Key TakeawaysSepsis is a potentially fatal complication of infection.Sepsis can be difficult to identify early on. However, the sooner a patient is diagnosed, the better the prognosis.A new test may help identify patients at the highest risk of sepsis, allowing them to begin treatment sooner.A new test may be able to help emergency rooms identify patients with sepsis before the life-threatening condition becomes too hard to treat. Its developers say earlier diagnosis is essential for better outcomes, since sepsis is responsible for one in three hospital deaths.The blood test, calledIntelliSep, received clearancefrom 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.”What Is Sepsis?Sepsisis an exaggerated, whole-body response to an infection that affects nearly 1.7 million adults in the U.S. each year.Any infection can lead to this complication, but two of the most common predisposing conditions are pneumonia and urinary tract infections (UTIs). Bacteria cause most cases of sepsis, but so can viruses, fungi, and parasites.How the Test WorksWhen 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 toclinical 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 SepsisWhile 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 theUniversity of Maryland Medical Center, told Verywell.Symptoms of SepsisHigh or low temperatureMental status changes, such as confusion or excessive drowsinessShortness of breathSevere painDangerously low blood pressureThere 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 TestThe 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.What This Means For YouThe IntelliSep test is not yet widely available in hospitals. In the meantime, the best way to prevent sepsis is to prevent infection with regular handwashing and limited contact with infectious individuals.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.Correction - January 27, 2023: This article was updated to correct a misspelling of the name of Ajay Shah, PhD.

Key TakeawaysSepsis is a potentially fatal complication of infection.Sepsis can be difficult to identify early on. However, the sooner a patient is diagnosed, the better the prognosis.A new test may help identify patients at the highest risk of sepsis, allowing them to begin treatment sooner.

Key Takeaways

Sepsis is a potentially fatal complication of infection.Sepsis can be difficult to identify early on. However, the sooner a patient is diagnosed, the better the prognosis.A new test may help identify patients at the highest risk of sepsis, allowing them to begin treatment sooner.

A new test may be able to help emergency rooms identify patients with sepsis before the life-threatening condition becomes too hard to treat. Its developers say earlier diagnosis is essential for better outcomes, since sepsis is responsible for one in three hospital deaths.

The blood test, calledIntelliSep, received clearancefrom 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.”

What Is Sepsis?Sepsisis an exaggerated, whole-body response to an infection that affects nearly 1.7 million adults in the U.S. each year.Any infection can lead to this complication, but two of the most common predisposing conditions are pneumonia and urinary tract infections (UTIs). Bacteria cause most cases of sepsis, but so can viruses, fungi, and parasites.

What Is Sepsis?

Sepsisis an exaggerated, whole-body response to an infection that affects nearly 1.7 million adults in the U.S. each year.Any infection can lead to this complication, but two of the most common predisposing conditions are pneumonia and urinary tract infections (UTIs). Bacteria cause most cases of sepsis, but so can viruses, fungi, and parasites.

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 toclinical 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 theUniversity of Maryland Medical Center, told Verywell.

Symptoms of SepsisHigh or low temperatureMental status changes, such as confusion or excessive drowsinessShortness of breathSevere painDangerously low blood pressure

Symptoms of Sepsis

High or low temperatureMental status changes, such as confusion or excessive drowsinessShortness of breathSevere painDangerously low blood pressure

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.

What This Means For YouThe IntelliSep test is not yet widely available in hospitals. In the meantime, the best way to prevent sepsis is to prevent infection with regular handwashing and limited contact with infectious individuals.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.

What This Means For You

The IntelliSep test is not yet widely available in hospitals. In the meantime, the best way to prevent sepsis is to prevent infection with regular handwashing and limited contact with infectious individuals.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.

The IntelliSep test is not yet widely available in hospitals. In the meantime, the best way to prevent sepsis is to prevent infection with regular handwashing and limited contact with infectious individuals.

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.

Correction - January 27, 2023: This article was updated to correct a misspelling of the name of Ajay Shah, PhD.

2 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Centers for Disease Control and Prevention.What is sepsis?National Library of Medicine: MedlinePlus.Sepsis.

2 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Centers for Disease Control and Prevention.What is sepsis?National Library of Medicine: MedlinePlus.Sepsis.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Centers for Disease Control and Prevention.What is sepsis?National Library of Medicine: MedlinePlus.Sepsis.

Centers for Disease Control and Prevention.What is sepsis?

National Library of Medicine: MedlinePlus.Sepsis.

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