Study Supports World’s Fastest Sepsis Test

Nanotechnology-based diagnostics experts Abionic SA, has announced initial positive results from evaluation studies with its rapid PSP test for sepsis risk assessment and management.

Background

Sepsis is the most common cause of mortality in intensive care units. It is a syndrome characterized by an overwhelming systemic response to infection, which can rapidly lead to vital organ dysfunction, and death. Sepsis accounts for 40% of total ICU expenditure and every year, 18 million individuals worldwide die from sepsis.

Early diagnosis and management of sepsis greatly improves chances of survival and mitigates the risk of suffering from severe, long-term, complications. Indeed it is the number one preventable death, if treated within the first hour.

Abionic’s CE marked, abioSCOPE® is the only device worldwide that provides results showing an indication of sepsis within 5 minutes.

The device measures Pancreatic stone protein (PSP), described as a biomarker in the early detection of sepsis. The instrument comprises a fully automated fluorescent microscope, a mounting plate (the abioDISC), onto which is placed a single-use disposable IVD CAPSULE. Following preparation, the sample is placed into the IVD CAPSULE and the abioDISC is inserted into the abioSCOPE, in the same way that a DVD is inserted into a player. In a few minutes the results are then presented on a high-resolution touch screen and saved onto a SD card provided by Abionic. The abioSCOPE can be used by any healthcare professional and does not require extensive training.

Now a study has been conducted at two internationally renowned university hospitals, Zurich University Hospital (Switzerland) and University College London Hospital (UK).

In the Zurich University Hospital study, measurement of PSP with the abioSCOPE was conducted daily for up to 8 days in a panel of ICU patients, with results blinded to the treating clinicians. Retrospectively, PSP values and medical records of the patient were compared. The data obtained suggested that a raise in the PSP value was observed in up to 24 hours before the apparition of clinical symptoms of sepsis. Moreover, a rapid return of the PSP value to baseline was also observed during the course of the antibiotherapy. The abioSCOPE PSP test could therefore be used by doctors to initiate antibiotic treatment earlier as well as to monitor for effectiveness of therapy.

University College London Hospital (UCLH) hosts one of the largest critical care unit in the UK (44 beds, 3000 patients per year). The evaluation of the PSP test in this unit is currently ongoing. To date, 15 patients within a week have been evaluated, with results confirming that the abioSCOPE is a well-designed, point of care (POC) diagnostic platform for use in ICU, typically next to a blood gas analyser.

Abionic is currently preparing an international clinical study in over 200 ICU patients to evaluate the efficacy of the abioSCOPE PSP test to help clinicians in identifying and managing patients at risk of sepsis and septic shock. Long-term, Abionic believes this test could be used in emergency departments for triage risk stratification, monitoring, discharge and antibiotic decision-making.

Investigator comments

“Pancreatic stone protein (PSP) is currently one of the most promising biomarkers to identify sepsis patients early. A precise and accurate sepsis biomarker makes sense only if it is readily available to the clinicians, and as seen from the data generated in our recently completed study, the 5 minute abioSCOPE platform is unique to provide this service,” said Professor Dr Rolf Graf, Head of Research, Department of Surgery and Transplantation, Zurich University Hospital.

“This POC test has the potential to help us identify sepsis patients more quickly than with currently available technologies. Introducing such a test complies with recently released NICE objectives as well as the guidelines issued earlier this year by the World Health Organisation (WHO),” said Dr Niall MacCallum, Leader of the Critical Care Clinical Trial Team at UCLH.

Company comments

“Accurately diagnosing sepsis early is crucial so that appropriate treatment can be started. This provides the greatest chance of success and patient recovery. These initial clinical evaluation studies have demonstrated the potentially huge impact our five minute test can have in hospital ICUs and emergency departments,” stated Dr. Fabien Rebeaud, Chief Scientific Officer of Abionic.

Source: Business Wire

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