用于鲎试剂、革兰氏鉴定和 β-D-葡聚糖检测分析的快速检测卡片

传统的内毒素检测一直存在若干不足,包括周转时间长、需要进行大量培训以及多步骤分析准备。更糟糕的是,无效检测结果可能会影响您的生产时间表。

Endosafe® 卡片技术是我们的创新解决方案,满足客户对更高灵敏度和更快定量结果的需求。该卡片技术旨在优化和完善我们对鲎试剂的使用,消除传统鲎实验方法所需的大量原材料和附件,同时减少耗时的制备工作和技术人员的差异。

降低重新测试率。减少可变性。

Endosafe 模块毫无疑问,鲎试剂是 BET 的黄金标准,虽然传统的动态检测是久经考验的可靠方法,但科学的进步可以改善它的使用方式。
下载我们的卡片使用手册

我们所有高度灵活的快速检测平台均使用 FDA 许可卡片,以及用于简单的 15 分钟检测的各种卡片。该卡片预置了执行鲎实验所需的所有试剂,无需制备多种试剂,并减少技术人员犯错的机会。

  • FLEXIBLE APPLICATIONS

    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
  • 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 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

  • PRODUCT CODES

    Charles River Endosafe LAL Cartridges

    Product Sensitivity EU/mL Code
    10 single packs of LAL test cartridges
    (FDA-licensed)
    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