Multiple sample analysis of endotoxin detection for the future

Endosafe^®-MCS™ System, is build on the strength of the portable PTS™. The Endosafe^®-MCS™ is a multi-cartridge endotoxin detection system (MCS™) that utilizes FDA licensed LAL test cartridges and multiple spectrophotometers to provide endotoxin test results for up to five samples in about 15 minutes.

The MCS™ provides quantitative LAL test results flexibly and easily. Results are captured via Endo-Scan-V™, Charles River’ 21 CFR compliant endotoxin detection software. The software provides detailed reports and can be linked to Endosafe^® MicroTrend for data trending and analysis.

Test Technology
The Endosafe^®-MCS™ uses LAL kinetic chromogenic methodology that measures color intensity directly related to the endotoxin concentration in a sample. Disposable cartridges contain precise amounts of LAL reagent, chromogenic substrate and control standard endotoxin (CSE). The cartridges are manufactured according to rigid quality control procedures promoting test accuracy, consistency, and product stability.

The system is comprised of five individual spectrophotometers built into a unit with a single USB connector that links to a desktop computer.

Test Procedure
To perform the test, simply pipette 25 µl of a sample into each of the four sample reservoirs of the cartridge. The reader draws and mixes the sample with the reagents. After mixing, the optical density of the wells is measured and analyzed against an internally-archived standard curve. By design, the 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.

Advantages of Endosafe^®-MCS™

• FDA-licensed endotoxin detection system
• Test multiple samples simultaneously
• High throughput for real-time results
• Single step, quantitative LAL test
• LAL test components all included
• Four levels of sensitivity: 0.005 EU/mL, 0.01 EU/mL; 0.05 EU/mL; 0.10 EU/mL
• Results can be tracked and trended via EndoScan-V™ and MicroTrend™
• Sophisticated data management and reporting capabilities

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