Sepsis diagnosis and management

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Sepsis needs answers. Diagnostics need confidence.

Our commitment

Early detection and management of sepsis: Our mission

Sepsis is a life-threatening condition where early detection is critical. Because early signs are often vague and nonspecific, identifying which patients require admission remains a critical challenge.1 Optimizing testing resources and reducing costs is essential to ensure that patients who need hospitalization are safely admitted, while lifting the burden on caregivers and healthcare systems.2 

At Roche, we pioneer advanced diagnostics to empower the entire care team, including emergency and intensive care doctors, pulmonologists, stewardship teams, and lab physicians to deliver confident diagnostics and act decisively across the care continuum. By providing clear diagnostic insights when every minute counts, we also support effective antibiotic stewardship.

Supporting every decision across the continuum of care

Our comprehensive portfolio connects diagnostic technologies including, immunoassay, clinical chemistry, mass spectrometry, polymerase chain reaction (PCR), coagulation, Point of Care, and digital solutions, to deliver actionable insights at every stage of the patient journey:

  • Early recognition and triage: Differentiating severe bacterial infections from viral illnesses to clarify hospitalization needs and guide ICU placement.
  • Targeted therapy and optimized dosing: Identifying exact pathogens and conducting therapeutic drug monitoring (TDM) to ensure the right drug is delivered at the optimal dosage.
  • Response monitoring and de-escalation: Evaluating treatment efficacy through serial biomarker monitoring to enable safe antibiotic cessation to prevent over-exposure and resistance, and confirm recovery for safe discharge.

Through continuous collaboration with academia, healthcare providers, and industry partners, we are focused on ensuring that life-saving diagnostic solutions are accessible to those who need them most. Our goal is to create a future where early detection of sepsis leads to better patient outcomes and reduced healthcare burdens, improving the quality of care and saving as many lives as possible.

 

Disease burden

A leading cause of preventable deaths worldwide

Sepsis and septic shock have a multitude of causal factors. Septic shock is a severe complication of sepsis in which circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone.3 In 2017, sepsis impacted around 50 million people globally, claiming 11 million lives (20% of deaths globally).4

A critical threat to children and neonates

Children are especially vulnerable, with nearly half of all cases occurring in those under five, leading to 2.9 million deaths.4

The highest risk occurs during the first 28 days of life (the neonatal period). Each year, approximately 2.5 million neonates die within their first month, representing nearly half of all deaths in children under five. Sepsis is a leading cause of these newborn deaths, claiming an estimated 375,000 neonatal lives in 2018 alone (15% of all neonatal mortality).5

High stakes in the ICU: Every hour counts

Sepsis remains a major health problem in ICU patients and is associated with high mortality rates, exceeding 40% for septic shock. Every hour that appropriate therapy is delayed, mortality increases by 7.6%.6 This highlights the urgent need for timely and accurate diagnostics to support improved survival rates.3

Diagnostic challenges and impact overview

Advancing sepsis care

Sepsis is difficult to diagnose and often hard to distinguish from other conditions, due to the overlap of common symptoms, which can cause a delay in treatment.2,3 The lack of specific biomarkers for sepsis detection complicates early diagnosis and accurate triage in emergency and ICU settings. Sepsis can progress rapidly so time is critical. As every hour without treatment increases mortality by 8%.6 The absence of reliable biomarkers also hampers outcome prediction, severity assessment, and targeted therapy development. These diagnostic issues not only affect patient care and outcomes but also strain healthcare resources and public health efforts.

Through the development of complementary biomarkers, Roche’s solutions aim to address the greatest unmet needs in sepsis by delivering high-quality, cross-technology solutions that improve early detection, enhance triage decisions, and support better treatment options that can address critical gaps in sepsis management.

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Benefits of Roche diagnostic solutions for managing sepsis

Early and accurate diagnosis

Diagnostic tools for timely clinical decision-making

Patients with sepsis can deteriorate rapidly. Access to testing is key so that diagnosis and effective sepsis treatment can be initiated early.6 Roche provides a range of solutions across the septic patient continuum of care, to help physicians assess disease severity and support them in making these critical decisions, including:

  • Elecsys® IL-6 assay: Quantifies Interleukin-6 (IL-6) levels to aid in the management of critically ill patients as an early indicator of acute inflammation.7 Elevated IL-6 levels provide prognostic insights into the severity of inflammatory conditions, including sepsis, and can aid in diagnosis and  management of neonatal sepsis, post-operative infections, respiratory failure in COVID-19 patients.7

  • Elecsys® BRAHMS PCT assay: Quantifies procalcitonin (PCT) levels to support the early detection of bacterial infections, assess sepsis severity, guide antibiotic therapy, and monitor treatment outcomes.8

  • Tina-quant® C-reactive protein IV: Quantifies C-reactive protein (CRP) levels as a late marker of inflammation, infection, and sepsis.9

  • cobas® eplex BCID panels: Identify ~95% of clinically relevant bloodstream infections and their resistance genes, while rapidly ruling out blood culture contamination with the broadest coverage of any molecular test currently available in the market. *10-12

Antibiotic stewardship

Preventing antibiotic resistance, a major global threat

Improving antibiotic usage and dosing is a cornerstone of antibiotic stewardship, ensuring that lifesaving drugs remain effective when needed most, such as in critical sepsis care.

Diagnostic testing is essential for a successful antibiotic stewardship program. While traditional blood cultures remain standard practice for diagnosis and therapy decisions, they require a long time to deliver results and don’t always detect certain bacterial pathogens. 

Roche’s advanced diagnostic innovations empower clinicians with fast, actionable insights, enabling proper usage and optimized dosing across core technology portfolios including:

  • Immunoassay solutions:  Diagnostic solutions such as Elecsys® BRAHMS PCT (procalcitonin) help identify clinically relevant bacterial infections and monitor treatment response through serial measurements, supporting earlier, more targeted therapy and timely discontinuation of antibiotics when appropriate.8,13-16
  • Clinical chemistry solutions (cobas® ONLINE TDM assays): Measure drug concentrations in plasma and serum on routine analyzer platforms to enable accessible therapeutic drug monitoring (TDM) and guide patient-specific dose adjustments.
  • Mass spectrometry solutions (cobas® Mass Spec solution and Ionify® TDM assays for quantifying antimicrobials in plasma/serum): Timely availability of quantitative drug levels enables patient-specific dose optimization, supporting optimum treatment outcomes by preventing underdosing (reducing the risk of therapeutic failure and development of drug resistance) and overexposure (minimizing severe drug toxicity).17,18
Aiding the diagnosis of neonatal sepsis

Early diagnosis of sepsis may reduce mortality in newborns19

Sepsis affects more than 20 million newborns and children under 5.4 Neonatal sepsis can initially present with subtle signs, but can rapidly progress to multisystem organ failure.7 Signs and symptoms are often nonspecific and may overlap with those of other severe conditions, such as meningitis and pneumonia. Early detection and prompt intervention are essential to prevent severe and life-threatening complications.

  • Elecsys® IL-6 assay: Aids physicians in combating the impact of neonatal sepsis by facilitating an early diagnosis.7 Early and improved diagnosis can contribute to the appropriate use of antibiotics, as well as potentially decreasing mortality rates and mitigating the long-term consequences of sepsis.2

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White paper on AMR and sepsis: How diagnostics empower clinicians to tackle the coupled threat

Sepsis demands fast action, but antibiotic overuse fuels resistance that undermines treatment. Learn how Roche's diagnostic solutions empower clinicians to balance urgent care with stewardship for improved patient outcomes, now and in the future.

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*Detection rate based on panel inclusivity only, (not a sensitivity/performance claim) based on cobas® eplex BCID panels inclusivity compared to Roche internal database: 12 months of blood culture ID data from 40+ geographically diverse US hospitals (n=110,408).

References:

  1. Lafon T, et al. Challenges in early detection and prognostication of sepsis: new approaches from the emergency department and intensive care unit. EClinicalMedicine. 2026;94:103864.
  2. World Health Organization. Sepsis [Internet; cited 2026 Sep 14]. Available from: https://www.who.int/news-room/fact-sheets/detail/sepsis. 
  3. Singer M, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315:801–10. 
  4. Rudd KE, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: a systematic analysis for the Global Burden of Disease Study. Lancet. 2020;395:200–11.
  5. World Health Organization. Global report on the epidemiology and burden of sepsis: current evidence, gaps and future directions [Internet; cited 2026 Sep 14]. Available from: https://www.who.int/publications/i/item/9789240010789. 
  6. Kumar A, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34:1589–96. 
  7. F. Hoffmann-La Roche Ltd. Elecsys® IL-6. Method sheet. (v6.0). 2024. 
  8. F. Hoffmann-La Roche Ltd. Elecsys® BRAHMS PCT. Method sheet. (v2.0). 2023.
  9. F. Hoffmann-La Roche Ltd. cobas® CRP test. Method sheet. (v2.0). 2023.
  10. GenMark Diagnostics, Inc. cobas® eplex blood culture identification gram-positive (BCID-GP) panel. Method sheet. (v4.0). 2026. 
  11. GenMark Diagnostics, Inc. cobas® eplex blood culture identification gram-negative (BCID-GN) panel. Method sheet. (v5.0). 2026. 
  12. GenMark Diagnostics, Inc. cobas® eplex blood culture identification fungal panel (BCID-FP). Package insert. (v6.0). 2026. 
  13. Ventetuolo CE, Levy MM. Biomarkers: diagnosis and risk assessment in sepsis. Clin Chest Med. 2008;29:591–603. 
  14. Samsudin I, Vasikaran SD. Clinical utility and measurement of procalcitonin. Clin Biochem Rev. 2017;38:59–68.
  15. Schuetz P, et al. Effect of procalcitonin-guided antibiotic treatment on mortality in acute respiratory infections: a patient level meta-analysis. Lancet Infect Dis. 2018;18:95–107. 
  16. Rafiq S, et al. Clinical effectiveness of procalcitonin- or C-reactive protein-guided antibiotic discontinuation protocols for adult patients who are critically ill with sepsis: a rapid systematic review and meta-analysis. Anaesthesia. 2026;81:556–69.
  17. F. Hoffmann-La Roche Ltd. iAB1 Ionify®. Method sheet. (v1.0). 2025.
  18. F. Hoffmann-La Roche Ltd. iAB2 Ionify®. Method sheet. (v1.0). 2025.
  19. Al-Matary A, et al. Association between the timing of antibiotics administration and outcome of neonatal sepsis. J Infect Public Health. 2022;15:643–7.