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 H igh- P erformance L oop-mediated isothermal Amp lification (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.
【저자키워드】 SARS-CoV-2, DNA, Assay systems, Infectious-disease diagnostics, 【초록키워드】 Saliva, diagnostic, RT-PCR, virus, Laboratory, clinical samples, Outbreaks, COVID-19 testing, Testing, Sensitivity and specificity, swabs, Patient, limit of detection, diagnostic testing, PPE, Swab, isothermal, transfer, positive, SARS-CoV-2 test, AMP, Prevent, clinical sample, transported, 【제목키워드】 diagnostic,