The Endotoxin Activity Assay is a rapid chemiluminescent immunodiagnostic test kit that contains labeled glass tubes of specific reagents and a container of liquid substrate. This FDA cleared assay has very high sensitivity and specificity for LPS and has demonstrated a strong clinical signal with a patient’s clinical status and future outcome.

The user is required to add a measured volume (1.0mL) of the patient’s whole blood sample into certain tubes provided in an EAA™ kit. Two pipetting steps as well as a 10-minute incubation step are required for the sample/reagent reactions to occur. These reactions result in the production of light and the amount of light produced by the patient sample is proportional to the relative concentration of endotoxin. The measurement of the light emitted requires the use of a luminometer.

The EAA™ measures the endotoxin activity in whole blood by the priming of host neutrophil respiratory burst activity via complement opsonized LPS-IgM immune complexes. The luminol reaction in the presence of immune complexes emits light energy. This light energy is measured and recorded by a luminometer. The Relative Light Units (RLU) measured by the instrument is converted by a calculation into an Endotoxin Activity (EA) value which is reported as a percentage of the total possible activity (0 to 100%).