When Good Biomarkers Go Bad: Effectively Utilizing Procalcitonin (PCT) for Sepsis Management to Demonstrate the Value of the Lab

DATE:  October 5, 2016
TIME:  10:00am PT, 1:00pm ET

Sepsis, a host-mediated response to a systemic infection, is a leading cause of mortality worldwide (1).  Early recognition of infection and initiation of effective therapy is essential to reducing mortality from sepsis; every hour that effective therapy is delayed causes an 8% increase in mortality (2).  Sepsis management is now a Centers for Medicare & Medicaid Services (CMS) core measure, and includes a number of required laboratory measurements.  One of the most effective biomarkers for sepsis is procalcitonin (PCT) which has demonstrated excellent sensitivity to sepsis.  This biomarker puts laboratory leaders in a unique position to greatly impact sepsis protocol by providing a solution that can aid in early identification of systemic bacterial infection, assess mortality risk and guide antimicrobial effectiveness (3). Unfortunately, the utility of PCT has been limited in clinical practice by its availability and turnaround time (TAT).  This talk will focus on the role PCT can play in recognizing and managing sepsis as well as the relevant operational features (TAT, availability) and institutional buy-in necessary to achieve maximum utility from this marker of sepsis and the unique opportunity it presents for lab leaders to bring more value to the laboratory.

Learning Objectives:
At the conclusion of this talk, attendees should be able to…

1. Summarize the requirements and implications of the new sepsis CMS core measure
2. Explain the role of PCT in identifying and managing sepsis
3. Decide on the required clinical performance necessary for PCT to be impactful, especially with regards to turnaround time (TAT) and test availability
4. Understand how lab leaders should position PCT with key stakeholders to maximize adoption and clinical utility.

Works Cited:

1. Singer M, Deutschman CS, Seymour C, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 315(8) (2016) 801-810.
2. Kumar A, Roberts D, Wood K, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit. Care Med. 34 (2006) 1589–1596.
3. Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin Algorithms for Antibiotic Therapy Decisions: A Systematic Review of Randomized Controlled Trials and Recommendations for Clinical Algorithms. Arch Intern Med. 171(15) (2011) 1322-1331.

Roche Diagnostics is proud to announce the recent FDA Clearance for the Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. With this clearance, Roche is the first IVD company in the U.S to join the fight against sepsis with a fully integrated solution, giving clinicians greater clarity when it matters most. The Elecsys BRAHMS PCT assay can help rapidly confirm bacterial infection in minutes, accurately assess mortality risk and assist clinicians in safely de-escalating antiobiotic treatment and provides a powerful opportunity for lab leaders to demonstrate the value of the lab throughout the continuum of care.