EndoLISA® ELISA-based Endotoxin Detection Assay

*** Since 1 July 2016, the Recombinant Factor C (rFC)-based endotoxin test method EndoLISA® is approved for use according to chapter 5.1.10 of the European Pharmacopoeia ***

EndoLISA® is an endpoint fluorescent microplate assay intended for in vitro quantitative determination of endotoxin in pharmaceutical, biological and environmental samples.

Revolutionizing endotoxin testing with built-in sample preparation, EndoLISA® is the result of years of research and development aimed at overcoming the limitations of the LAL test. In the recently published book "Pharmaceutical Microbiology" (Wiley-VCH), Dr. Michael Rieth describes EndoLISA® as a milestone in endotoxin detection.

EndoLISA® is based on a recombinant bacteriophage protein which specifically binds endotoxin onto a microtiter solid phase. The solid phase and the capturing molecule were chosen for binding all endotoxin variants with equal affinity. After endotoxin immobilisation on the solid phase, any sample matrix with potentially interfering components is completely removed by a washing step. Therefore, the subsequent detection by recombinant Factor C (rFC) and a fluorogenic substrate is undisturbed, facilitating reliable quantification of endotoxin in the sample.

All reagents needed for running EndoLISA® are included in the kit:

EndoLISA Endotoxin Detection Test

EndoLISA®, Item no. 609033 (192 tests)

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Included: EndoLISA® Plates (2 x 96 wells), Water (endotoxin-free), Binding Buffer, Endotoxin Standard, Wash Buffer, Enzyme (recombinant Factor C), Substrate, Assay Buffer, Cover Foil.

Specifications and advantages:

  • Overcoming limitations of classical methods, such as the need for substantial dilution
  • High potential for overcoming Low Endotoxin Recovery (LER) effects; also see Endo-RS
  • No false-positive glucan reaction due to endotoxin-specific recombinant technology
  • Reduced matrix effects due to integrated wash step
  • Robust at high salt concentrations e.g. NaCl, GdnHCl
  • Excellent reliability and lot-to-lot reproducibility
  • Measurement range: 0.05 - 500 EU/ml
  • pH range: 4 - 9
  • Validation results: considerably higher tolerance for chaotropic agents, organic solvents and detergents than LAL test
  • Flexible testing format: microtiter plate
  • No animal material, therefore saving the diminishing horseshoe crab population

Additional material needed:

  • Fluorescence microplate reader
  • Plate shaker/vortex mixer
  • Incubator 37°C
  • Endotoxin-free disposables and glassware

Video user guide: