RAPID: Nanomembranes for the Rapid Detection of SARS-CoV-2 in Biofluids

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This RAPID project is poised to develop a fast and inexpensive test to detect active infections of the novel coronavirus, SARS-CoV-2, responsible for the global COVID-19 pandemic. The high costs of available rapid testing strategies limit their use in population-based screening, particularly in the most vulnerable low-resource communities. In contrast, the test developed here will be relatively inexpensive because it requires neither external power nor additional sample preparation and analysis instrumentation. The test will be tuned to detect the entire range of viral loads observed in individuals with active infections. The project team aims to both design the prototype device and establish proof-of-principle within the first three months of the project. To do so, a diverse and multidisciplinary team including six graduate students, a post-doctoral fellow, a medical doctor, two undergraduate students, and two U.S.-based manufacturers will be mobilized. The project will provide a profound humanitarian and educational experience for the trainees as they work quickly but deliberately to demonstrate the feasibility of a COVID-19 test device urgently needed throughout the world. The overall goal of the proposal is to create a manufacturable microfluidic device capable of instantaneous diagnosis of active COVID-19 infections from nasal mucus or phlegm. The microfluidic device will employ ultrathin silicon 'nanomembranes' to identify the presence of SARS-CoV-2 spike proteins in the biofluid sample. Samples without the SARS-CoV-2 virus or with viral particles smaller than SARS-CoV-2 will not register a positive result. Modifications to the investigators' prior flow cell device designs will be made to ensure the two flow paths can be driven by the surface tension of the applied sample alone. The investigators have contracted with two U.S.-based companies for high-throughput manufacturing of the device components. Proof-of-concept demonstration will be conducted with nanoparticle SARS-CoV-2 surrogates and non-SARS-CoV2 spike protein controls. Studies will be conducted to define the sensitivity and specificity of the device, minimizing false negatives. Device manufacturing will be done using high-throughput strategies that can be readily translated to high-volume commercial manufacturing. A successful platform will be tested with samples from COVID-19 patients at a New York State flu center run by the University of Rochester.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.