Rapid, Handheld, Point-of-Care Stool Sample-prep Device for the Extraction and Detection of Nucleic Acid from Diarrheal Pathogens - Abstract
Diarrheal disease is a major health issue worldwide resulting in nearly 500,000 deaths annually
in children under 5 years of age, mostly in the developing world. Those who survive have higher
risk of stunted growth and cognitive development. Identification of the gastrointestinal (GI)
pathogens that cause diarrheal disease helps guide effective treatment. Currently, in the
developed world, this is done using multiplexed PCR laboratory tests which are expensive, slow
and require a laboratory. Unfortunately, such laboratory tests are not available in remote and
resource limited regions in the developing world where mortality due to diarrhea is the highest.
Thus, we propose to develop an integrated, low-cost, point-of-care (POC) test to identify the GI
pathogens that cause diarrheal diseases. This test will be useful in resource-limited settings of
the developing world as well as in primary care settings of the developed world where it will be
useful to detect the GI pathogens in real time, in the clinician's office so the patient can be
treated with the right drugs, right away, without loss of patients to follow up. The major problem
with detecting gastrointestinal (GI) pathogens is the complexity of stool samples, often filled with
particulate and molecules such as bile salts. Such contaminants can inhibit signal amplification
and detection if not properly removed from the sample. In previous SBIR projects, GoDx has
developed sample preparation chemistry, DNA amplification and detection assays on lateral
flow paper strips for a suite of GI pathogens. Our next step is to develop a pathogen detection
device that fully integrates sample processing and signal amplification, which can be used
rapidly at the point of care (POC). To achieve this, we propose to develop a stool sample prep
device that can robustly provide viable DNA for amplification and detection all while requiring
minimal user action to do so. The technology proposed here will be able to extract and enrich
DNA from a swab of stool in a matter of minutes without the need for centrifuges or pumps. In
Phase 2 of this project, we will fully integrate the GoDx’s amplification and detection assays
with the sample prep technology developed here, providing a seamless, minimal step POC
device for the detection of GI pathogens that cause diarrheal diseases around the world.
