For Researchers

 

 

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 info@spectraldx.com to obtain appropriate product information for your country.

The Endotoxin Activity Assay (EAA™) is the gold standard for measuring Endotoxin Activity in human whole blood, and has been utilized in human and veterinary research projects around the world.

The EAA™ is a chemiluminescent bio-assay based on the oxidative burst reaction of activated neutrophils to complement coated LPS-IgM immune complexes. The IgM antibody, a key reagent, is specific for the Lipid A portion of endotoxin (LPS). In the presence of LPS, the ensuing oxidative burst results in light emission in the presence of luminol. Each EAA™ test relies on 3 reactions: the first reaction is a negative control which allows each patient to be their own control, the second is the test sample and the third is a maximum chemiluminescence calibrator with a high level of exogenous endotoxin. The maximum calibrator is necessary as endotoxins from different species of Gram negative bacteria have a slightly different reactivity in the EAA™.  E. coli O55:B5 is used as the standard as it has a mid-level reactivity in the assay.

The EAA™ is a highly sensitive test for endotoxin activity with the greatest sensitivity in the lowest concentration ranges of endotoxin. The dose response curve flattens in the higher endotoxin activity ranges, with no hook effect observed.

The EAA™ is a semi-quantitative test that will provide an Endotoxin Activity (EA) result. The endotoxin activity result will stratify patients into a low (<0.40), intermediate (0.40-0.59) and high (≥0.60) endotoxin activity level, allowing for stratification of patients based on endotoxin load.

Endotoxin Activity Level

 

For purchasing and further inquiries, please contact Spectral at EAA@spectraldx.com

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