Field-deployable, rapid diagnostic testing of saliva for SARS-CoV-2

Wei, Shan; Suryawanshi, Hemant; Djandji, Alexandre; Kohl, Esther; Morgan, Stephanie; Hod, Eldad A.; Whittier, Susan; Roth, Kevin; Yeh, Raymond; Alejaldre, Juan Carlos; Fleck, Elaine; Ferrara, Stephen; Hercz, Daniel; Andrews, David; Lee, Lilly; Hendershot, Kristopher A.; Goldstein, Joshua; Suh, Yousin; Mansukhani, Mahesh; Williams, Zev

To safely re-open economies and prevent future outbreaks, rapid, frequent, point-of-need, SARS-CoV-2 diagnostic testing is necessary. However, existing field-deployable COVID-19 testing methods require the use of uncomfortable swabs and trained providers in PPE, while saliva-based methods must be transported to high complexity laboratories for testing. Here, we report the development and clinical validation of High-Performance Loop-mediated isothermal Amplification (HP-LAMP), a rapid, saliva-based, SARS-CoV-2 test with a limit of detection of 1.4 copies of virus per µl of saliva and a sensitivity and specificity with clinical samples of > 96%, on par with traditional RT-PCR based methods using swabs, but can deliver results using only a single fluid transfer step and simple heat block. Testing of 120 patient samples in 40 pools comprised of 5 patient samples each with either all negative or a single positive patient sample was 100% accurate. Thus, HP-LAMP may enable rapid and accurate results in the field using saliva, without need of a high-complexity laboratory.