TB or Not TB: An Innovative Gastric Collection Device for Improving Pediatric Tuberculosis Diagnosis

Team members: Jordan Addison, Amelia Adelsperger, Amy Koester, Daniel Romano, Julia Swartzenberg

Tuberculosis, a bacterial infection, primarily attacks the lungs, leading to intense fatigue and weight loss, a sputum-producing cough, and death. Of the 450,000 new cases of tuberculosis (TB) diagnosed in South Africa each year, approximately 15-20% occur in children. This pediatric subpopulation goes largely undiagnosed due to their inability to cough up a bacterial sample for conventional diagnosis. Currently, the two best techniques for obtaining this sample are sputum induction and gastric lavage, which are highly invasive, uncomfortable, and require clinical settings. A rapid diagnostic device, GeneXpertTM, is readily available in South Africa, but is useless for diagnosing pediatric TB without a bacterial sample. Because of the difficulties associated with obtaining these samples from children, there is a need for an inexpensive, intuitive, and non-invasive method of collecting GeneXpertTM-compatible bacterial genome samples. Therefore, our team has designed a solution that utilizes the body’s natural processes to collect a bacterial sample, eliminating the need for distressing procedures that require administration by trained clinicians. Our proposed solution involves a smart pill device that, once activated by the acidic stomach juices, collects a bacteria-containing gastric aspirate sample before sealing itself off and continuing through the GI tract for collection upon excretion. Once it has been collected, the gastric acid sample may be used with the GeneXpertTM machine for diagnosis. Bench testing has demonstrated that this device is able to collect an equivalent sample to gastric lavage per administration (5 mL), before stomach emptying occurs (6 minutes), and is applicable in South African children due to its FDA-approved size (11x26 mm), the incorporated delivery lubricant, and its low cost (8.00 USD per pill). We expect the implementation of this device to revolutionize TB diagnosis in the South African pediatric population due to its simplistic and naturally intuitive design.

Видео TB or Not TB: An Innovative Gastric Collection Device for Improving Pediatric Tuberculosis Diagnosis канала Weldon School of Biomedical Engineering, Purdue University