Endosafe® 卡片技术

FDA-Licensed Kinetic Chromogenic LAL Cartridges

Our LAL test cartridges use existing FDA-licensed Endosafe chromogenic LAL reagent to measure color intensity directly related to the endotoxin concentration in a sample.

• Real-time quantitative endotoxin analysis in 15 minutes
• Proven USP/EP/JP-compliant BET method
• Licensed by the FDA in 2006 for in-process and final product release testing
• Detects between 0.005 and 10 EU/mL

Gram Identification Cartridges

Our Gram ID cartridge technology is a rapid assay that measures differences in the cell walls of microbial isolates. As a stain-free assay, the Gram ID cartridge eliminates procedure variability that occurs in traditional Gram stain determination.

• Reduces the need to subculture
• Capable of testing organisms <72 hours old
• Results in 3-7 minutes for Gram negative, Gram positive, and yeast and mold confirmation

Beta-Glucan Cartridges

The Beta-glucan assay is a rapid, in-process test designed for investigational purposes to ensure that products do not contain (1,3)-β-D glucans. Glucans are known to cause false-positive results in the LAL test, which could trigger an investigation.

• Designed to mimic kinetic chromogenic method by measuring color intensity
• Results in approximately 30 minutes
• Sensitivity range of 10-1,000 pg/mL

• The four reservoirs represent two pairs of sample and spike channels that allow the test to automatically run in duplicate. This design satisfies the harmonized USP/EP BET requirements for LAL testing.
• Each channel ends in an optical cell where the samples are analyzed by the reader. In the sample channels, the reader draws and mixes the sample with the LAL test reagent.
• In the spike channels, the sample is mixed with the Charles River Endosafe LAL reagent and positive control. Each sample is then combined with the chromogenic substrate and incubated.
• After mixing, the reader measures color intensity directly related to the endotoxin concentration and compares the reaction times to the ASC.

View the cartridge schematic

Charles River Endosafe LAL Cartridges

* Inhibition/enhancement screening cartridges are not licensed by the FDA

Endosafe Glucan Assay and Gram ID Cartridges

The LAL cartridge technology utilized is a kinetic chromogenic method which is a compendial method per the USP<85> or EP<2.6.14>.

Charles River offers several highly flexible rapid testing platforms to meet the needs of a variety of sample throughputs and different lab sizes and configurations. All Endosafe devices support the same LAL test cartridges for accurate, convenient, and real-time endotoxin testing, glucan concentration determination, and Gram identification.

• Endosafe^® nexgen-PTS^™ for point-of-sample testing
• Endosafe^® nexgen-MCS^™ for higher sample throughput
• Endosafe^® Nexus^™ for the central QC lab

Our FDA-licensed LAL test cartridges (license # 1197) use 95% less of the raw material required for a traditional bacterial endotoxin test. If all LAL tests were performed using this optimized technology, today’s entire worldwide LAL demand could be met with the blood from less than our current annual quota.

Learn more at hsc.criver.com

Upon receiving LAL test cartridges, run one cartridge using LAL reagent water and check values against the CofA. If they pass the cartridge lot is qualified.

For more information, visit the Endosafe Customer Portal to locate the package insert.

Store cartridges between 2 – 25°C. Do not open the pouch until you are ready to use the cartridge. If using a pack that contains more than one cartridge, be sure to keep the pouch sealed between uses.

Charles River Endosafe Cartridges are save time, require less reagents and equipment, and are able to provide quantitative results.

View a comparison study of conventional bacterial endotoxin testing and the Endosafe Cartridge Technology.

No, just the sample and LAL Reagent Water (LRW). Most samples require dilution in LRW to overcome interference. If concerned about glucans, a glucan blocking buffer (BG120) can be used and the sample can be diluted 1:1 and then run on cartridge.

Endosafe LAL cartridges are a compendial method and do not require an extensive alternative method validation. Only the regular product validation using 3 different lots of product is required.

Charles River supplies LAL cartridges with different sensitivities as the level of endotoxin that is allowed in specific products vary. Your choice of cartridge sensitivity will depend on the type of sample being tested, the endotoxin limit, and level of interference (how much dilution is required).  The Charles River Technical Support Team is here to help you choose the correct cartridge sensitivity.  Please reach out with any questions you have to [email protected].