A life-saving blood test that can detect sepsis in less than 10 minutes by drawing white blood cells could be available in 11 U.S. states by the end of the year.
You may not hear many news headlines about sepsis, but researchers in the United States have hailed the development as one of the most important breakthroughs in modern medical history and a “turning point” in the fight against one of the world’s deadliest diseases.
The test involves drawing a small amount of blood into a small tube to see if white cells that act on the immune system change shape.
The white blood cells of a patient with sepsis are softer and more squishy than those of a healthy person, and they flatten and elongate when pressed. The longer the cells are, the more likely a patient is to develop sepsis.
Measuring cell shape to detect sepsis is not new, but previously the process took up to two days and produced mixed results.
Until now, scientists had to use a microscope to manually examine and count the number of mutated white blood cells, a laborious process that often resulted in misdiagnosis or misdiagnosis.
“Sepsis is notorious as a ‘silent killer’ because its symptoms can often be mistaken for other, less serious illnesses, so it is easily overlooked in the early stages,” says Professor Michael Attar, a British scientist and lecturer at New York University who has been nicknamed “Mr Sepsis” in medical circles.
“Rapid diagnosis and treatment are critical to achieving good outcomes, but the lack of a single, reliable diagnostic test for doctors to use has cost precious time and lives.
However, IntelliSep inspection detects even subtle deformations using high-speed cameras that can capture more than 500,000 frames per second.
The images are then analyzed by a state-of-the-art AI-based computer, which counts the mutated white blood cells in minutes and provides a digital readout with an average accuracy of 97%.
IntelliSep’s parent company, Silicon Valley firm Cytovale, where Professor Atar has been a major investor and consultant for the past decade, described the trial as “truly groundbreaking” and said it has the potential to save millions of lives each year.
Unlike other breakthroughs that have not progressed beyond medical trials, IntelliSep has already received FDA approval for use in the United States.
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The system is currently in use at one hospital in Louisiana and is expected to be rolled out to 10 other U.S. hospitals by the end of 2024.
“By any objective measure, Cytovale’s IntelliSep device is the ‘holy grail’ that the medical community has been desperately seeking,” Atar told reporters from his home in London. “The technology behind this device is truly groundbreaking and has real, proven potential to save millions of lives worldwide each year.”
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Sepsis, or blood poisoning, kills one person every three seconds, or 11 million people a year. That’s more than breast, prostate, and colon cancers combined. Sepsis is usually caused by an abnormal immune response to a bacterial infection in a wound, either internal or external, causing an inflammatory response that makes the situation worse and doesn’t get better.
White blood cells that normally protect the body from harmful bacteria overreact and start destroying healthy cells instead. If not diagnosed and treated promptly, it can lead to organ failure and death within 12 hours of antibiotic treatment.
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To date, there has been no rapid, reliable diagnostic test that has undergone successful medical trials and received regulatory approval.
Instead, doctors had to rely on the presence of secondary symptoms, such as high blood pressure and heart rate, to make a mathematical guess about whether an infected patient was at risk for developing or suffering from sepsis.
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