Inflammatory Response Marker for Sepsis

The test has been cleared by the U.S. Food and Drug Administration (FDA).

Called PCT LIA (luminescence immunoassay), the test was developed by Brahms Diagnostics (Hennigsdorf, Germany; www.brahms.de). Early diagnosis and treatment of sepsis are daily challenges in intensive care units (ICUs), the company noted. Severe sepsis, which is sepsis with acute organ dysfunction, is the number one cause of death in noncoronary ICUs. Cases are expected to rise in the future, partly because of the widespread use of antibiotics that encourage the growth of drug-resistant microorganisms. In spite of enormous investment in critical care resources, severe sepsis mortality ranges from 28-50%.

"It is clear that elevation in procalcitonin offers the clinician a significant correlation with infection and severity of infection,” commented Dr. R. Phillip Dellinger, director of critical care medicine at Cooper University Hospital (Camden, NJ, USA). "Clinical utility in select patient populations has already been identified and our center and others continue to work to discover the optimal utilization of this marker as it relates to patient management.” Procalcitonin PCT is already available in numerous European hospitals and will now become available to doctors in the United States.

"Today, this test has established a place in our clinical routine for the diagnosis and therapy direction of sepsis,” noted Prof. Konrad Reinhart (Jena, Germany), a clinical scientific pioneer in procalcitonin PCT testing. "The availability of PCT in the United States will encourage more international clinical-scientific cooperation on this subject.”





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