A life-saving blood test that can detect sepsis in under ten minutes by squeezing white blood cells could be available in as many as 11 US states by the end of the year.
While you won’t hear many news headlines about sepsis, US researchers 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 works by forcing a small amount of blood through a tiny tube to see if the white, immune-fighting cells change shape.
White cells in sepsis-affected patients are softer and more squishy than those in healthy people and become flattened and elongated under pressure. The more elongated the cells a patient has, the more likely they are to have sepsis.
Measuring cell shape to spot sepsis isn’t new, but the process has previously taken up to two days and yielded mixed results.
Until now, scientists have had to scrutinize and count the number of deformed white cells themselves using a microscope—a laborious process that has led to numerous wrongful or missed diagnoses.
“Sepsis is notorious as the ‘silent killer’ because it is so easily missed early on, when a patient’s symptoms can often be mistaken for other less serious illnesses,” said Professor Michael Atar, a British-based scientist and lecturer at New York University, dubbed “Mr. Sepsis” by the medical community.
“Rapid diagnosis and treatment is crucial to a good outcome, but there has never been a single, reliable diagnostic test available to doctors, costing precious time and people’s lives.
However, the IntelliSep test detects microscopic deformities using an ultra-high-speed camera that can capture over 500,000 frames per second.
The images are then analyzed by a state-of-the-art, AI-powered computer that tallies up the misshapen white cells in a matter of minutes and provides a digital reading with an average accuracy rate of 97%.
Cytovale, the Silicon Valley firm behind IntelliSep, for whom Professor Atar has been a lead investor and consultant for the past decade, describes the test as “genuinely groundbreaking” with the potential to save millions of lives each year.
Unlike other claimed breakthroughs that have never progressed beyond medical trials, IntelliSep has already been approved for use in the US by the FDA.
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It is currently in use at a hospital in Louisiana and will be rolled out to 10 other US hospitals by the end of 2024.
“Cytovale’s IntelliSep device is, by any objective measure, the ‘holy grail’ that the medical community has been so desperate to find,” Atar told reporters from his London home. “The technology behind it is genuinely groundbreaking and it has the real-world, tried-and-tested potential to save millions of lives, year on year, across the planet.”
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Sepsis, or blood poisoning, kills one person every three seconds, and 11 million annually— more than breast, prostate, and bowel cancer combined. It is most commonly caused by an abnormal immune reaction to a bacterial infection from a wound, either internally or externally, which leads to an inflammatory response that makes things worse, not better.
White blood cells that normally work to protect the body from harmful bacteria overreact and start destroying healthy cells instead. If it is not diagnosed and treated immediately, usually with antibiotics, it can lead to organ failure death in as little as 12 hours.
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Until now, there has been no rapid and reliable diagnostic test that has undergone successful medical trials and received regulatory approval.
Doctors have instead been forced to rely on the presence of secondary symptoms, like high blood pressure and heart rate, to make a calculated guess if a patient with an infection could be at risk of or is suffering from sepsis.
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