Endotoxine Determination

For the routine determination of endotoxins Elysia has chosen the Endosafe NexGen from Charles River Laboratories. The system is a FDA licensed endotoxin detection system. It is a rapid point of use test system that provides quantitative test results in less than 15 minutes. The technology utilizes licensed LAL reagents in a disposable cartridge using the PTS for a completely contained, real time endotoxin assay. The PTS is perfect in a conventional quality control setting and is fully implemented in Elysia Turn-Key solutions. The Endosafe uses LAL kinetics chromogenic methodology that measures a colour intensity that is directly related to the endotoxin concentration in the sample. Each cartridge contains precise amount of LAL reagent, chromogenic substrate and a control standard of endotoxin (CSE). The cartridges are manufactured according to rapid quality control procedures promoting test accuracy, consistency and product stability. To perform the test, the user simply pipettes 25μl of a sample into each of the four sample reservoirs of the cartridge. The reader draws and mixes the sample with the LAL reagent in two channels (sample channels) and with the LAL reagent and positive product control in the other two channels (spike channels). The sample is incubated and then combined with the chromogenic substrate. After mixing, the optical density of the wells is measured and analysed against an internally-archived standard curve. By design, the PTS cartridge automatically performs a duplicate sample/ duplicate positive product control LAL test, thereby satisfying the harmonized USP Bacterial Endotoxin Test (BET) and the FDA guideline for LAL testing.

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