For Clinicians

Endotoxin and Sepsis


EAA™ and PMX are licensed and available for use in Canada. PMX is not approved for clinical use in the USA, and is currently undergoing the PMA (Premarket approval) process. EAA™ is FDA cleared for use in the USA. The information presented herein is region specific. Please contact Spectral Medical Inc. at to obtain appropriate product information for your country.

Endotoxin is a major component of the cell wall of Gram Negative bacteria and is the principle molecule responsible for the induction of septic shock

Elevated levels of endotoxin can often induce fever, changes in white blood cell counts and, in some cases, cardiovascular shock. EAA™ is a rapid test that allows the analysis, in approximately 30 minutes, of the endotoxin activity in whole blood samples. This is the only commercially available diagnostic test to measure endotoxin activity that is approved by the US Food and Drug Administration (FDA) and licensed by Health Canada.

More specifically, the EAA™ test allows:

Stratification of patients based on their risk of developing septicemia within 24 hours.1

Odds ratio for Severe Sepsis

A prospective cohort study (MEDIC study) of  857 consecutive new patients to ICU evaluated the usefulness of EAA™ as a diagnostic tool in sepsis and septic shock.  Specifically, the study was carried out in order to determine the prevalence of endotoxemia in the critically ill as well as to determine if any association exists between EAA™ values at time of admission to ICU and disease outcome. Results of the study indicate that rate of endotoxemia was quite high in critically ill patients: 26.6% of the cohort had EA levels 0.4-0.6 and 30.6% of the cohort had EA levels ≥0.6. Further analyses showed that for the 74 patients meeting the criteria for severe sepsis, EA levels at the time of ICU admission were significantly higher (0.57±0.26  vs. 0.46±26, P<0.001). Multivariate regression analysis of the data uncovered that EA levels at time of admission had a significant association with the development of severe sepsis on day of ICU admission, either as a continuous variable (P=0.02) or as a categorical one (P=0.0001); when patients were stratified based on EA levels to low (<0.4), intermediate (0.4- 0.6) and to high (>0.6) groups, it was noted that the odds of developing severe sepsis in the first 24 hrs of ICU admission was  2.0 (95% CI) for the intermediate group and 3.0 (95% CI) for the high group. These data strongly indicated the usefulness of EAA™ as a diagnostic tool in initial risk stratification and subsequent management of septic patients.1

EAA™ Distribution

Healthy (A) vs. ICU (B)1

Endotoxin level Healthy vs. ICU

Selection of patients for endotoxin removal therapy with PMX

Patient selection for endotoxin removal therapy with Toraymyxin

1. Diagnostic and Prognostic Implications of Endotoxemia in Critical Illness: Results of the MEDIC Study.

JC Marshall, D Foster, JL Vincent, DJ Cook, et al., Journal of Infectious Diseases, Aug. 2004.


2.  For more information, please visit Identifier #: NCT01046669 or visit the EUPHRATES section.



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