Procalcitonin: a new biomarker for the clear indications of • Systemic bacterial infections • Severe Sepsis • Septic Shock

Rapid results in 20 minutes

One more piece to the SEPSIS puzzleONE MORE CONFIDENT DECISION

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BLOOD CULTURE

WHITE BLOOD CELL COUNT

Procalcitonin

PCT increase reflects the continuous development from a healthy condition to the most severe disease states. PCT levels in sepsis are generally greater than 0.5 – 2 ng/mL and rise in response to increasing sepsis severity.

Early detection and appropriate clinical intervention is pivotal for improving outcomes in patients threatened by sepsis. However, differentiating sepsis from other, non-infectious diseases can be difficult in patients with clinical signs of acute inflammation, including SIRS (systemic inflammatory response syndrome).

VIDAS® B•R•A•H•M•S PCT can help by providing additional, specific information that can help clinicians make more informed decisions and increase the accuracy of early sepsis diagnosis.

A Novel Biomarker of Sepsis Risk and Severity

For patients with sepsis, the first hour is critical — the first 24 hours can be decisive. Procalcitonin provides critical biomarker information that can help increase the accuracy of early sepsis diagnosis.

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SEPSISKNOW FROM DAY

PCT [ng/mL]

Clinical Condition

Healthy Local Infections

Systemicinfections(sepsis)

Severe sepsis

Septic Shock

0.05 0.5 2 10

Increased Diagnostic and Prognostic Value u Procalcitonin (PCT) is the only laboratory parameter shown to have made a significant contribution

to the clinical diagnosis of sepsis.1

u Compared to CRP (C-reactive protein) PCT has shown better differentiation of bacterial infection from non-infectious causes of inflammation.3

u Compared to serum lactate, PCT has shown to be far more predictive for sepsis.2

u PCT has been shown to provide more accurate assessment of sepsis severity than CRP,4 as well as being more predictive than CRP of severe septic complications5 and sepsis mortality risk in critically ill patients.6

PCT has demonstrated diagnostic performance superior to that of other markers for sepsis.2

1 – specificity

Sens

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0.75

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CRP

IL-6

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PCT’s unique kinetics following a bacterial challenge make it a rapid and specific marker of sepsis.8

Time (hours) Time (days)

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Day 36 12 24 Day 2210

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CRP

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Rapid, Specific Responseu PCT is distinguished from other markers by its early and highly specific increase in response

to severe systemic bacterial infections and sepsis.1,2

u Increased PCT levels can be observed within just 3 – 6 hours after an infectious challenge.

u 24-hour half-life: PCT decline is consistent with an improving clinical condition.

PCT

CRP

IL-6

IL-10

TNF-a

PCT

CRP

IL-6

IL-10

TNF-a

Time (hours) Time (days)

Plas

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Day 36 12 24 Day 2210

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CRP

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IL-10

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Sens

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1.00

1.00

0.75

0.75

0.50

0.50

0.25

0.250.00

0.00

PCT

CRP

IL-6

Lactate

bioMérieux, Inc. 100 Rodolphe Street Durham, NC 27712 U.S.A.Tel.: (800) 682 2666Fax: (800) 968 9494

bioMérieux Canada, Inc. 7815 Henri-Bourassa Boulevard West Ville St. Laurent (Quebec) Canada H4S 1P7Tel.: (1) 514 366 7321Fax: (1) 514 336 6450

www.biomerieux-usa.com/knowfromday1©20

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LimitationsIncreased PCT levels may not always be related to systemic bacterial infection.Several situations have been described where PCT can be elevated by non-bacterial causes. These include, but are not limited to:• neonates < 48 hours of life (physiological elevation)9

• the first days after a major trauma, major surgical intervention, severe burns, treatment with OKT3 antibodies and other drugs stimulating the release of pro-inflammatory cytokines10

• patients with invasive fungal infections, acute attacks of plasmodium falciparum malaria10

• patients with prolonged or severe cardiogenic shock, prolonged severe organ perfusion anomalies, small cell lung cancer, medullary C-cell carcinoma of the thyroid.10

Low PCT levels do not automatically exclude the presence of bacterial infection.Such low levels may be obtained, during the early course of infections, in localized infections and in subacute endocarditis. Therefore, followup and re-evaluation of PCT in clinical suspicion of infection is pivotal. The PCT measuring technique should be chosen according to clinical use.

References1. Harbarth S, Holeckova K, Froidevaux C, Pittet D, Ricou B, Grau GE, Vadas L, Pugin J; Geneva Sepsis Network. Diagnostic value of procalcitonin, interleukin-6, and interleukin-8

in critically ill patients admitted with suspected sepsis. Am J Respir Crit Care Med. 2001;164:396-402.2. Muller B, Becker KL, Schachinger H, Rickenbacher PR, Huber PR, Zimmerli W, Ritz R. Crit Care Med. 2000; 28:977-83. Calcitonin precursors are reliable markers of sepsis

in a medical intensive care unit.3. Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-

analysis. Clin Infect Dis. 2004;39:206-17.4. Meisner M, Tschaikowsky K, Palmaers T, Schmidt J. Comparison of procalcitonin (PCT) and C-reactive protein (CRP) plasma concentrations at different SOFA scores

during the course of sepsis and MODS. Crit Care. 1999;3:45-50.5. Castelli G. Procalcitonin as a prognostic and diagnostic tool for septic complications after major trauma. Crit Care Med 2009, 37(6): 1845–9.6. Jensen JU, Heslet L, Jensen TH, Espersen K, Steffensen P, Tvede M. Procalcitonin increase in early identification of critically ill patients at high risk of mortality.

Crit Care Med. 2006;34:2596-602. 7. Brunkhorst F.M., et. Al., Intensive Care Medicine, 1998, 24 855-892.8. Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: Analysis of incidence, outcome, and associated costs of care.

Crit Care Med 2001; 29: 1303-1310.9. Chiesa C, Panero A, Rossi N, Stegagno M, De Giusti M, Osborn JF, Pacifico L. Reliability of procalcitonin concentrations for the diagnosis of sepsis in critically ill neonates.

Clin Infect Dis 1998; 26: 664-72.10. Meisner M. Procalcitonin (PCT) – A new, innovative infection parameter. Biochemical and clinical aspects. Thieme; Stuttgart, New York, 2000; ISBN 3-13-105503-0.

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SEPSISKNOW FROM DAY

Addressing a Critical NeedSepsis threatens as many as 750,000 patients in U.S. hospitals each year — approximately 200,000 of whom do not survive.8 The need for more effective strategies to help manage sepsis is urgent. As a marker of systemic bacterial infection and sepsis, Procalcitonin (PCT) can play a critical role in addressing this clinical challenge.

Clinicians should always interpret PCT values in the clinical context of the patient. Increase in PCT reflects the continuous development from a healthy condition to the most severe consequences of bacterial infection (severe sepsis and septic shock). Therefore, optimal cut-off values for PCT are variable and dependent on factors such as the clinical setting, the site and extent of the infection, and the presence of co-morbidities.

Product Reference Tests/kit

Procalcitonin 30450-01 60

D-Dimer Exclusion™ 30442 60NT-proBNP 30449-01 60Troponin I Ultra 30448-01 60CK-MB 30421-01 30

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