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 LAL 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 in the kinetic chromogenic method. 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.

Technician performing assay for host cell proteins (HCPs) in a lab.

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All of our highly flexible rapid kinetic chromogenic LAL 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.


    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

    Product Sensitivity EU/mL Code
    10 single packs of LAL test cartridges
    0.1 PTS201F
    0.05 PTS2005F
    0.01 PTS2001F
    0.005 PTS20005F
    10 single packs of LAL test cartridges
    (unlicensed: for R&D use only)
    0.1 PTS201
    0.05 PTS2005
    0.01 PTS2001
    Multi-packs of 25 LAL test 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
Charles River's comprehensive biologic testing solutions includes stability testing

Did you know Endosafe LAL cartridges
are a compendial BET method?

FDA-licensed Endosafe LAL cartridges are a kinetic chromogenic LAL method as specified in the EP/USP and JP. See the regulatory requirements here:

FDA Guidelines

USP BET <85> or BET <2.6.16>

Frequently Asked Questions (FAQs) About Endosafe Cartridge Technology