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  5. Sepsis and the B·R·A·H·M·S Procalcitonin (PCT) Assay
Illustration of bacteria, for which procalcitonin is an early biomarker of infection related to sepsis

Advance the fight against sepsisExplore how the Atellica IM B·R·A·H·M·S Procalcitonin (PCT) Assay enables confident sepsis risk assessment and antibiotic management

Bar chart: Cause of death in the U.S. Sepsis is a medical emergency that can result from almost any infection. The bar chart shows heart disease as the top cause of death, with over 600,000, but sepsis is the second-highest bar, with around 250,000 deaths. Following sepsis are lung cancer (~150,000), and diabetes, colon cancer, breast cancer, pancreatic cancer, septicemia, and leukemia all come in at less than 100,000
Sepsis causes more deaths annually than lung, colon, and breast cancer combined. Sepsis survivors can experience life-long and life impacting deficits that include PTSD-type symptoms, amputations, and others.1,2​

Explore how PCT can be a useful marker for sepsis

Procalcitonin (PCT) is the prohormone of calcitonin that tissues and organs release in response to infection by most types of bacteria. The level of PCT in the blood rises as bacteria multiply and is typically and directly correlated with the severity of the infection.3 The Atellica IM B·R·A·H·M·S PCT Assay measures the level of procalcitonin in the blood.

Leading guidelines indicate PCT testing for sepsis risk assessment, and as a key tool for antibiotic stewardship by guiding antibiotic use and combating antibiotic resistance.4

PCT use in sepsis risk assessment helps to reduce long-term, infection-associated adverse events:5​

decrease in adverse events
decrease in antibiotics use
decrease in 28-day mortality
decrease in cost of hospitalization

Healthcare Impact

Advance the fight against sepsis

The PCT assay provides valuable information that can help guide clinical decisions, including risk assessment in the ICU for progression to severe sepsis or septic shock, aiding in decisions on starting antibiotics in specific cases and guiding decisions on antibiotic discontinuance. This ensures that interventions are both timely and precisely tailored to achieve the best possible patient outcomes.

Clinical Excellence
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Performance by Design

Clinical Excellence

The Atellica IM PCT Assay delivers B·R·A·H·M·S gold-standard performance with established algorithms and cut-offs. Through alignment to a validated gold standard, B·R·A·H·M·S PCT Assays demonstrate clinical excellence performance in multiple applications, giving physicians in your healthcare institution confidence when performing patient assessments.

“In our institution, we now consider measurements of procalcitonin to be a standard of care. It is now something that we could not live without.” * 
Dr. Erick Gluck
Director of Critical Care Services, Swedish Covenant Hospital

*
SelectScience webinar, (October 2024). The statements by the Siemens Healthineers customers described herein are based on results that were achieved in the customer's unique setting. Because there is no “typical” hospital or laboratory and many variables exist (e.g., hospital size, samples mix, case mix, level of IT and/or automation adoption) there can be no guarantee that other customers will achieve the same results.
Atellica® CI Analyzer
You can consolidate immunoassay and chemistry assays with the Atellica Portfolio.

Limit Less

In your healthcare system, PCT testing may be needed at many locations: reference labs, core labs, and smaller diagnostic centers. This creates a drive to consolidate PCT testing with other immunoassays and, ideally, clinical chemistry to manage these increased service demands.

By consolidating critical immunoassay and chemistry assays with unlimited configurations, labs can optimize testingand support rapid clinical decisions to improve patient care.

Comprehensive sepsis and inflammation assay menu empowering confident decision-making

Atellica Solution

Atellica CI Analyzer

ADVIA Centaur Systems

Dimension EXL 200
Integrated Chemistry System

CRP

✔

✔

✔

IL-6

✔*

✔†

Lactate

✔

✔

✔

LBP

✔*

✔*

PCT

✔

✔

✔*

✔

*Not available for sale in the U.S.
†&Բ;†&Բ;This assay has been authorized by FDA in the U.S. under an EUA for use by authorized laboratories. The IL-6 test has been authorized only to assist in identifying severe inflammatory response when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID-19 patients. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.

Performance by Design

The increasing global demand for PCT testing is driven by its critical role in early sepsis detection, antibiotic stewardship, and the fight against antimicrobial resistance.13

Key drivers for PCT testing growth are:

  • PCT testing is becoming increasingly common14, 23
  • Antibiotic stewardship initiatives4
  • Growing focus on cost-efficiency4

The increasing clinical need for early detection of sepsis has led to higher volumes of PCT testing in hospitals and clinical laboratories. Workflow efficiency, particularly in processing large volumes of tests accurately and quickly, is becoming an important operational driver for labs handling PCT.

The Atellica IM PCT assay design enhances the lab’s efficiency with fast turnaround times, long calibration intervals, and onboard stability, allowing operators to focus on high-value tasks.

Clinical Utility of PCT

Watch Jim Freeman, Head of R&D, Core Lab Solutions (CLS), speak about the extensive clinical applications of the Atellica IM B·R·A·H·M·S PCT Assay.

Atellica IM B·R·A·H·M·S PCT Assay has extensive clinical applications for your healthcare institution’s needs as an aid in sepsis and lower respiratory tract infection (LRTI) patient management.

Optimize antibiotic prescribing
Assess disease progression
Guide antibiotic discontinuation
Evaluate 28-day risk

Initiating antibiotic therapy for patients with suspected or confirmed lower respiratory tract infection (LRTI)6

Does the patient have a bacterial LRTI? Is the infection severe enough to warrant antibiotics?

PCT (ng/mL)

< 0.10

0.10 - 0.25

0.26 - 0.50

> 0.50

Recommendation forstarting
antibiotic therapy (ABx)

ABx strongly discouraged

ABx discouraged

ABx encouraged

ABx strongly encouraged

Note: Refer to the instruction for use (IFU)6 for additional information to consider for antibiotic therapy decision-making.

PCT can be used to assess disease progression 

Data support the following interpretative risk assessment criteria on the first day of ICU admission7,8:

  • PCT>2.0 ng/mL:Associated with a high risk for progression to severe sepsis and/or septic shock
  • 0.5–2.0 ng/mL:Interpret within clinical context*
  • PCT<0.5 ng/mL:Associated with a low risk for progression to severe sepsis and/or septic shock*

*Recommend retest within 6‒24 hours

Discontinuing antibiotics for patients with LRTI or suspected or confirmed sepsis6

Consider discontinuing antibiotics when:

Condition

Recommendation

Lower respiratory tract infections (LRTI)
e.g. uncomplicated pneumonia, acute exacerbation of COPD

  • ≤0.25 ng/mL OR
  • PCT has decreased >80% from the highest observed PCT result
  • + clinical improvement

Confirmed or suspected sepsis

  • PCT:≤0.50 ng/mL OR
  • PCT has decreased >80% from the highest observed PCT result
  • + clinical improvement
Note: Recheck at least once every 24-48 hours after starting antibiotics. Shorter times may be considered.

PCT can be used to determine risk of death within 28 days of diagnosis

Chart: PCT results predict 28-day mortality risk. An orange line begins at 100% on Day 0 and goes to 40% on Day 4, showing when there is a greater than or equal to eighty percent change, it is a greater risk of death. Another teal colored line also starts at 100% on Day 0, but goes to less than 20% on Day 4. When there is a greater than 80% change in PCT concentration, there is a lower chance of death.

PCT results predict 28-day mortality risk

Percent change between PCT results at baseline (day 0 or 1†) and day 4 after diagnosis predicts risk of death from any cause within 28 days of admission.

† Day 1 value can be used if day 0 value is unavailable

For every hour of treatment that is delayed, at what rate does mortality from sepsis increase?​

Assay Highlights

Assay principle

Chemiluminescent technology

Sample types

Serum or plasma
(EDTA, lithium, or sodium heparin)

Sample volume

100 μL

Auto dilution

1:20

Analytical measuring range

0.03-50.00 ng/mL*

Limit of quantitation

0.04 ng/mL

Onboard reagent stability

Atellica Solution: 60 days

Atellica CI Analyzer: 77 days

Time to first result

18 minutes

Calibration frequency (pack)

Atellica Solution: 82 days (35 days)

Atellica CI Analyzer: 82 days (77 days)

* U.S.: 0.04-50.00 ng/mL 

Trusted Results Across Analyzers

B·R·A·H·M·S PCT Assays are available on multiple analyzers from Siemens Healthineers with excellent cross-platform agreement.20-22

Also available on:

Frequently Asked Questions

​1
Trends in Hospital Inpatient Stays in the United States, 2005-2014. . Accessed Jan 2025.
2
. Centers for Disease Control. Accessed Jan 2025.
3
Samsudin I et al. “Clinical Utility and Measurement of Procalcitonin.” Clin Biochem Rev. 2017 Apr;38(2):59-68.
4
Core elements of hospital antibiotic stewardship programs. .  Accessed Jan 2025. 
5
Kyriazopoulou, et al. Am J Respir Crit Care Med. 2021;203(2):202-10. Available from:
6
Atellica IM B.R.A.H.M.S Procalcitonin assay package insert. Siemens Healthcare Diagnostics Inc. 11202687_EN Rev. 04, 2022-10
7
Harbarth, et al. Diagnostic value of procalcitonin, interleukin-6, and interleukin-8 in critically ill patients admitted with suspected sepsis. Am J Respir Crit Care Med. 2001;164:396-402.
8
Meisner M. Procalcitonin – biochemistry and clinical diagnosis. Bremen: UNI-MED; 2010. ISBN 978-3-8374-1241-3
9
Müller B, et al. Calcitonin precursors are reliable markers of sepsis in a medical intensive care unit. Crit Care Med. 2000;28(4):977-83.
10
Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96.
​11
– Quality Considerations. Accessed Oct 2024.
12
CLS Atellica Assay Menu v2 3552 07 2024
13
Global report on the epidemiology and burden of sepsis: current evidence, identifying gaps and future directions. Geneva: World Health Organization; 2020
14
IQVIA Procalcitonin 2024-2028 Market Report.
15
Meisner M. Procalcitonin - Biochemistry and Clinical Diagnosis. 1st ed. Bremen - London - Boston: UNI_MED Verlag AG; 2010:128.
16
Shiferaw, et al. The role of procalcitonin as a biomarker in sepsis. J Infect Dis Epidemiol. 2016;2:006.
17
de Jong E, van Oers JA, Beishuizen A, et al. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. The Lancet Infectious Diseases 2016;16:819-27.
18
. Accessed Jan 2025.
19
Balk RA, Kadri SS, Cao Z, Robinson SB, Lipkin C, Bozzette SA. Effect of Procalcitonin Testing on Health-care Utilization and Costs in Critically Ill Patients in the United States. Chest 2017;151:23-33
20
Atellica IM B.R.A.H.M.S Procalcitonin assay on Atellica CI  package insert. Siemens Healthcare Diagnostics Inc. 11205023_EN Rev. 04, 2023-05
21
Comparison of Atellica IM Analyzer Assays to the ADVIA Centaur System Assays White Paper published by Siemens Healthcare Diagnostics Inc. · Order No. 30-18-12669-02-76 · 08-2018
22
Introducing the Dimension EXL LOCI BRAHMS Procalcitonin (PCT) assay presentation Sept 2023 (available upon request)
23
. Accessed Jan 2025.
*
Atellica IM B.R.A.H.M.S PCT assay is intended for use, in conjunction with other laboratory findings and clinical assessments, as an aid in: 1. The risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. 2. Assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, using percent change in PCT level over time. 3. Decision-making on antibiotic therapy for patients with suspected or confirmed LRTI – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) – in an inpatient setting or an emergency department. 4. Decision-making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
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