B·R·A·H·M·S PCT™ sensitive KRYPTOR™ is an immunofluorescent assay used to determine the concentration of PCT (procalcitonin) in human serum and plasma. It is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.
About B·R·A·H·M·S PCT
Thermo Scientific™ B·R·A·H·M·S PCT™ (Procalcitonin) provides clinicians in the intensive care unit, emergency department and hospital wards with a sensitive, specific STAT biomarker to aid in sepsis assessment for patients in or headed to the intensive care unit.
In conjunction with other laboratory findings and clinical assessments, B·R·A·H·M·S PCT provides valuable information on the severity of a bacterial infection—both on presentation and during the course of treatment of the septic patient. The test takes just 20 minutes; therefore, results can be rapidly available to support clinical decisions.
Clinicians in health systems worldwide have relied on B·R·A·H·M·S PCT since 1996 to make patient care decisions with confidence. More than 3,000 publications in both the U.S. and Europe have demonstrated the clinical utility of PCT and defined clinical cut-offs and treatment algorithms based on the B·R·A·H·M·S PCT assay performance.
Read indications for use
Aiding Sepsis risk assessment
B·R·A·H·M·S PCT is a sensitive and specific biomarker of the inflammatory response to bacterial infection.1 PCT levels above 2.0 ng/mL indicate a higher risk for progression to severe sepsis or septic shock.2 PCT levels below 0.5 ng/mL indicate a low likelihood of progression to severe sepsis or septic shock.
This information can be obtained in emergency departments and hospital wards prior to admission to the intensive care unit to help determine both severity of illness and adequacy of source control. This initial PCT measurement provides a baseline for comparison with Day 4 PCT.
PCT concentrations and sepsis risk3-5
- Less than 0.5 ng/mL — Low risk for progression to severe sepsis and/or septic shock
- Between 0.5 and 2 ng/mL — Sepsis should be considered
- Greater than 2 ng/mL — High risk for progression to severe sepsis and/or septic shock
PCT levels must always be interpreted in the context of other laboratory findings and clinical assessments.
Aiding Septic patient management
Following ICU admission, evaluating multiple B·R·A·H·M·S PCT measurements over consecutive days aids in assessing the response to empiric antibiotic therapy. As the infection is controlled, PCT will decline daily.6 The Procalcitonin Monitoring Sepsis Study (MOSES) showed that sustained elevated PCT levels are an independent risk factor for mortality. PCT levels that decline less than 80% from the baseline within four days are associated with increased all-cause mortality, especially when the baseline PCT measurement is greater than 2.0 ng/mL.
Assessing PCT kinetics over time provides valuable information regarding patient disposition, response to treatment, and likelihood of survival.
When using B·R·A·H·M·S PCT for ICU patient management, comparing the baseline PCT level taken on Day 0/1 with subsequent measurements through Day 4, the following assessments of PCT kinetics should be considered:7
- Decrease in PCT values greater than 80% – Lower risk of all-cause 28-day mortality
- Decrease in PCT values less than or equal to 80% – two-fold higher risk of all-cause 28-day mortality
- Baseline PCT measurement greater than 2.0 ng/L – Additional information about the mortality risk when evaluating the patient’s clinical course with PCT measurements on subsequent days.
Understanding PCT Kinetics
This new video explains the unique kinetics of PCT in response to inflammatory processes resulting from bacterial infection.
Rapid and sustained response to bacterially induced systemic inflammation, and a half-life of 24 hours, are important hallmarks of PCT as a marker of sepsis risk.
Following stimulus by a bacterial endotoxin or trauma, PCT plasma concentrations:1,8
- Rise 3 to 6 hours after bacterial invasion
- Are significant after 6 hours
- Exhibit peak values between 12 to 24 hours
- Have an observed half-life of 24 hours
This rapid and sustained response to bacterially induced systemic inflammation is an important hallmark of PCT as a marker of sepsis risk.
For more information: Download B·R·A·H·M·S PCT brochure
Comparing PCT to Lactate
The sensitivity and specificity of PCT to the host response to severe bacterial infection, together with its rapid rise after an infectious challenge, offer clinical advantages that complement existing biomarkers for the clinical assessment of the septic patient.
Lactate (lactic acid) is produced due to inadequate tissue perfusion, a defining parameter of late sepsis. Reduction of lactate is advocated as a target for therapeutic interventions.9 However, lactate is not specific for bacterial infection. Clinical conditions including microcirculatory dysfunction, shunting, regional blood flow maldistribution, exaggerated aerobic or anaerobic glycolysis, hypovolemia, or arterial hypotension can increase lactate levels.10
In addition, lactate does not rise until late in the course of sepsis.11
Important considerations when interpreting PCT results
The prognostic value of PCT in the setting of sepsis has not been validated in US patients younger than 18. Increased PCT levels may not always be related to systemic bacterial infection.5,12-14
They may also be associated with:
- Injuries including major trauma, burns, and heat stroke
- Acute medical conditions such as biliary pancreatitis, chemical pneumonitis, viral hepatitis and/or decompensated severe cirrhosis (Child-Pugh Class 3), prolonged or severe cardiogenic shock, prolonged severe organ perfusion anomalies, and post-cardiac arrest
- Unusual infectious diseases including invasive fungal infections and acute plasmodium falciparum malaria
- Active medullary C-cell carcinoma, small cell lung carcinoma, and bronchial carcinoid
- Interventions such as surgery with extracorporeal circulation, treatment with drugs stimulating release of pro-inflammatory cytokines or resulting in anaphylaxis, peritoneal or hemodialysis
- Neonates during first two days of life
Dr. Eric Gluck, Chicago's Swedish Convenant Hospital
Every year, severe sepsis affects more than three quarters of a million patients—and as many as 40 percent of these patients die. Dr. Gluck explains how early identification of septic patients is crucial.
Stephen Barnes BSN, RN, Alumnus CCRN, Clinical Consultant, Thermo Fisher Scientific
Mr. Barnes provides an overview of sepsis, incidence of sepsis in the U.S., importance of early detection, treatments for sepsis, and survival rates.
Clinician and Laboratory Perspectives in Sepsis Patient Management and CMS Core Measurements
|If you missed this informative workshop at AACC 2016, here's your opportunity to learn more about strategies for managing patients with severe sepsis and septic shock.||Watch video|
The Role of PCT in Bacterial Infection and Patient Management
This webinar will discuss the role of procalcitonin (PCT) in aiding the clinical risk assessment of patients with severe bacterial infections and management of patients diagnosed with sepsis from the perspective of an ED physician and ICU physician. The speakers will discuss recent findings from the U.S. multi-site Procalcitonin Monitoring Sepsis Study (MOSES) and how repeated PCT measurements over the first four days can provide useful information regarding disease severity, adequacy of source infection control, and all-cause mortality risk.
- Brunkhorst FM et al: Kinetics of procalcitonin in iatrogenic sepsis. Intensive Care Med 1998;24(8):888-889.
- Hausfater P et al: Serum procalcitonin measurement as diagnostic and prognostic marker in febrile adult patients presenting to the emergency department. Crit Care 2007;11(3):R60. doi:10.1186/cc5926.
- Harbarth S 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(3):396-402.
- Müller B et al: Calcitonin precursors are reliable markers of sepsis in a medical intensive care unit. Crit Care Med 2000;28(4):977-983.
- Meisner M. Procalcitonin: Biochemistry and Clinical Diagnosis; UNI-MED Verlag AG; 2010.[p1]
- Soni NJ et al: Procalcitonin-guided antibiotic therapy: a systematic review and meta-analysis. J Hosp Med 2013;8(9):530-540.
- Moses Clinical Trial Data. On file Thermo Fisher Scientific
- Meisner M: Procalcitonin: experience with a new diagnostic tool for bacterial infection and systemic inflammation. J Lab Med Medicine 1999;23(5):263-272.
- Dellinger RP et al: Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med 2013;41(2):580-637.
- Thomas-Rueddel DO et al: Hyperlactatemia is an independent predictor of mortality and denotes distinct subtypes of severe sepsis and septic shock. J Crit Care 2015;30(2):439.e1-439.e6.
- Freund Y: Serum lactate and procalcitonin measurements in emergency room for the diagnosis and risk-stratification of patients with suspected infection. Biomarkers 2012;17(7):590-596.
- Meisner M et al: Postoperative plasma concentrations of procalcitonin after different types of surgery. Intensive Care Med 1998;24(7):680-684.
- Chiesa C et al: Reliability of procalcitonin concentrations for the diagnosis of sepsis in critically ill neonates. Clin Infect Dis 1998;26(3):664-672.
- Reith HB et al: Procalcitonin in early detection of postoperative complications. Dig Surg 1998;15(3):260-265.