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Abstract
Saliva specimens have drawn interest for diagnosing respiratory viral infections due to their ease of collection and decreased risk to healthcare providers. However, rapid and sensitive immunoassays have not yet been satisfactorily demonstrated for such specimens due to their viscosity and low viral loads. Using paper microfluidic chips and a smartphone-based fluorescence microscope, we developed a highly sensitive, low-cost immunofluorescence particulometric SARS-CoV-2 assay from clinical saline gargle samples. We demonstrated the limit of detection of 10 ag/μL. With easy-to-collect saline gargle samples, our clinical sensitivity, specificity, and accuracy were 100%, 86%, and 93%, respectively, for n = 27 human subjects with n = 13 RT-qPCR positives.
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1 Department of Biomedical Engineering, The University of Arizona , Tucson, AZ 85721 , USA
2 Department of Biosystems Engineering, The University of Arizona ,Tucson, AZ 85721, USA
3 Department of Ecology and Evolutionary Biology, The University of Arizona , Tucson, AZ 85721 , USA
4 Department of Immunobiology, The University of Arizona College of Medicine ,Tucson, AZ 85724, USA