COVID-19 test chip for simultaneous detection of SARS-CoV-2 and antibodies using a single non-invasive sputum sample

We propose a rapid COVID-19 test integrated within a mass-producible microfluidic chip that automates all fluidic operations, from reagent delivery and incubation to signal readout, without external equipment and power. The test uses a single self-collected, non-invasive sample by coughing, to simultaneously (1) detect the viral particles in ~30 min, and (2) quantitatively measure host generated antibodies in ~10 min, with a single simple operation like a pregnancy test. While PCR detects RNA packaged in the matured virus, our test detects directly the viral particle, resulting in a simplified test without the need for nucleic acid extraction, while potentially increasing sensitivity. Combined with host-generated antibody measurement, our test can detect active and past infections, and those that would have been missed by PCR. Our solution strikes a balance between established technologies and innovation to meet the short timelines. With our industrial partner Sensoreal Inc. specializing in mass production and commercialization of chip-based diagnostic devices, our research is designed to address manufacturing and regulatory challenges for rapid scale-up and deployment. While 3D printing allows rapid development and testing with patient samples, Sensoreal has strong interest to further develop the validated test toward mass-production to thousands chips per day. We expect this project will lead to the fastest test that is low-cost, easy-to-use and non-invasive. Validation using patient samples will be pursued upon completion of this 6-month project along with application for regulatory approval. This test, being instrumentation-free and high-throughput, could accelerate widespread testing, rapidly identify infected individuals, including asymptomatic ones, and thus determine the true scope of the pandemic.