Abstract

Technology to Break the 10-minute Sample to Answer Barrier for Molecular Point of Care Diagnostics

Jacob Hambalek, Scientist, Autonomous Medical Devices Incorporated

Clinical utility for point of care (POC) testing is optimal when the test results are available in the timeframe of an office visit (~20 minutes). Today, sample to answer times for RT-PCR results at the POC range from 20 minutes to over an hour. My presentation will delve into the technologies AMDI has developed for its ultrafast RT-PCR system, which delivers a sub-10 minute sample to answer result for up to 32 different targets. This breakthrough was made possible by combining a novel hyperbaric heating (HBH) sample preparation method with an innovative approach to ultrafast, multiplex PCR thermocycling. HBH is a versatile, extraction-free sample prep method yielding PCR-ready material in 15 seconds. HBH is compatible with a diverse set of organism types and sample matrices and has achieved analytical sensitivity levels comparable to the more time consuming and labor intensive sample prep methods currently in use. Our ultrafast multiplex thermocycling approach maximizes conductive heat transfer without any reduction in reaction volume. When combined, both technologies enable a sub-10 minute sample to answer RT-PCR molecular result for up to 32 targets. Results from our system can be obtained promptly, with lab-quality sensitivity, and within the standard office visit timeframe.