ARTICLE SUMMARY:
A diagnostic start-up gives clinicians an objective predictor of a common, costly, and deadly complication.
One in five people who visit a hospital’s emergency department (about 30 million patients per year in the US) has signs of possible infection upon arriving at triage. These signs may include elevations in heart rate, respiratory rate, blood pressure, and body temperature, which are broad symptoms with many conceivable causes. Any of these patients could be at risk of developing sepsis, which is not an infection itself, but the body’s dysregulated immune response to infection that can affect the internal organs and result in fatal outcomes. Sepsis is the single most costly inpatient expense for US hospitals, and those with more than 500 beds may spend more than $34 million a year on sepsis-related costs.
Up to 21% of those who experience sepsis have a delayed diagnosis or misdiagnosis, the consequences of which are dire as the septic shock mortality rate increases 8% for every hour of treatment delay once it sets in. As many as one-third of all hospital deaths in the US can be attributed to sepsis. Although sepsis does not have a single hallmark clinical sign, and no definitive test exists to diagnose it, blood cultures and lab tests measuring lactate and procalcitonin have a combined negative predictive value (NPV) of anywhere between 78% and 93%.
Current gold-standard microbiological blood tests take days to return a result and are imprecise at indicating sepsis as more than half of patients who are clinically septic never have a positive blood culture. This could occur either because bacteria simply did not grow in the sample or because the underlying infection may be localized (as in cases of pneumonia or an abscess) and doesn’t enter the bloodstream. To help providers risk-stratify potentially septic patients with greater confidence, Cytovale has developed IntelliSep, a diagnostic that focuses on the immune response itself, not the pathogen that originally caused it.
