POC Sepsis Diagnostic Platform to Speed up Clinical and Treatment Decision Making

Early presentation and diagnosis is vital and can increase the chances of survival significantly. However, serious limitations in the current methods for detecting the causative pathogens in sepsis present a major obstacle to increasing the speed of diagnosis and thus improving patient outcomes in a condition that is time critical. Now, a bedside instrument for the rapid diagnosis of sepsis could deliver results within a two-hour time window to help the clinical team plan proper management.

Great North Research & Innovation (GNRI, Newcastle Upon Tyne, UK) is building a patient focused tool to assist clinicians in determining the causative pathogens in sepsis rapidly and accurately. GNRI's work aims to improve patient outcomes, to enable optimal treatment pathways and to reduce healthcare costs.

Globally, it is estimated that there are 28.5 million patients and 11 million deaths from sepsis each year, and the numbers are increasing at an average rate of 10% annually. Sepsis occurs when an infectious organism is present in large numbers in the blood stream, overwhelming the body's immune system and leading to a generalized whole-body inflammatory response and shutting down of the vital organs. When a clinician suspects sepsis, several blood tests are carried out in order to reach a definitive diagnosis. The gold standard test for identifying the causative organisms in Sepsis is currently blood cultures, which require a minimum of 48 hours and up to five days to provide results. Until the results are obtained, patients only receive supportive treatment in the form of oxygen, fluids and broad-spectrum antibiotics. A large proportion do not survive this delay and in many cases, patients become critically ill and die before the results of the tests become available to clinicians.

In addition to the increased possibility of mortality and co-morbidities, delays to conclusive diagnosis in cases of sepsis lead to significantly increased costs for healthcare providers. Extended periods of emergency treatment for serious complications arising from infections contribute to an enormous cost burden on the healthcare system. The costs for ongoing care and treatment for recovered patients experiencing troublesome sequalae as a result of sepsis are considerable. Furthermore, the current practices of prescribing broad spectrum antibiotics cause an imbalance in the bacterial population of the body in already weakened patients, and contribute to the proliferation of antibiotic resistance. Thus, the need for an effective solution for the rapid diagnosis of sepsis has never been greater.

The easy to use rapid and sensitive GNRI diagnostic system could identify bacteria or fungi in a blood sample within a two-hour time frame at the patient’s bedside. Using a venous blood sample in a standard vacutainer, the system will handle all aspects of the process: from sample preparation to incubation, to reading and interpretation of results. The initial target is sepsis, but the utility of the system lends itself to multiple applications in other areas of healthcare. GNRI expects to develop a prototype of the device by the end of the year that would be about the size of a laser printer. The GNRI diagnostic system will be ideal for clinics, emergency rooms or high dependency wards and can also be used by non-laboratory personnel.

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