Unlock the Power of Endotoxin Analysis

Analyze the endotoxin concentration in a substance. Use our bioMérieux Endotoxin Detection Assay Package to analyze the bioMérieux assay kits EndoLISA® and ENDOZYME® II GO. Simplify your reporting process by effortlessly creating professional PDF reports. Additionally, take advantage of our data export capabilities for external data processing.

Effortlessly streamline your assay analyzing process with intuitive configuration options and adjustable templates. Use our state-of-the-art software to accurately fit linear or 4-parameter logistic models to your reference standard, enabling precise calculations of assay sample activity and spike recovery from positive product controls. Easily optimize instrument sensitivity by calculating ideal amplification while ensuring assay validity through comprehensive testing of regression parameters, recovery, coefficient of variation, and blank control development. Seamless documentation of instrument settings and operator information for a smooth and efficient workflow are a given.

Note: Use our Tecan MagellanTM Import Module for bioMérieux Endotoxin Assays to conveniently import data into PLA 3.0. For further information, please visit 'Tecan Magellan™ Import Module for bioMérieux Endotoxin Detection Assays'

What's New in the bioMérieux Endotoxin Detection Assay Package 1.0.1 for PLA 3.0

Sample plots

Pic. 1
Pic. 2

pic.1 - Standard curve of the 4-parameter logistic model
pic.2 - Standard curve of the linear model

Features

  • Analysis of endotoxin concentration
  • Setup of endotoxin limits
  • Validity assessment via spiked samples
  • Linear and 4-parameter logistic models
  • Adjustment of instrument sensitivity (gain optimization)
  • Predefined assay templates for bioMérieux test kits
  • Configurable assay layout and test system
  • Documentation options about the operator and instrument
  • PDF and CSV reports

Basic concept

The bioMérieux Endotoxin Detection Assay Package is based on the bioMérieux methodology for calculating endotoxin concentration in samples. This includes support for all types of assay systems, extensive documentation options, statistical features such as weighted regressions, optimal gain of the instrument, and a configurable test system combined into a single PLA 3.0 document. You can define any number of test samples, their endotoxin limit and the spike amount of the related positive product control. Select either the linear or 4-parameter logistic model as fit for your reference standard. Then provide measurements from the first and final time point. Interpolation analysis estimates the endotoxin level in test samples and the amount of recovered spike material for a thorough identification of valid or invalid samples. A configurable test system further checks for the validity of the assay.

Use cases

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.

Example

  • Sample Report for a bioMérieux endotoxin assay using the 4-parameter logistic model 77 KB
    This report shows an example of the execution of an ENDOZYME® II GO assay. It uses a Standard with 5 dilution steps (50 - 0.005 EU/mL) fitted via a 4-parameter logistic curve. The plate is filled with 20 samples. One half uses a release limit of 0.05, the other half a limit of 1.
  • Sample Report for a bioMérieux endotoxin assay using the linear model 76 KB
    This report shows an example of the execution of an ENDOZYME® II GO assay. It uses a Standard with 4 dilution steps (5 - 0.005 EU/mL) fitted via a linear curve. The plate is filled up with 20 samples. The upper half of the samples uses a 1:2 predilution. The lower half is not prediluted. A release limit of 0.05 is applied to each sample.
  • Sample Report for a bioMérieux endotoxin assay executing the Morning test 34 KB
    This report shows the execution of the Morning test for an endotoxin detection assay. The plate setup uses one strip, and columns 1 & 2 are filled with Standard concentrations. Besides the normal evaluation of the curve fit, it is checked whether the current gain of the instrument is correctly calibrated. This is verified by comparing the CV of the measured dRFUs on the chosen Standard concentration (=0.5 EU/mL) to an upper bound. In the example, the gain succeeds the test. In fact, its result and validity of the gain optimization does not influence assay validity at all and can be seen as an informative remark for the user.