The blood test, called IntelliSep, received clearance from the FDA in January. It will be available for use in the ER in the coming weeks.
“As many as 80% of sepsis deaths could be prevented with rapid detection and treatment,” Ajay Shah, PhD, cofounder and CEO of Cytovale, who manufactures IntelliSep, told Verywell. “Early diagnosis is essential because that’s when clinicians can make the biggest impact.”
How the Test Works
When the immune system detects an infection, white blood cells should only respond to area of the body that is infected. But in the case of sepsis, the immune system’s reaction occurs across the entire body and runs amok.
IntelliSep is able to measure unique changes to the white blood cells that occur with sepsis, which no other test on the market can do. These structural changes can alert providers that a patient may develop sepsis as a result of their infection.
Within 10 minutes, the test can identify whether a patient has a high, medium, or low probability of developing sepsis, according to clinical trial results.
To conduct the trial, researchers recruited 572 adults who were admitted to the emergency room with signs of infection. Among participants aged 65 and older, the test proved 67.7% accurate at its high-risk predictions, but only 39.4% accurate among those under 65.
There Is No Diagnostic Test for Sepsis
While the accuracy level of IntelliSep is far from perfect, any tools are helpful to improve the sepsis diagnosis process, which can be quite difficult due to the ambiguity of the condition. Currently, clinicians make a diagnosis of sepsis when a patient presents with an infection, along with other signs and symptoms described below.
“Sepsis has many signs and symptoms that are non-specific. Many conditions, including non-infectious syndromes, can present with a sepsis-like picture,” Jonathan Baghdadi, MD, PhD, an infectious disease physician and hospital epidemiologist at the University of Maryland Medical Center, told Verywell.
There is currently no test that will definitively diagnose sepsis. If a provider suspects sepsis, they may order tests like blood cultures, sputum cultures, or urine cultures to rule out other infections, like infections in the blood, respiratory system, or bladder. But IntelliSep would be the first tool of its kind to actually screen for biomarkers of sepsis itself.
How Providers Can—and Can’t—Use the Test
The structural changes to the white blood cells that IntelliSep detects can also be seen with other inflammatory conditions, so IntelliSep alone can not diagnose sepsis. However, knowing that a patient is at a higher risk of developing sepsis can put providers on alert to be on the lookout for sepsis complications and act sooner.
Healthcare providers can use the IntelliSep results to guide further management of a patient’s care. A medium-risk result might prompt a clinician to order further tests to determine the cause of a patient’s illness. A high-risk result should encourage providers to be on higher alert to assess for signs of impending sepsis.
ER teams could use this data to help prioritize care for patients, such as starting antibiotics sooner.
“Patients are known to benefit from broad-spectrum antibiotic therapy started as soon as possible, particularly when septic shock is present,” Baghdadi said. “In some cases, this means that a patient will be started on antibiotics first and then ruled out for infection later.”
However, Baghdadi cautions that because the test is not perfect, providers run the risk of administering unnecessary antibiotics if they start a course of treatment based on its results.
The IntelliSep team thinks the test will also help healthcare providers outside of the ER down the road.
“The current FDA clearance is only for use in the ER, but we are continually looking to expand our trial to other uses in the hospital,” Shah said.
Ultimately, recognizing sepsis earlier will save patients money. Severe sepsis often requires treatment in the intensive care unit and can lengthen a patient’s length of stay, significantly elevating the cost of care.
Correction - January 27, 2023: This article was updated to correct a misspelling of the name of Ajay Shah, PhD.
If you do suspect an infection, do not delay seeking treatment. If you or a loved one develop signs of sepsis, seek immediate medical care since prompt treatment could mean the difference between life and death.
