Rapid Diagnostic Test Slashes Sepsis Mortality by 39%

Sepsis remains one of the most challenging and fatal conditions in contemporary healthcare, accounting for nearly one-third of all hospital-related deaths in the United States. In emergency departments (EDs), the absence of reliable and objective early risk assessment tools often leads clinicians to treat a broad range of patients as potentially septic. While this cautious approach is understandable in the high-pressure ED setting, it frequently results in unnecessary and non-beneficial treatments for individuals unlikely to have sepsis. In addition to being a clinical challenge, sepsis also poses a significant financial burden. Hospitals with more than 500 beds may face annual sepsis-related expenditures surpassing USD34 million. A major real-world study now shows that a sepsis diagnostic tool can lower the relative rate of sepsis mortality, reduce hospital stay duration, and improve resource utilization in the ED.

Cytovale’s (San Francisco, CA, USA) IntelliSep stands out as the first and only FDA-cleared diagnostic tool designed to support early detection of sepsis in emergency settings. It uses a standard blood sample and delivers results in approximately eight minutes. This rapid turnaround allows healthcare professionals to assess sepsis risk before traditional clinical symptoms become apparent, enhancing their ability to prioritize care for those in critical need. The integration of this fast diagnostic test with a structured workflow has resulted in what researchers have referred to as a “game-changing model” for healthcare systems across the country. The study tracked over 12,000 patients across a 12-month period at a 900-bed inpatient acute care hospital and Level 1 trauma center, where IntelliSep was used within a nurse-led sepsis triage program aimed at quickly identifying and managing patients at the highest risk.

Image: The U.S. FDA-cleared IntelliSep rapid host response diagnostic represents a breakthrough in sepsis care (Photo courtesy of Cytovale)

The findings, detailed in the journal Healthcare, reveal a 39% relative reduction in mortality among sepsis patients, while mortality among non-sepsis patients remained unchanged—highlighting IntelliSep’s role in improving targeted triage. Additionally, the average hospital stay for patients with sepsis was shortened by 0.76 days, signaling benefits for both patient flow and cost management. The research also noted a 40% drop in blood culture use for patients deemed low-risk and an 8% rise in usage among high-risk individuals. These patterns demonstrate IntelliSep’s capacity to enhance diagnostic accuracy and better align testing with patient risk levels.

"This is more than an innovation – it's a paradigm shift in how health systems are managing sepsis," said Dr. Hollis O'Neal, Medical Director of Research at OLOLRMC, the acute care facility which implemented IntelliSep. "For decades, sepsis mortality rates have remained stagnant because we've lacked a fast, reliable way to catch sepsis early. This study proves that with speed, objectivity and accuracy at the point of triage, we can change outcomes before antibiotics are given or ICU beds are needed. That's where real transformation begins."

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