- Specific endotoxin test based on ELISA principle. Endotoxin is bound to a microwell plate by a LPS-specific phage protein. After washing off the sample matrix, bound LPS is detected using a recombinant Factor C and a chromogenic peptide substrate.
- EndoLISA® from Hyglos GmbH is used for analysis.
- Sensitivity range: 0.05 EU/ml – 500 EU/ml
- Specificity: LPS
- Interference: low interference due to removal of sample matrix by a washing step
- Low interference due to solid phase-based assay principle. Suitable for complex samples.
- No activation by ß-glucan
- Less dilution required
- One order of magnitude less sensitive compared to LAL and recombinant Factor C assay.
- Alternative method according to European Pharmacopoeia, chapter 5.1.10 and FDA (Guidance for Industry 06/2012).