike other variants, it has two genetic mutation sequences that the Center for Disease Control (CDC) is tracking. Variants occur when viruses replicate themselves and include well-known strains first discovered in the UK, South Africa, and Brazil. Variants can occur when the genetic code packaged inside the virus starts copying itself and the new copies inadvertently start replicating a new, mutant code. These errors can cause a virus to elude the immune system and become more challenging to detect.

The targeted, molecular amplification that LUCIRA COVID-19 All-In-One Test Kit and PCR tests employ makes them demonstrably more sensitive and reliable than “rapid” antigen tests, which can miss active COVID-19 infections. The LUCIRA COVID-19 All-In-One Test Kit Test Kit fits in the palm of a hand, extracts genetic material from the virus and amplifies it similar to PCR lab tests. Each Lucira test kit contains everything needed to run one COVID-19 test. Users get the test device, two AA batteries, sample vial, swab and simple instructions. The batteries are inserted into the device and the sample vial is placed in the test unit. The user then opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial, which is then gently pressed into the test unit to start the test. The “ready” light will blink until a “positive” or “negative” green light is illuminated within 30 minutes. Lucira’s easy-to-use ‘swab, stir and detect’ test platform demonstrated that 100% of users successfully performed the test in less than about two minutes of hands-on time in usability testing.

“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,” said Lucira Health Chief Technology Officer and co-founder Debkishore Mitra, Ph.D. “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,” Dr. Mitra added.

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Lucira Health, Inc.

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