A Rapid and Highly Sensitive, Point-of-Care, Simple Paper-Based Neonatal Sepsis Test

Godx, Inc., Madison WI

Investigators

Abstract

Project Summary/Abstract. Worldwide more than a million newborn babies die each year, mostly in the developing world, due to serious bacterial infections, typically sepsis or commonly known as ?blood poisoning.? The diagnosis of neonatal sepsis remains challenging since many infants show subtle and non- specific clinical signs. Due to the fear of missing a positive diagnosis, the established clinical practice in US and many developed countries is to conduct ?rule-out? tests, which are imprecise, invasive, requiring large blood sample draws and are costly. Most of all, these tests prove unnecessary for the vast majority of infants (99%) who do not have sepsis, rather may present with other neonatal disease processes that mimic sepsis. A related and widespread practice for the same ?rule-out? reasons is the accompanying prescription of antibiotics, which in the short or long run can harm the baby or render it resistant. Importantly, current diagnostic lab tests can take more than 2 days and have a high percentage of either false positives or negatives due to poor sensitivity and specificity. GoDx proposes to develop in this Phase I SBIR project a novel, low-cost, paper-based, and highly-sensitive point of care diagnostic test that promises to significantly advance and improve the standard treatment paradigm for neonatal sepsis. To prove the feasibility of developing such a test, we will aim to establish important performance benchmarks and demonstrate superior blood sepsis biomarker detection. We will focus on the evaluation of a proprietary combination of biomarkers, which have shown promising results in our preliminary work. The resulting manufacturing process of our diagnostic tool will be uniquely simple and low-cost so that it is ideal for use in the developing world where inadequate infrastructure prohibits the use of more complex lab test dependent on electricity and expensive specialized instrumentation. When successfully completed, we hypothesize that our test will be able to detect sepsis specific biomarkers with 95% specificity and 99% sensitivity within less than 30 minutes. Development of the multiplexed paper strip test in this project, will position GoDx for prototyping and optimization of the prototype in Phase II. !