Rapid Test Cartridges for LAL, Gram ID & Beta-D-Glucan Detection Assays
Traditional endotoxin testing has long had pain points, including long turnaround times, extensive training, and multiple steps for assay preparation. To make matters worse, an invalid test result can potentially cripple your manufacturing timelines.
The Charles River Endosafe® cartridge technology is our innovative response to our customers’ need for higher sensitivity and faster quantitative results. Designed to optimize and refine our use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional LAL testing methods while reducing time-consuming preparation and technician variability.
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There’s no mistake that the LAL reagent is the gold standard for BET, and while conventional kinetic testing is a tried and trusted method, advances in science have allowed for improvement in how it’s utilized.All of our highly flexible rapid testing platforms utilize our FDA-licensed LAL cartridges as well as a variety of non-regulated cartridges for simple, 15-minute testing. The cartridges are pre-loaded with all of the reagents required to perform an LAL test, eliminating preparation of multiple reagents and reducing the opportunity for technician error.
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FLEXIBLE APPLICATIONS
FDA-Licensed LAL Cartridges
Our LAL 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 CartridgesOur 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 CartridgesThe 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 LAL assays, 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
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CARTRIDGE FUNCTIONALITY
- 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 reagent.
- In the spike channels, the sample is mixed with the Charles River Endosafe® LAL reagentand 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.
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PRODUCT CODES
Charles River Endosafe® LAL Cartridges
Product Sensitivity EU/mL Code 10 single packs of cartridges
(FDA-licensed)0.1 PTS201F 0.05 PTS2005F 0.01 PTS2001F 0.005 PTS20005F 10 single packs of cartridges
(unlicensed: for R&D use only)0.1 PTS201 0.05 PTS2005 0.01 PTS2001 Multi-packs of 25 cartridges
(5/pouch) (FDA-licensed)0.05 PTS5505F 0.01 PTS5501F 0.005 PTS55005F 10 single packs of inhibition/enhancement screening cartridges* PTS220 * Inhibition/enhancement screening cartridges are not licensed by the FDA
Endosafe® Glucan Assay and Gram ID Cartridges
Product Code Beta-Glucan cartridges (10/pack) RMMGS1000
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to reach your organization's goals? |
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With companies looking for ways to increase their data integrity compliance and operational efficiencies, simply answer these 5 questions to see which endotoxin test method is best for your organization’s testing requirements. |
Frequently Asked Questions (FAQs) About Endosafe® Cartridge Technology
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Which endotoxin testing instruments can be used with Charles River Endosafe® LAL cartridges?
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 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
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Do Endosafe® cartridges use less LAL than other BET methods?
Our FDA-licensed LAL 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.
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How do I qualify a new Charles River Endosafe® LAL cartridge lot?
Upon receiving 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.
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How do I store Endosafe® LAL reagent cartridges?
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.
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What are the benefits of Endosafe® cartridges over traditional LAL?
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.
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Do I need any special reagents to run my sample with Endosafe® LAL cartridges?
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.
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Are Endosafe® LAL cartridges a compendia method?
Yes, they are a kinetic chromogenic method.
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Do I need to perform an alternative method validation?
The 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.