The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Lucira Check It™ COVID-19 test kit (Lucira Health, Inc), an over-the-counter (OTC) single-use molecular test to detect COVID-19 in individuals with or without symptoms.
The Lucira Check It COVID-19 test kit utilizes a molecular amplification technology to detect SARS-CoV-2 RNA. The EUA allows for nasal swab samples to be self-collected at home by an individual 14 years of age and older or by an adult from an individual 2 to 13 years of age.
Each test kit includes the test device, sample vial, nasal swab, and 2 AA batteries to run 1 COVID-19 test. After the nasal swab is rotated in each nostril 5 times, the swab is stirred in the sample vial, which is then pressed into the test unit. The “ready” light will blink until a “positive” or “negative” green light is illuminated. Results are provided as quickly as 11 minutes for a positive result and 30 minutes for a negative result.
Findings from 2 Community Testing studies showed that the Lucira test was 98% accurate when compared with the FDA-authorized Hologic Panther Fusion PCR test; the comparative positive result agreement was 97% and the negative result agreement was 98%. Accuracy was observed to be 96% when 10 samples with very low viral loads were included in the data.
“We worked with more than 1000 people before starting our FDA clinical and usability studies. Our goal was to produce an easy-to-use test that provides PCR quality accuracy in a portable, intuitive, anytime, anywhere format,” said Lucira CEO Erik Engelson. “People are looking for ways to feel more certain in these uncertain times, and our Lucira CHECK IT test provides that.”
The Lucira Check It COVID-19 test kit is available from lucirahealth.com for $55.
FDA authorizes first single-use, PCR quality over the counter (OTC) LUCIRA CHECK IT™ COVID-19 at-home test. Available now. [press release]. Emeryville, CA: Lucira Health, Inc.; April 12, 2021.