- Lucira’s COVID-19 test is the only EUA authorized rapid at-home self-test that delivers PCR accuracy and early detectability in a single-use test kit with results in 30 minutes
- Availability in the Optum Store expands access to this unique testing option amidst a surge of US COVID-19 cases caused by the Omicron variant
- Lucira’s test uniquely offers PCR accuracy and early detection without the 24 hour+ wait for results
EMERYVILLE, Calif., Jan. 11, 2022 (GLOBE NEWSWIRE) — Lucira Health, Inc. (“Lucira Health” or “Lucira”) (NASDAQ:LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, announced that its Lucira™ Check-It PCR-Quality, At-Home Molecular COVID-19 Test is now available in the Optum Store (store.optum.com).
“Expanding access to Lucira’s first-of-its-kind test is critical in the face of the current surge of COVID-19 cases. Our at-home molecular test delivers the lab-quality accuracy of PCR combined with the rapid, on-the-spot results of antigen tests, so you can detect early COVID-19 infection, including Omicron, before potentially putting others at risk,” said Erik Engelson, President and Chief Executive Officer of Lucira Health. “The Optum Store connects consumers with high-quality, affordable health products and services to improve their overall health and care, and we’re proud to offer our tests to their customers.”
The Lucira Check-It COVID-19 test kit has emergency authorization by FDA under EUA.
Lucira™ Test Kits
The Lucira™ Check-It (OTC) and All-In-One (Rx) test kits are molecular Nucleic-Acid Amplification Tests (referred to as NAAT). The tests fit in the palm of your hand, extract genetic material from the virus and amplify it, similar to PCR lab tests, to detect the presence of virus earlier and more accurately than antigen tests. The test uses an approach called reverse transcriptase loop-mediated isothermal amplification (“RT-LAMP”). It was designed and tested extensively for individuals to use independently and does not require a physician’s prescription or supervised assistance. There is no additional equipment to purchase, such as a reader or instrument.
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 five times in each nostril. 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 also offers a free LUCI Pass™ digital verified test result back to a user’s phone. LUCI Pass™ is accessed via text and does not require downloading an app. There is also an opt-in for public health reporting for users who wish to transmit their results to the relevant public health authorities.
In clinical trials, 100% of users successfully performed the test at home in about two minutes using Lucira’s easy-to-use ‘swab, stir and detect’ Check-It test kit.
In a community trial setting, Lucira™ Check-It results were compared with the Hologic Panther Fusion, considered a high-sensitivity molecular test due to its low Limit of Detection (“LOD”). Lucira’s accuracy was 98%, correctly detecting 385 out of 394 positive and negative samples in comparison to the Hologic Panther Fusion, excluding ten samples with very low levels of virus (those with very high PCR cycle thresholds of 37.5 or greater) that possibly no longer represented active infection. Comparative positive results agreed 97% of the time among this sample, and negative results agreed 98% of the time.
About Lucira Health
Lucira is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits. Lucira’s testing platform produces lab quality molecular testing in a single-use, consumer-friendly, palm-size test kit powered by two AA batteries. Lucira designed its test kits to provide accurate, reliable, and on-the-spot molecular test results anywhere and at any time. The Lucira™ Check-It COVID-19 Test Kit (OTC) and Lucira™ COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection. For more information, visit www.lucirahealth.com.