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

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.

Nucleic Acid Amplification‐Based Technologies (NAAT)—Toward Accessible, Autonomous, and Mobile Diagnostics

“…The test uses LAMP and works by swirling the self‐collected sample swab in a vial that is then placed in the test unit. [ 98 ]…”

“…The test uses LAMP and works by swirling the self-collected sample swab in a vial that is then placed in the test unit. [98] Cue Health, a San Diego-based company, provides a lower nasal swab test with results to a user's mobile smart device in ≈20 min. Presumed to utilize electrochemical readout with isothermal amplification, Cue Health test detects the RNA of SARS-CoV-2 with high specificity and displays the results on a user's device via Cue Health's phone app.…”

UbiNAAT: a multiplexed point-of-care nucleic acid diagnostic platform for rapid at-home pathogen detection

“…Its isothermal activity, which eliminates the need for thermal-cycling, plus the fact that the basic LAMP assay is off-patent, have made it a prime candidate for lowcost diagnostics and analysis for point-of-care implementation. [21][22][23][24] While LAMP assay sensitivity is generally lower than that of qPCR, 25,26 its compatibility with point-of-care device design has encouraged many groups to pursue LAMP-based diagnostics for infectious diseases.…”

“…30 Lucira Health initially developed an RT-LAMP POC platform for COVID testing, before expanding their test platform into a multiplexed platform that simultaneously detects SARS-CoV-2, influenza A, and influenza B. 24,31 Visby Medical's 3-assay POC respiratory panel for COVID, influenza A, and influenza B enabled qualitative detection of multiple respiratory illnesses from a single patient sample, which could be operated in a CLIA-waived setting. 28,29 These leading COVID POC tests currently enable 10 3 viral copy detection from a human nasal swab within 30 minutes, which has set the standard for COVID testing.…”

Post-Market Surveillance of Six COVID-19 Point-of-Care Tests Using Pre-Omicron and Omicron SARS-CoV-2 Variants

“…Molecular POCTs detect the presence of SARS-CoV-2-specific nucleic acid sequences through PCR or isothermic amplification techniques such as loop-mediated isothermal amplification (LAMP) (1,8,9). Molecular tests generally provide a high level of sensitivity and may detect viral RNA weeks after infection (9)(10)(11).…”