Quality Considerations for Choosing a Procalcitonin Assay

Quality Considerations for Choosing a Procalcitonin Assay

Selecting a reliable, high-quality procalcitonin test

Early diagnosis of an infection can increase the chances of positive outcomes for patients while reducing the cost of treatment. This makes selecting and adopting the right diagnostic tests a critical decision. Clinicians and lab managers must evaluate a range of factors when choosing a diagnostic test, including the benefits of clinical application, assay quality, ease of implementation, and cost.

The sensitivity and specificity for determining bacterial infection and severity together with a fast kinetic is what sets testing for procalcitonin (PCT) apart from other biomarkers. PCT testing provides the reliable data clinicians need to feel confident in their diagnoses and treatment decisions. But not all PCT tests are the same; it’s important to know how to identify a quality PCT assay.

Reference standard
Shortly after PCT was discovered 30 years ago, B·R·A·H·M·S PCT™ was introduced and used to study the clinical utility and to establish clinical cut-offs and algorithms for all of today’s PCT references. To ensure safe use of these cut-offs and algorithms, any PCT assay should be checked for its clinical equivalence to this reference test as long as no international PCT standard is available.

High sensitivity to detect bacterial infection
B·R·A·H·M·S PCT is a highly sensitive assay that will detect any subtle increase of PCT, indicating a possible bacterial infection. Therefore, choosing a high-sensitive assay allows not only for very severe cases of infection (sepsis) but also for localized infection such as lower respiratory tract infections and enables the rapid detection of patients' infectious status.

Evidence for clinical utility and safety based on published clinical trials and studies
In thousands of studies across the world over the past 25 years, PCT has been extensively investigated for its differential diagnosis, severity assessment, and prognosis of bacterial infection, as well as its role in antibiotic stewardship, most of these studies used B·R·A·H·M·S PCT. Randomized controlled interventional studies have demonstrated both the effectiveness and the safety of a PCT-aided antibiotic stewardship approach using the PCT cut-offs and algorithms established with B·R·A·H·M·S PCT. 

High concordance with relevant clinical cut-offs
B·R·A·H·M·S PCT test results are used to determine the presence of bacterial infection and to aid in the decision-making process around antibiotic therapy. For this reason, a reliable differentiation at the cut-offs is of utmost importance for ensuring that patients receive the best possible treatment.

The quality of a PCT assay can impact clinical decisions.

With a high-quality PCT test, clinicians can:

  • Minimize the chances of missing a bacterial infection because of false results.
  • Feel confident that they are providing the right level of care.
  • Ensure customized antibiotic treatment to support stewardship.
The sensitivity and specificity for determining bacterial infection and severity together with a fast kinetic is what sets B·R·A·H·M·S PCT apart from other biomarkers.

B·R·A·H·M·S PCT evidence

B·R·A·H·M·S PCT-guided algorithms are used to help reduce antibiotic prescriptions, tailor the therapy duration to individual patient needs, and decrease costs for both patients and healthcare facilities. 

Strong evidence from reproducible, randomized clinical trials with more than 10,000 patients supports the effectiveness and safety of B·R·A·H·M·S PCT-aided antibiotic stewardship protocols. PCT has been referenced in over 7,000 trials and studies, including Procalcitonin-Guided Antibiotic Therapy Algorithms for Different Types of Acute Respiratory Infections Based on Previous Trials and Procalcitonin (PCT)-Guided Antibiotic Stewardship: An International Experts Consensus on Optimized Clinical Use.2,3

B·R·A·H·M·S PCT has also demonstrated its usefulness across diverse clinical settings including the ICU, ED, pediatrics, and neonatology.

Furthermore, B·R·A·H·M·S PCT has been recognized in antibiotic stewardship guidelines issued by IDSA (Infectious Disease Society of America) and the SSC (Surviving Sepsis Campaign*), as well as by the WHO (World Health Organization), which included procalcitonin in its Essential Diagnostics List (EDL). B·R·A·H·M·S PCT is included in many national clinical guidelines and recommendations related to the management of bacterial infection and sepsis.

*The Surviving Sepsis Campaign (SSC) is a joint collaboration of the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM), committed to reducing mortality and morbidity from sepsis and septic shock worldwide.

When saving lives, quality is a necessity not to be compromised.

It is important to note there are procalcitonin assays available that claim to meet the same standards as B·R·A·H·M·S PCT, but they lack proven evidence for their clinical equivalence and safety of use. Only for assays specifying "B·R·A·H·M·S PCT" has clinical equivalence with the effective and safe application of the established PCT cut-offs and algorithms been demonstrated.

Learn more about implementing procalcitonin testing in your hospital.
Learn more about implementing procalcitonin testing in your hospital.
  1. Broyles MR. Impact of procalcitonin-guided antibiotic management on antibiotic exposure and outcomes: Real-world evidence. Open Forum Infect Dis. 2017 (Vol. 4, No. 4, p. ofx213). US: Oxford University Press.
  2. Schuetz P, Bolliger R, Merker M, Christ-Crain M, Stolz D, Tamm M, et al. Procalcitonin-guided antibiotic therapy algorithms for different types of acute respiratory infections based on previous trials. Expert Rev Anti Infect Ther. 2018 Jul 3;16(7):555-64.
  3. Schuetz P, Beishuizen A, Broyles M, Ferrer R, Gavazzi G, Gluck EH, et al. Procalcitonin (PCT)-guided antibiotic stewardship: An international experts consensus on optimized clinical use. Clin Chem Lab Med. 2019 Aug 27;57(9):1308-18.
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