Endotoxins are part of the cell membrane from gram-negative bacteria. When released into a host organism after cell decay, endotoxins can cause serious pyrogenic effects. Detecting the amount of endotoxin in pharmaceutical products, which enter the human bloodstream, is therefore a mandatory step performed by laboratories.
The bioMérieux endotoxin detection assay document provides all necessary tools to analyze endotoxin concentration as suggested by bioMérieux. The add-on comes with templates to support the 96-well test kits ENDOZYME® II (Go) and ENDOLISA® from bioMérieux. You can also define custom assay templates to use with your own assay configuration. Choose between linear and non-linear regression models to fit data of your reference standard.
Prepare test samples by adding information about the threshold value of endotoxin concentration or the spike of the respective positive product control (PPC). Further add blank controls to use them as the baseline for the linear model approach and to determine assay validity.
Results show the activity of test samples in relation to the reference standard, and the recovery rate of spiked PPCs. Assess the validity of your assay with configurable tests on regression parameters, PPC recovery rate, blank control development, or the variation in estimated endotoxin concentration.
The bioMérieux endotoxin detection assay document also allows for the calculation of the optimum gain to qualify plate reader sensitivity. Create print-ready PDF reports or use the CSV format for further processing.