Rapid SARS-CoV-2 Detection Using the Lucira™ Check It COVID-19 Test Kit

Area of Science:

• Infectious Diseases
• Molecular Diagnostics
• Public Health

Background:

• The COVID-19 pandemic necessitates rapid, reliable diagnostic tools.
• Polymerase Chain Reaction (PCR) tests are accurate but not always accessible.
• There is a need for convenient, low-cost, and fast SARS-CoV-2 detection methods.

Purpose of the Study:

• To evaluate the clinical sensitivity and specificity of the Lucira™ Check It COVID-19 Test kit.
• To compare the performance of the Lucira test against RT-PCR for SARS-CoV-2 detection.
• To assess the utility of an at-home isothermal amplification test for early COVID-19 identification.

Main Methods:

• The study analyzed 190 nasopharyngeal samples collected between January and October 2021.
• Samples were tested using the Lucira™ Check It COVID-19 Test (isothermal amplification) and RT-PCR.
• Clinical sensitivity and specificity were calculated by comparing Lucira results with RT-PCR.

Main Results:

• The Lucira test demonstrated high concordance with RT-PCR, correctly identifying all negative samples.
• Clinical sensitivity was 91.1% for all positive RT-PCR samples and 93% for symptomatic participants.
• A significant positive correlation (R = 0.8612, p < 0.0001) was observed between RT-PCR cycle threshold (Ct) and Lucira time-to-positivity.

Conclusions:

• The Lucira™ Check It COVID-19 Test is a clinically validated, sensitive, and specific diagnostic tool for SARS-CoV-2.
• Its ease of use and speed make it a valuable option for at-home testing.
• Implementing such portable and affordable assays can significantly contribute to controlling the COVID-19 transmission chain.