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

• Published in: Scientific reports 2022-04, Vol.12 (1), p.5729-5729, Article 5729
• Main Authors: DeFina, Samuel M., Wang, Jianhui, Yang, Lei, Zhou, Han, Adams, Jennifer, Cushing, William, Tuohy, Beth, Hui, Pei, Liu, Chen, Pham, Kien
• Format: Article
• Language: English
• Subjects: 631/1647/2017/2003; 692/700/139/422; Communicable Disease Control; Coronaviruses; COVID-19; COVID-19 - diagnosis; COVID-19 Testing; Diagnostic tests; Diagnostic Tests, Routine; Humanities and Social Sciences; Humans; Laboratories; Laboratory tests; Molecular Diagnostic Techniques - methods; multidisciplinary; Nucleic Acid Amplification Techniques - methods; Pandemics; Polymerase chain reaction; Public health; Reverse transcription; RNA, Viral - analysis; RNA, Viral - genetics; Saliva; Saliva - chemistry; SARS-CoV-2 - genetics; Science; Science (multidisciplinary); Sensitivity analysis; Sensitivity and Specificity; Severe acute respiratory syndrome coronavirus 2
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-022-09718-4

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.