EAA™ – Endotoxin Activity Assay – (Spectral Medical Inc., Canada) is the only FDA approved and CE marked rapid diagnostic assay to detect endotoxin activity in human whole blood. The EAA™ diagnostic test is performed in less than 30 minutes. EAA™ was used as a diagnostic assay to guide PMX-HP therapy in the EUPHRATES study, the largest RCT performed on polymyxin B hemoperfusion for the treatment of patients with endotoxic septic shock.
Endotoxin is the most potent trigger of the septic cascade. EAA™ is the only available assay to accurately measure endotoxin activity in whole blood. EAA™ received FDA approval in 2003 following the MEDIC study, demonstrating that elevated endotoxin activity levels are correlated with increased risk of developing severe sepsis and higher mortality. Recently, EAA™ was used as a diagnostic tool in the EUPHRATES trial to guide anti-endotoxin therapy (polymyxin B hemoperfusion, Toraymyxin®) in septic shock patients.
- EAA™ allows the evaluation of endotoxin activity in less than 30 minutes in whole blood
- EAA™ is the first diagnostic assay used to guide septic shock therapy in a RCT (EUPHRATES trial)
- EAA™ is the only FDA cleared test for detection of endotoxin in human blood
The MEDIC study evaluated the diagnostic and prognostic implications of endotoxemia in 857 critically ill patients. Endotoxin activity was measured with the Endotoxin Activity Assay (EAA). EA levels were <0.40 in 367 patients (42.8% of study group), ≥0.40 to <0.60 in 228 patients (26.6% of study group) and ≥0.60 in 228 patients (26.6% of study group). EA levels were significantly higher for patients who met the criteria for severe sepsis (0.57 ± 0.26 vs. 0.46 ± 0.26 units, p < 0.001) and the risk of severe sepsis increased with increasing levels of EA. Higher levels of EA correlated significantly with organ dysfunction. Patients with high levels of endotoxemia had increased ICU and hospital mortality. These data demonstrate the usefulness of EAA™ as a diagnostic tool in initial risk stratification and subsequent management of septic patients.