LLNL researchers have developed a high-volume, low-cost diagnostic test that is easy to use and provides results in under an hour. The testing platform will provide emergency responders and other medical professionals with the ability to screen individuals using oral and nasal samples, and obtain results in approximately 30 minutes. This point-of-care testing approach will enable rapid triage of a high volume of patients, without needing to send a sample to a laboratory for testing and then waiting for results. The easy-to-use, compact testing kit consists of a single, disposable tube, which is used throughout the process to collect samples from patients and obtain a positive or negative test result. Using this approach, where all items are contained in a fully sealed, disposable tube, reduces the risk of cross contamination via testing equipment. The diagnostic platform will include a built-in sampling swab attached to the tube’s cap, as well as a buffer that is loaded through a port in the cap, using a syringe. Once the buffer is loaded, the syringe is removed, and the device is sealed and heated isothermally to amplify the pathogen-specific DNA/RNA. Each tube also includes a reagent that is pre-loaded in the tube as a stabilized bead, ready to initiate a chemical reaction once the buffer is loaded. Test results are easy to read. Due to the presence of a colorimetric dye, there is a visible color change that indicates any positive results.
US Patents 9,315,858 “Apparatus for point-of-care detection of nucleic acid in a sample” and 9,222,126 “Methods for point-of-care detection of nucleic acid in a sample” (LLNL internal case # IL-12201A and IL-12208A respectively).