Blood Test Biomarker Aids Risk Assessment of Sepsis

A clinical immunoassay enables rapid and accurate risk assessment of critically ill patients for severe sepsis and septic shock.

The assay is for Procalcitonin (PCT), a protein that can be used as a marker for sepsis caused by severe bacterial infections. Unlike other sepsis biomarkers, it can be elevated much earlier in the condition.

Blood samples can be prepared and analyzed in just 19 minutes and patient results delivered one hour from taking the blood sample. In addition, levels of PCT in the human body correlate to the severity of the infection, enabling a more accurate and detailed assessment. The B.R.A.H.M.S. PCT assay (Thermo Fisher Scientific, Waltham, MA, USA) has made a significant contribution to clinical risk assessment in sepsis in critically ill patients when admitted to the ICU. At a decision making point of 2 ng/mL, PCT displayed a sensitivity of 99% and a specificity of 77% in differentiating patients on their first day of intensive care unit (ICU) admission with systemic inflammatory response syndrome (SIRS) and sepsis from those with severe sepsis and septic shock.

One of the main benefits of measuring PCT levels is that it is specific to severe bacterial infections, and does not rise in cases of viral infection. Therefore, application of PCT in Europe and the rest of the world have also been shown to predict accurately the absence of the condition early in the diagnosis stage, reducing costs and unnecessary antibiotic use. The PCT assay is already established in Europe, particularly Germany, France and Switzerland, where it has been used for risk assessment of sepsis in patients for more than ten years. The PCT received 510(k) clearance by the US Food and Drug Administration (FDA, Silver Spring, MD, USA), in April 2008.

Sepsis is characterized by a whole-body inflammatory state due to a systemic infection. In the US, incidence of sepsis is rising at an estimated 1.5% annually. Mortality rates range from 25% to nearly 50% and each hour of delay in therapy can decrease survival by 7.6%. Andy Thomson, president of Clinical Diagnostics at Thermo Fisher Scientific, said, "PCT has proven an effective tool for sepsis in Europe and is expected to become standard in the US as the industry learns more about its unique capabilities."

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