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Field-deployable, rapid diagnostic testing of saliva for SARS-CoV-2 #MMPMID33750853
Wei S; Suryawanshi H; Djandji A; Kohl E; Morgan S; Hod EA; Whittier S; Roth K; Yeh R; Alejaldre JC; Fleck E; Ferrara S; Hercz D; Andrews D; Lee L; Hendershot KA; Goldstein J; Suh Y; Mansukhani M; Williams Z
Sci Rep 2021[Mar]; 11 (1): 5448 PMID33750853show ga
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 microl 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.
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Sci+Rep 2021 ; 11 (1): 5448
