Critical role of rapid diagnostics in sepsis identification and antimicrobial stewardship

Ran in CAP Today, 24 June 2026

By Dr. Lindy Carlstrom, Medical Affairs Manager, QuidelOrtho

The following is an extended release prepared by QuidelOrtho.

Each year, at least 1.7 million adults in the U.S. are diagnosed with sepsis, a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs.¹ On average, 350,000 patients will die from sepsis per year, making it the leading cause of death in U.S. hospitals in 2024. Most commonly, sepsis starts with an infection in the gastrointestinal tract, lungs, skin, or urinary tract that the body’s immune system attempts to fight off.^1,2

Sepsis requires rapid diagnosis and treatment to prevent organ failure of the lungs, kidneys, and liver and even death.³ But health care providers face the challenge of balancing the urgency of initiating treatment for sepsis while mitigating antimicrobial resistance by selecting the appropriate antimicrobial for the infection.⁴ Rapid diagnostics and real-time monitoring systems play a critical role in providing life-saving care for sepsis patients and reducing antimicrobial resistance by improving antimicrobial stewardship.⁹

While anyone can acquire sepsis, highrisk groups such as the elderly (over 65 years), immunocompromised, and those with chronic illnesses such as heart disease, chronic obstructive pulmonary disease, diabetes, and cancer have an increased risk for both community- and hospital-acquired sepsis.⁵

The difference between community-acquired and hospital-acquired sepsis lies in where the infectious agent was contracted. Hospital-acquired sepsis is defined as sepsis that develops from an infection occurring at least two days after hospital admission.⁶ Each year, between 10 percent and 15 percent of adult sepsis cases occur in the hospital.⁷ When it comes to community-acquired sepsis, the leading causes are pneumonia, urinary tract infection, skin and soft tissue infection, and gastrointestinal infections. Pregnant women and infants are also at high risk of developing sepsis. Regardless of how a patient acquires sepsis, accurate and timely treatment is critical to save lives, and rapid diagnostics enable a faster time to care.⁹

It’s estimated that around 50 percent of cases are not correctly identified as sepsis, given there is no single test with high specificity for sepsis.⁸ Bacterial infections are the most common cause, but viral infections such as influenza and COVID-19 and even fungal infections can also progress to sepsis.⁹ Common symptoms can include clammy or sweaty skin, confusion or disorientation, lightheadedness, low blood pressure, extreme pain or discomfort, fever, high heart rate, and shortness of breath. However, many of these symptoms, such as fever and low blood pressure, are also common in other conditions, making sepsis difficult to diagnose without a complete clinical picture.¹

Due to the potentially rapidly progressive nature of sepsis, every minute wasted in not treating the infection puts a patient at a greater risk of death.⁹ The Centers for Medicare and Medicaid Services requires initiation of intravenous broad-spectrum antibiotics within three hours of recognizing severe sepsis or septic shock.¹⁰ This tactic, while it can help treat patients, does not affect viral or fungal infections and has led to the widespread use of antibiotics in critically ill patients when antibiotics may not be necessary.^1,8

The best balance of rapid sepsis treatment with antimicrobial stewardship is de-escalation from broad-spectrum to narrow-spectrum antibiotics as soon as laboratory results are available.⁸ Procalcitonin can help guide antibiotic stewardship and shorten the duration of therapy.¹³ Taking a proactive approach to using procalcitonin to support appropriate antimicrobial use and timely de-escalation is vital to improving patient outcomes. Procalcitonin-guided antibiotic stewardship protects individual patients from the adverse effects of excess antibiotics and protects society in general from potential sources of antimicrobial resistance.¹³

Antimicrobial stewardship programs are highly effective in the fight against antimicrobial resistance. Clinical settings that are less equipped with the latest technologies in rapid diagnostics face more challenges implementing these programs.⁸ Lack of funding and staffing shortages in some hospitals can also be barriers to the successful implementation of antimicrobial stewardship programs. Still, it’s imperative that hospitals adhere to local guidelines on antimicrobial usage and that all staff remain educated on the risks of antimicrobial resistance to ensure antimicrobials continue to remain effective.⁸

Early, rapid identification of sepsis using clinical criteria in a scoring system, which focuses on vital signs such as SIRS (systemic inflammatory response), NEWS (national early warning score), or MEWS (modified early warning score for clinical deterioration), is recommended in the 2021 Surviving Sepsis Campaign.¹² Since a third or more of patients initially diagnosed with sepsis ultimately do not have an infection, continuous assessment for the most likely diagnosis is best, especially as a patient’s clinical trajectory evolves after hospital admission.¹² Doctors rely on multiple information sources to delineate between infectious and noninfectious causes of acute illness. The sooner sepsis is detected, the faster patients can be clinically managed, which decreases time to treatment and therefore improves mortality.

Each hour of delay in the correct antimicrobial administration increases a sepsis patient’s mortality by 7.6 percent.¹¹ Fully integrating antimicrobial stewardship strategies into clinical practice is one of the most effective ways to uphold optimal empirical antibiotic therapy while minimizing antibiotic use. These strategies include quality improvement and the use of rapid diagnostic tests with adequate biomarkers.⁸ By combining timely diagnostics with informed clinical decision-making, health care teams can significantly improve patient outcomes in sepsis care. For more information regarding the diagnosis and treatment of sepsis, refer to The International Guidelines for Management of Sepsis and Septic Shock 2021.¹²