Evaluation, Validation, and Implementation of Acoustic Droplet Ejector Technology

DESCRIPTION (provided by applicant): Clinical diagnostic laboratories determine the presence, or absence, of viruses, parasites, bacteria, or fungi in biological specimens submitted under physicians' order for testing. The medical field has estimated that over 70% of all health care decisions are based upon laboratory test results. As a result, assays must be thoroughly validated, both clinically and analytically, to permit such important, sometimes life-saving, decisions. Equally important to the reliability of the results is the timeliness in which they can be provided; the quick administration of proper medicinal treatments is a requisite to alleviating patient morbidity and reducing mortality. The focus of this innovative grant proposal is to integrate non-contact (no pipette tips required) acoustic droplet ejector (ADE) technology, which essentially uses focused sound waves to transfer aqueous solutions from one location to another, into a clinical diagnostic laboratory workflow. To do so, we will (1) enhance our in-house developed laboratory information software to support the new technology, (2) miniaturize, reformat, and re-validate our most popular molecular detection assays, and (3) train all required personnel to introduce this technology into an operational Clinical Laboratory Improvement Amendments (CLIA)-accredited diagnostic laboratory. In addition to significantly increasing our sustainability and efficiency while decreasing the associated turnaround time of needed diagnostic test results to improve human health, numerous internal benefits would be achievable such as significant cost savings due to a miniaturization process and improved environmental policies from decreased plastic consumption. The successful completion of this project is the first step in our pursuit towards three distinct commercialization directives to: (1) create novel, modularized, ADE technology-based, high-throughput molecular diagnostic laboratories, (2) develop and manufacture validated out-of-the-box diagnostic test products which, when coupled with specialized software that we would produce, can be performed utilizing the ADE systems, and (3) upgrade existing diagnostic laboratories to utilize and benefit from ADE technology. PUBLIC HEALTH RELEVANCE: Physicians rely upon molecular-based diagnostic assays to diagnose and treat their patients. To aid these health care professionals and improve the quality-of-life of their patients, we seek to improve the turnaround time and reliability of laboratory test results by incorporating acoustic droplet ejector (ADE) technology, which uses focused sound waves to transfer aqueous solutions from one location to another, into our clinical laboratory workflow. This research will provide the foundation for the generation of three novel, targeted commercial products: (1) modular, high-throughput, ADE technology-based, state-of-the-art molecular diagnostic laboratories, (2) specialized molecular out-of-the-box diagnostic kits optimized for use with ADE systems, and (3) upgrade services and licensable software products to introduce ADE technology into existing molecular diagnostic laboratories.