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. 2022 Aug 3;12(8):1877.
doi: 10.3390/diagnostics12081877.

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

Maya Zahavi  1   2 , Hanan Rohana  1 , Maya Azrad  1 , Bracha Shinberg  1 , Avi Peretz  1   2
Affiliations

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

Maya Zahavi et al. Diagnostics (Basel). .

Abstract

The need for the early identification of SARS-CoV-2 has let to a quest for reliable tests that meet the standards of polymerase chain reaction (PCR) tests, on the one hand, and are low-cost, easy-to-use, and fast, on the other hand. One such test is the Lucira™ Check It COVID-19 Test kit (“Lucira”) (Lucira Health, Inc., Emeryville, CA, USA), which utilizes real-time loop-mediated isothermal amplification technology, developed for at-home use. This study evaluated the clinical sensitivity and specificity of Lucira in identifying the virus in 190 nasopharyngeal samples collected between January and October 2021. Each sample was also subjected to RT-PCR. All negative RT-PCR results were paralleled by a negative Lucira result. Out of 90 participants who had a positive RT-PCR result, 82 (91.1%) tested positive by Lucira. Among the 72 symptomatic participants, 67 (93%) tested positive by Lucira. All samples with a positive RT-PCR result with a threshold cycle (Ct) > 36, yielded a negative Lucira result. In addition, a significant positive correlation was found between Ct and time-to-positivity with Lucira (R = 0.8612, p < 0.0001). The implementation of such a portable and affordable assay may aid in breaking the COVID-19 transmission chain.

Keywords: COVID-19; LAMP; Lucira; kit performance; rapid diagnosis.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Lucira™ Check It COVID-19 Test kit.
Figure 2
Figure 2
Distribution of Ct values of RT-PCR positive results. Blue bars represent samples of patients for which both the Lucira kit and RT-PCR were positive. Orange bars represent patient samples for which the Lucira kit gave a negative result (Ct value > 36).
Figure 3
Figure 3
Comparison of Ct values of samples with RT-PCR-positive results between patients with a RT-PCR+/Lucira− results and patients with PCR+/Lucira+ results. The lines represent the mean Ct value.
Figure 4
Figure 4
Distribution of Ct values (RT-PCR) against time-to-positivity (Lucira). The blue dots represent samples of symptomatic patients and the orange dots represent samples of asymptomatic patients.
See this image and copyright information in PMC

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