Children are the most vulnerable during their first few days of life. Within the first 72 hours of birth, bacterial pathogens can cause severe bloodstream infections, known as early onset neonatal sepsis (EONS). EONS results in up to 42% of neonatal deaths within the first week of life in low- and middle-income countries. In Kenya, neonatal sepsis is most commonly caused by E. coli, S. agalactiae (Group B Streptococcus, GBS), or K. pneumonia. Currently, blood cultures are required for diagnosis and involve 24-48 hour incubation periods before sepsis can be confirmed. However, most births in low- and middle-income countries are out-of-hospital, and even district level hospitals may lack both infrastructure and training to perform blood cultures. Further, every hour without treatment of sepsis raises the risk of death by nearly 8%. Without a positive such culture, neonatal sepsis either remains undetected resulting in high infant mortality, or, if a medical team is present, will be presumptively treated with broad-spectrum antibiotics and referral to higher level facilities for blood culture. This rush to refer suspected EONS cases is cost-prohibitive for both healthcare services and families of at-risk infants. Rapid, the point-of-care (POC) detection and identification of the pathogens underlying neonatal sepsis would allow these neonates to be managed at lower-level clinics and even in the community. These tests will require rapid, portable, and highly sensitive pathogen identification with simple operation and clear interpretation. 

We are developing DxEONS, a low-cost nucleic acid diagnostic platform for POC detection of the most common neonatal sepsis pathogens, resulting in a simple Yes/No readout for each pathogen. By combining multiplexed lateral flow detection with mobile-phone powered isothermal nucleic acid amplification, we will enable the diagnosis of sepsis within hours of onset. 

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Provide a status update for your Innovation.

We are just getting started and brainstorming development and implentation strategies. Dr. Linnes has visited her co-Investigators at AMPATH in Kenya this June.

How does your innovation work?

With the support of AMPATH pediatricians and researchers in Kenya, led by Professor Fabian Esamai at Moi University, we have devised a mobile nucleic acid diagnostic for rapid neonatal sepsis detection that is as easy to use as a pregnancy test. This co-development model is integral to ensuring that the correct pathogen targets and resource constraints (e.g. time, low-cost, power, training, etc.) are fully addressed so that the project has the greatest impact on community healthcare at clinics and households at the point-of-care. The DxEONS device will allow limited resources such as antibiotics, intensive care facilities, and personnel to be dedicated to the highest risk infants in order to improve neonatal mortality and health economics of neonatal sepsis management in community healthcare settings throughout Kenya.

Do you have current users or testers?

This device is currently being developed and tested in laboratory settings. Future research will implement community based use and testing compared to blood culture gold standards.

What is your strategy for expanding use of your innovation?

We are working with entrepreneurs and incubators both at Purdue University and AMPATH for future scale-up.