The COVID-19 pandemic represents a worldwide infectious disease challenge that disrupted our economic, educational, and social norms in a way that was largely unimaginable just months ago. At present the most efficacious method of limiting the spread of the disease has been to test those that exhibit symptoms ? typically by nucleic acid based viral identification methods ? and isolate those that are positive. Even at this early stage this approach has put significant strain on the diagnostic infrastructure of advanced countries, let alone those with fewer resources. As we move beyond symptom-initiated confirmation diagnoses to the larger scale screening that may be required to identify asymptomatic carriers and to restart sections of our economy, much more rapid and higher throughput techniques will be required. Under ongoing NIH/NCI UH2/UH3 (UH3CA202723) funding we have been developing TINY (Tiny Isothermal Nucleic acid quantification sYstem). The TINY system is a self-contained, portable device for the detection and LAMP-based quantification of viral nucleic acids designed for use in settings with limited resources. Through that program, the system is currently deployed within Uganda for identifying Kaposi?s Sarcoma Herpes Virus (KSHV) in human biopsies as a novel diagnostic technique for Kaposi?s Sarcoma. The system has been validated on over 500 samples showing sensitivity and specificity of 93% and 95%. Through this supplement request, we propose to upscale the TINY system to enable much high-throughput screening ? from 6 parallel samples to 96 - and adapt it to a run a recently developed LAMP assay for SARS- CoV-2 detection which has already been validated on 182 patients in New York City. We believe that this will simultaneously contribute to the need for higher throughout COVID-19 diagnostics and advance the NCIs desire for platforms that can enable broader screening for viruses which are known to cause cancers (e.g. HPV in the case of cervical cancer).
We propose adapt our existing portable diagnostic platform to enable high-throughput screening of SARS-CoV- 2, the causative virus behind COVID-19. Under NCI funding this system is currently deployed to detect the virus that causes Kaposi?s Sarcoma. Success in this project will enable faster screening of individuals for SARS-CoV- 2 and advance the NCIs desire for platforms that can enable broader screening for viruses which are known to cause certain cancers.
