Study Shows Effectiveness of Spectral Diagnostics EAA Sepsis Assay

A major peer reviewed article on the performance of a new sepsis assay from Spectral Diagnostics, Endotoxin Activity Assay (EAA), was recently published in the Journal of Infectious Diseases.

The article titled, Diagnostic and Prognostic Implications of Endotoxemia in Critical Illness: Results of the MEDIC Study was authored by Dr. Marshall, Professor of Surgery of University of Toronto, lead investigator for the study. The MEDIC study was a multi-national, multi-center prospective clinical trial evaluating Spectral’s EAA for use in the Intensive Care Unit.

The results of the MEDIC study showed that endotoxemia is present in more than one-half of all patients upon admission to the ICU. Dr. Marshall reports "patients with high levels of endotoxin were clearly a sicker group of patients and had a significantly higher risk of dying while in the ICU. In addition, the presence of high levels of endotoxin correlated significantly with the risk for severe sepsis".

Sepsis is a disease that is common, deadly and a costly complication in critically ill patients. Sepsis is difficult to diagnose in its early stages, at a time when treatment has the greatest benefit. Endotoxin is the "toxic" component of Gram negative bacteria such as E. coli and Salmonella. It has long been recognized as playing a pivotal role in sepsis but until now, there has not been a reliable, clinically useful method of measuring it.

The Endotoxin Activity Assay is a rapid, whole blood test. The test relies on the reaction of endotoxin with antibody, which is amplified by the patient's neutrophils in whole blood resulting in an enhanced respiratory burst in the presence of zymosan, detected by luminol chemiluminescence.

The magnitude of the priming influence is proportional to the concentration of antigen-antibody complex.

The paper can be found at The Journal of Infectious Diseases 2004;190:527-534