Infection and sepsis are among the most substantial causes of morbidity and mortality worldwide. The CDC estimates that one in three patients who die in a hospital are septic. While the clinical laboratory plays an essential role in the diagnosis and management of infectious diseases, labs historically have been hampered by a lack of accurate and rapid diagnostic tools.

Now, emerging evidence is opening up a new path that combines novel biomarkers, promising molecular assays, and powerful data analytics. A scientific session titled “Emerging Diagnostics for Early Detection of Infection: Experiences from the ICU Using Novel Biomarkers and Informatics” tackles this issue head-on, helping prepare laboratorians to implement the newest technologies for infectious disease testing.

While traditional microbiology methods such as bacterial culture remain crucial for the identification of infectious pathogens, the entire laboratory plays a vital role in the management of patients with an infection. According to Jessica Colon-Franco, PhD, director of clinical biochemistry at the Cleveland Clinic and a speaker at this scientific session, “the entire clinical laboratory and even informatics have become increasingly important for the early detection and management of septic patients.”

As examples of this, laboratories have used C-reactive protein as a non-specific marker for inflammation and lactate as a marker of more severe infection for years. Thus, the goal of this session is to describe the limitations of biomarkers currently in use and to shed light on many of the emerging technologies and biomarkers.

One of the shortcomings of many traditional biomarkers is that they simply are not good enough for diagnosis. “There currently is not a biomarker that accurately and rapidly identifies infected or septic patients” Colon-Franco says. “Most biomarkers lack sensitivity or specificity, leading them to have a niche role in clinical practice.”

This has led to the emergence, at least experimentally, of novel markers such as cytokine panels and combinatorial markers into a prognostication score. However, these new approaches have not been widely adopted in clinical practice.

One of the hottest areas in the development of sepsis diagnostics is molecular testing. According to another speaker, Tim Sweeney, MD, PhD, CEO of Inflammatix, winner of the 2019 AACC Disruptive Technology Award, rapid molecular diagnostics will be crucial for detecting infection and predicting severity in the near future. “The current biomarkers in use are not particularly helpful for pathogen detection” Sweeney says. “They tell you risk for infection or developing sepsis. In contrast, molecular testing can detect active infection and can accurately predict if the infection is bacterial or viral.”

How does a molecular blood test for diagnosing infection work? According to Sweeney, “rapid molecular assays measure mRNA from the cellular, host immune response.” Therefore, using the host transcriptome, molecular testing can identify potentially infected patients and can also help discriminate bacterial from viral infections. Sweeney explains that “…sepsis is often conflated with bacteremia, but not knowing if an infection is a bacterial or viral infection, is a considerable shortcoming.” The hope for rapid molecular testing is that it will help identify infected patients far earlier, well before a patient becomes septic.

Attendees can anticipate that this session will present a bright future ahead for rapidly diagnosing and managing infections. According to Colon-Franco, “biomarkers of the future will likely be combined into a prognostication score.”

On the molecular front, the next frontier is sepsis therapy selection. Future molecular markers may help us to know which therapies to administer that will effectively modulate the immune system and improve outcomes,” Sweeney says. Ultimately, he predicts that sepsis diagnostics and treatment will someday look much like personalized medicine and cancer diagnostics, with specific inflammatory profiles potentially treatable by different therapeutics.

This session highlights the collaborative nature of the clinical laboratory in helping solve complex clinical problems, and it’s a can’t miss for any laboratorian.