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Choose B·R·A·H·M·S PCT: Gold Standard Performance

Clinical Significance of Procalcitonin: Evidence Matters

The combination of superior sensitivity and specificity and fast kinetics is what sets PCT apart from other biomarkers when assessing bacterial infection and its severity. But not all PCT tests are the same; it’s important to know how to identify a PCT assay that sustains improvement of patient care through proven clinical, economic, and analytical performance. Only B·R·A·H·M·S PCTTM assays offer a substantial amount of clinical evidence and alignment to a gold standard, ensuring continuous clinical performance.1, 2

PCT has been extensively documented in over 10,000 publications3, including reviews, clinical trials, meta-analyses, experts’ consensus4 and international and national guidelines. Almost all this evidence has been generated using Thermo ScientificTM B·R·A·H·M·S PCTTM assays.

This strong evidence from reproducible, randomized clinical trials supports the effectiveness and safety of PCT-aided antibiotic stewardship protocols, for which only B·R·A·H·M·S PCT has an approved indication

Through an extensive evidence-based clinical performance, B·R·A·H·M·S PCT assays are the only PCT assays that have received approval for antibiotic stewardship applications.2

Furthermore, the clinical value of 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.

Non-licensed assays are missing clinical performance data in many of the applications of procalcitonin.

The Importance of PCT Quality and Evidence: Put Your Patients First

B·R·A·H·M·S PCT-aided algorithms are used to help reduce antibiotic prescriptions, deescalate therapy when appropriate and tailor the therapy duration to individual patient needs. This reduction of antibiotic exposure can benefit in shortening hospital stays, lowering antibiotic resistance and improving outcomes. In addition to improving patient care, B·R·A·H·M·S PCT allows for significant savings in healthcare costs.

*ADE: Adverse Drug Event

B·R·A·H·M·S PCT - an effective tool for antibiotic stewardship
Discover the compelling evidence for safe reduction of antibiotic exposure with B·R·A·H·M·S PCT-aided antibiotic stewardship

PCT cut-offs and clinical algorithms were established using the global reference standard assay: B·R·A·H·M·S PCT Gold Standard.

Through alignment to a validated Gold Standard, B·R·A·H·M·S PCT assays ensure reliable clinical performance in multiple indications2, making them the safe choice for patient assessment.

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. 

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

Not all PCT tests are the same. Using non-B·R·A·H·M·S PCT assays can be a risky game as their clinical performance has not been proved.

B·R·A·H·M·S PCT: Gold Standard Performance

The three pillars of B·R·A·H·M·S PCT Gold Standard performance

Validation
B·R·A·H·M·S PCT diagnostic algorithms have undergone thorough clinical validation.5-10

B·R·A·H·M·S PCT algorithms are based on cut-off values5-10

…or related to concentration changes from peak values.9,10

Accurate and safe PCT testing depends on alignment to the B·R·A·H·M·S PCT Gold Standard.1

Alignment
A rigorous quality program monitors alignment of all B·R·A·H·M·S PCT assays to the B·R·A·H·M·S PCT Gold Standard.

Monitoring of alignment to the validated B·R·A·H·M·S PCT Gold Standard sets B·R·A·H·M·S PCT assays apart from the rest.

Clinical performance
Through alignment to a validated standard, B·R·A·H·M·S PCT assays ensure clinical performance in all their applications.2

B·R·A·H·M·S PCT assays   Non-B·R·A·H·M·S PCT assays
Clinical assessment on the presence, course, and severity of systemic bacterial infections, sepsis, and septic shock.5-7
Systemic infections and sepsis
Several studies have discouraged use of the same clinical cut-offs in non-B·R·A·H·M·S PCT assays.12,13
Discordance rates up to 25.5% have been reported in non-B·R·A·H·M·S PCT assays using the 0.5 μg/L systemic infection cut-off.12,13
Aid decision making on antibiotic therapy, for patients with suspected or confirmed lower respiratory tract infections (LRTI).8
LRTI
Low-range performance of some non-B·R·A·H·M·S PCT assays has been reported to hinder application of LRTI diagnostic algorithms.11-13
Aiding of antibiotic treatment decisions in sepsis9 and LRTI,8,14 with B·R·A·H·M·S PCT has been proven to reduce antibiotic use and mortality,15,16 and the incidence of any new infection or death attributed to Clostridioides difficile or multidrug-resistant organism infections.16
Antibiotic stewardship
When discussing antibiotic decisions, authors have concluded that: “use of these clinical decision limits in non-B·R·A·H·M·S-associated assays […] could lead to overdiagnosis or […] elongated and imprecise antibiotic therapy, which […] may contribute to the development of multi-resistant germs.”12
Serial testing of patient samples with B·R·A·H·M·S PCT assays to monitor patients’ response to antibiotic therapy has been validated in several studies.8,9,14
Serial testing
Faulty serial testing of non-licensed PCT assays has been observed to potentially lead to misdiagnosis and expose patients to associated risks.13

Thermo Fisher Scientific products are distributed globally. Uses, applications, and availability of products in each country depend on local regulatory marketing authorization status, please consult the Instructions For Use (IFU) available in your country. 

The Three Pillars of B·R·A·H·M·S PCT Gold Standard Performance

B·R·A·H·M·S PCT Assays Ensure Clinical Performance Through Cross-platform Consistency

All B·R·A·H·M·S PCT assays offer excellent correlation and concordance when using the established cut-offs and algorithms.1

Learn more about implementing procalcitonin testing in your hospital.

© 2024 Thermo Fisher Scientific Inc. All rights reserved. B·R·A·H·M·S PCT and all other trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. ADVIA Centaur, Atellica IM, Dimension EXL and LOCI are trademarks of Siemens Healthcare Diagnostics. ALINITY i and ARCHITECT are trademarks of Abbott Laboratories. Elecsys is a trademark of Roche Diagnostics. LIAISON is a trademark of DiaSorin S.p.A. Lumipulse is a trademark of Fujirebio Inc. PATHFAST is a trademark of LSI Medience Corporation. VIDAS is a trademark of bioMérieux S.A. VITROS is a trademark of Ortho Clinical Diagnostics. KRYPTOR is a trademark of CisBio International, licensed for use by B·R·A·H·M·S GmbH.
Patents: www.brahms.de/patents

References
  1. Chambliss et al., J Appl Lab Med 2023; 8(3): 598-634. doi.org/10.1093/jalm/jfad007
  2. B·R·A·H·M·S PCT sensitive KRYPTOR. US IFU. B·R·A·H·M·S GmbH, 2021 (US_HN-CUS-0888 Version R21)
  3. Search term “procalcitonin” conducted  at https://pubmed.ncbi.nlm.nih.gov/. [Accessed: December 15, 2023]
  4. 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.
  5. Müller et al., Crit Care Med 2000; 28(4): 977-983. doi.org/10.1097/00003246-200004000-00011
  6. Harbarth et al., Am J Respir Crit Care Med 2001; 164(3): 396-402. doi.org/10.1164/ajrccm.164.3.2009052
  7. Brunkhorst et al., Intensive Care Med 2000; 26(2): S148-152. doi.org/10.1007/BF02900728
  8. Schuetz et al., JAMA 2009; 302(10): 1059-1066. doi.org/10.1001/jama.2009.1297
  9. Schuetz et al., Curr Opin Crit Care 2013; 19(5): 453-460. doi.org/10.1097/mcc.0b013e328363bd38
  10. Morris, Paul, and Safranek. Am Fam Physician 2016; 94(1): 53-58. aafp.org/pubs/afp/issues/2016/0701/p53.html
  11. Di Deo et al., Clin Chem Lab Med 2023, Epub ahead of print. doi.org/10.1515/cclm-2023-0776
  12. Eidizadeh et al., Practical Lab Med 2022; 30, e00274. doi.org/10.1016/j.plabm.2022.e00274
  13. Ceriotti et al., Clin Chem Lab Med 2017; 56(1): 162-169. doi.org/10.1515/cclm-2017-0159
  14. Schuetz et al., Lancet Infect Dis 2018; 18(1): 95-107. doi.org/10.1016/S1473-3099(17)30592-3
  15. de Jong et al., Lancet Infect Dis 2016; 16(7): 819-827. doi.org/10.1016/s1473-3099(16)00053-0
  16. Kyriazopoulou et al., Am J Respir Crit Care Med 2021; 203(2): 202-210. doi.org/10.1164/rccm.202004-1201oc
  17. 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.
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