PFI-TT: Clip-On Smartphone Biosensor for Mobile Health Diagnostics

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The broader impact/commercial potential of the Partnership for Innovation - Technology Translation (PFI-TT) project is to develop a single-step, 30 minute test for HIV viral load measurement with digital resolution and the capability to measure small amounts. This system is designed to be used by HIV patients with no laboratory expertise, which is currently not possible. The test will be conducted by an inexpensive clip-on instrument to test a blood sample; it uses the rear-facing camera of any modern smartphone to record video of the chemical reaction and measure special light signals. The test will measure the dangerous pathogens, including a way to correct for false positives and negatives; it also provides immediate display of results and shares the data with a cloud-based database. As HIV sensing in blood represents a challenging application with a large commercial market, a successful demonstration will pave the way toward a host of a wide array products and services for mobile sensing of many potential infections. The proposed project is to design, build, and rigorously validate a self-testing platform for digital-resolution quantitation of HIV within a droplet of serum. Currently, no self-testing approaches are currently able to detect HIV during peak viremia and transmissibility in acute infection. The proposed approach utilizes an inexpensive ($10) clip-on instrument that will enable the back-facing camera of any modern smartphone to function as a fluorescence microscope that illuminates and isothermally heats a silicon-based test cartridge that is pre-loaded with primers for Loop-Mediated Isothermal Amplification (LAMP) of HIV-specific nucleic acid sequences. The proposed technology will integrate several innovative elements to achieve the goal of a sample-to-answer test within 30 minutes, while achieving 1000 copies/ml detection limit by performing: 1. LAMP reactions within a low-autofluorescence silicon-based microfluidic cartridge pre-loaded with dried primers, and packaged for refrigeration-free storage. 2. Spatial LAMP (S-LAMP) analysis of the amplification reaction using video imaging of the process and automated image analysis to identify/count fluorescent-emitting LAMP initiation points. 3. Integration of positive and negative experimental control regions to ensure assay validity. 4. Chemical lysis of the sample prior to dispensing of LAMP buffer and the test sample into the paper test medium. 5. A clip-on instrument that makes an optical interface with any smartphone rear-facing camera.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.