Assays Urgently Needed to Monitor the Progression of Sepsis

There is no gold standard for diagnosing sepsis because symptoms can be vague and/or overlap with other diseases.

Three surveys were conducted among clinicians to assess opinions regarding bacterial sepsis in U.S. hospitals and the importance of new technologies and/or methods to solve current complexities surrounding diagnosis and treatment.

Sepsis is an inflammatory response to an infection. Nonspecific symptoms include elevated heart rate, rapid breathing, and fever. Septicemia can rapidly progress to sepsis and then to septic shock, in which the immune system mounts an overwhelming response to an infection, causing widespread blood clotting and inflammation, which is often more dangerous than the infection. Septic shock brings on a dramatic drop in blood pressure and organ failure. As many as 750,000 people in the United States alone are diagnosed with severe sepsis each year, and 200,000 of these patients do not survive.

Over 90% of the physicians surveyed reported that they need a tool that would help them monitor the progression of sepsis over a 24-hour period because the condition can so rapidly turn fatal. Patients with suspected sepsis are treated with antibiotics, but there is no reliable way to know if that treatment is effective. A physician frequently learns that treatment is insufficient only when the patient progresses into septic shock.

BioMerieux (Durham, NC, USA) announced the results of the surveys, which were fielded during conferences of the American College of Chest Physicians (CHEST), the American College of Emergency Physicians (ACEP), and the Society for Critical Care Medicine (SCCM) in 2009.

BioMerieux developed the Vidas B.R.A.H.M.S PCT, a 20-minute test to detect levels of procalcitonin (PCT), a sign of systemic bacterial infection. The Vidas B.R.A.H.M.S PCT, an enzyme-linked fluorescent assay, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) for assessing a patient's risk of progression to severe sepsis and septic shock. PCT, the prohormone of calcitonin, can be produced by numerous cell types and organs after proinflammatory stimulation, especially when caused by bacterial infection, making PCT an ideal indicator of systemic bacterial infection and sepsis.

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U.S. Food and Drug Administration