A new rapid microbiology method is being marketed for endotoxin testing. The EndoLISA has been developed by a company called Hyglos and was launched on 1st September 2011.
Hyglos has developed and optimized a lipopolysaccharide (LPS) specific phage-derived protein as well as optimal sample conditions, in order to specifically cover the entire substance group of LPS (endotoxin). The phage protein is pre-coated to the wells in the EndoLISA® microtiter plate and as the sample is added to the well, the endotoxin (LPS) in the sample is bound to the phage protein. Any sample matrix with potentially interfering components is then completely removed by a washing step. Therefore, the subsequent detection by recombinant Factor C and a fluorescence substrate is left unaffected by inhibitors, facilitating a reliable quantification of endotoxin in the sample.
The key marketing point with the system is that samples do not require dilution in order to overcome inhibition or enhancement (interference). The system can assess samples within the pH range: 4 – 9. The measurement range is between 0.05 - 500 equivalent EU/ml units. This is slightly less sensitive than some LAL methods which have a sensitivity to 0.001 EU/ml.
The system is a variation from the methods described in both the United States and European Pharmacopoeias and stands as an investigational tool at present.