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Sci Rep . SaliVISION: a rapid saliva-based COVID-19 screening and diagnostic test with high sensitivity and specificity

tetano

Editor, Senior Moderator
Sci Rep


. 2022 Apr 6;12(1):5729.
doi: 10.1038/s41598-022-09718-4.
SaliVISION: a rapid saliva-based COVID-19 screening and diagnostic test with high sensitivity and specificity


Samuel M DeFina[SUP] 1 [/SUP], Jianhui Wang[SUP] 1 [/SUP], Lei Yang[SUP] 1 [/SUP], Han Zhou[SUP] 1 [/SUP], Jennifer Adams[SUP] 2 [/SUP], William Cushing[SUP] 3 4 [/SUP], Beth Tuohy[SUP] 5 [/SUP], Pei Hui[SUP] 1 [/SUP], Chen Liu[SUP] 6 [/SUP], Kien Pham[SUP] 7 [/SUP]



Affiliations

Abstract

The Coronavirus disease 2019 (COVID-19) pandemic-caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)- has posed a global threat and presented with it a multitude of economic and public-health challenges. Establishing a reliable means of readily available, rapid diagnostic testing is of paramount importance in halting the spread of COVID-19, as governments continue to ease lockdown restrictions. The current standard for laboratory testing utilizes reverse transcription quantitative polymerase chain reaction (RT-qPCR); however, this method presents clear limitations in requiring a longer run-time as well as reduced on-site testing capability. Therefore, we investigated the feasibility of a reverse transcription looped-mediated isothermal amplification (RT-LAMP)-based model of rapid COVID-19 diagnostic testing which allows for less invasive sample collection, named SaliVISION. This novel, two-step, RT-LAMP assay utilizes a customized multiplex primer set specifically targeting SARS-CoV-2 and a visual report system that is ready to interpret within 40 min from the start of sample processing and does not require a BSL-2 level testing environment or special laboratory equipment. When compared to the SalivaDirect and Thermo Fisher Scientific TaqPath RT-qPCR testing platforms, the respective sensitivities of the SaliVISION assay are 94.29% and 98.28% while assay specificity was 100% when compared to either testing platform. Our data illustrate a robust, rapid diagnostic assay in our novel RT-LAMP test design, with potential for greater testing throughput than is currently available through laboratory testing and increased on-site testing capability.
 
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