Lucira Check It COVID-19 Test Kit

Description

The Lucira Check It COVID-19 Test Kit provides PCR-quality accuracy in 30 minutes or less. It's the first and only FDA authorized single-use rapid molecular test available over the counter.

• PCR-Quality Accurate Results You Can Trust: Symptoms or not, Lucira Check It is 98% accurate at detecting SARS-CoV-2 compared to one of the best lab PCR tests.¹
• Molecular Test, Not an Antigen Test: Like lab-based PCR tests, this test amplifies virus genetic material for accurate, early detection.
• Easy to Use, Rapid Results: Includes a shallow nasal swab with easy-to-follow instructions. Results anytime, anywhere in 30 minutes or less.
• Detects Omicron Variant: Lucira surveillance testing shows reactivity to Omicron and Delta, in addition to alpha, beta, gamma, lambda, and mu variants.
• LUCI PASS, Your Digital Verified Test Result: Text “LUCI” to 44544 after your test to get a downloadable Lucira COVID-19 test result on your phone for travel, work, school, and events.
• For Ages 2 to Adult: The self-test is authorized for children ages 2 to 13 when administered by an adult, and for self-administration in ages 14 and older.

1. Excluding samples with very low levels of virus (>37.5 Ct), Lucira Community Testing Study 07A-CLI 006 Fall 2020 and Lucira Community Testing Study 07A-CLI 007 Winter 2021 (n=394).

Specifications

• Accuracy: 98%
• CPT Code: 87635
• Description: Molecular COVID Testing Kits, OTC
• Clia Complexity: Waived (FDA, EUA)
• Detectable Analytes: SARS-CoV-2
• Detection Method: RT-LAMP
• DoA Calibrators: No
• Format: In vitro Diagnostic Test
• Sample Type: Nasal
• Sensitivity: 97%
• Type: Molecular COVID Testing Kit
• Disposable: Single-use
• Includes: 2 AA batteries, test unit (pouch 1), sample vial (pouch 2), swab (labeled 3) and plastic disposal bag
• Specificity: 98%
• Sterility: Sterile
• Test Time: Results in 30 minutes or less

The Lucira COVID-19 Test Kit has not been FDA cleared or approved but has been authorized for emergency use under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.