Novel ultrasensitive detection device for early Sepsis diagnosis

EU project IVD4Sepsis developed a test to spot an often little-discussed killer, sepsis, in its early stages when it’s easier to treat.

The IVD4Sepsis project devised a test to improve the diagnosis of one of the world’s greatest killers, sepsis. According to the World Health Organization, 6 million people die from the disease every year worldwide, yet many of these deaths are preventable.

Some 30 million people a year contract sepsis, an organ dysfunction, triggered by an uncontrolled response of the immune system, which can lead to organ failure and death. That is more than the numbers contracting AIDS, prostate cancer and breast cancer put together, calculates project coordinator Dr Óscar Ahumada. But many patients and doctors fail to recognise the illness’s symptoms.

Dr Ahumada hopes the new test will play a vital role in reducing the rate of global deaths. Since the molecule-counting digital technology takes just a few minutes to return results after a blood test, it can help diagnosis within the first hour of sepsis presenting in a patient when there is an 80 % survival rate. After the sixth hour, the patient has just a 30 % chance.

“Our test is about 1 million times more sensitive in terms of concentration detection than conventional technologies and much faster at giving the results,” says Dr Ahumada, general manager of Spanish company Mecwins.

“It’s crucially important the early symptoms of sepsis are recognised by both the public and the healthcare sector, so that treatment is accessed, where possible, within the first hour – the ‘Golden Hour’,” Dr Ahumada adds.

Current diagnosis is based on the identification of pathogens in the bloodstream, but the method lacks sensitivity and takes time to deliver the results, and positive blood cultures are found in less than a third of patients.

Part of the problem is that sepsis is a clinical syndrome difficult to define and, therefore, difficult to diagnose. Health experts have proposed many definitions of the illness over the last 10 years, concluding it is an overwhelming immune response to infection but many types of microbes can cause it. Bacteria is the most common cause, but fungi and viruses are also causes.

Global problem

Severe cases may result from a body-wide infection that spreads through the bloodstream. Invasive medical procedures like surgery or inserting a tube into a vein can introduce bacteria into the bloodstream and bring on the condition. Sepsis can also come from an infection confined to one part of the body. Children and pregnant mothers suffer from it in low-income countries, but so do 1.7 million adults in the wealthy United States.

The symptoms are often missed, until it is too late. The researchers on IVD4Sepsis managed to use a prototype technology developed in 2016 by Mecwins to detect the sepsis biomarkers that can identify the disease. “These biomarkers have endogenous levels lower than 1 pg/mL, undetectable with standard technologies used in clinical routines,” said Dr Ahumada.

They believe their technology could be applied to diagnose other diseases where protein biomarkers have been defined but are present in low concentrations. Mecwins is now working with Spanish pharmaceutical group Grifols and its unit Progenika Biopharma, which has taken a 25 % stake in Mecwins, to commercialise the technology.

“We believe this disruptive technology can very quickly substitute today’s technologies,” said Dr Ahumada.

Keywords
IVD4Sepsis, sepsis, biomarkers, molecule-counting digital technology, immune system

Reference source: Novel ultrasensitive detection device for early Sepsis diagnosis