Description

The Lucira Check It COVID-19 Test Kit is a single-use test kit intended for the qualitative detection of nucleic acid from the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is for nonprescription home use with self-collected anterior nasal (nasal) swab specimens in individuals aged 14 years and older (self-collected) or individuals ≥2 years (collected by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. 

Features

• First and only FDA authorized single-use molecular home test
• Results in 30 minutes or less
• On-demand access to telehealth for positive results
• Authorized for self-collection for individuals aged 14+ and adult collection for children aged 2-13
• Detects all COVID-19 variants of interest and concern, including Omicron and all BA and BQ subvariants of concern

Kit Contents

• Package Insert
• Nasal Swab: one sterile nasal swab in a peel-pouch
• Sample Vial: a single-use, disposable vial containing an elution buffer to release and lyse virions from a nasal swab sample
• Test Unit: a single-use, disposable unit with lyophilized reagents for multiplexed amplification and electronic readout for detection of SARS-CoV-2 RNA
• Batteries: two AA batteries for the Test Unit
• Plastic disposal bag to dispose of the test kit after use.

Performance Measures

• 92% Sensitivity
• 98% Specificity