细菌内毒素检测 (BET)

作为最灵敏和最强大的检测方法,鲎试剂已从定性凝胶检测转变为生产现场可用的 15 分钟定量测定。Charles River 一直处于内毒素检测研发的最前沿,并投资开发新技术和创新产品,以提高检测质量并加速开发过程。我们特意针对快速和传统的细菌内毒素检测建立了 FDA 许可产品组合,以降低重检率并缩短周转时间,使您能迅速、自信地对产品安全性做出决策。


Charles River 细菌内毒素检测组合

技术人员使用 Endosafe nexgen-PTS 进行内毒素快速检测内毒素检测系统:Charles River 的 Endosafe® 系统简化内毒素检测。灵活的解决方案可满足每个客户的需求,适合各种样品量或行业。从过程中检测到最终批次放行,我们易于使用的 Endosafe® 模块技术产品可提供快速、准确的结果,提高鲎试剂的效率。我们销售的每个系统都由熟练的技术团队提供支持,他们可以提供培训、维护和支持。

科学家在计算机上使用 Cortex 内毒素检测数据跟踪和趋势化软件内毒素检测软件:我们的内毒素检测软件采用专门设计,通过实现定量结果以及结合灵活的配置功能来帮助减少变化并提高运营效率。



Endosafe 鲎试剂模块技术鲎试剂与附件:我们的鲎试剂已获得 FDA 产品放行许可,所有附件产品均经过认证,满足相应的鲎实验要求。这些产品具有极高的精度和可靠性,最大限度减少无效结果和重新检测的需要。


索取报价 / 信息

如果您能获得一致性更高、更可靠的 BET 结果,同时还能保持 FDA 合规,这会如何?

Endosafe 模块只需回答以下 5 个问题,即可了解哪种快速技术可以帮助您减少分析师培训和重检率,并消除数据输入、收集和解释中的人为错误。回答问题

  • What is bacterial endotoxin?

    A bacterial endotoxin is a type of pyrogen (a fever-causing agent) and is found in the cell wall of Gram-negative bacteria. If certain amounts of endotoxin are introduced into the bloodstream or spinal fluid via a parenteral drug or medical device, fever, septic shock, organ failure, or death can occur. Due to the possibility of serious illness or death, all injectable pharmaceutical products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins to ensure patient safety. These products and devices are tested for endotoxins with a bacterial endotoxin test (BET). The most popular BET test utilizes LAL (limulus amebocyte lysate) to detect bacterial endotoxins. Charles River offers a variety of bacterial endotoxin test FDA-licensed LAL reagents including the exclusive Endosafe® LAL cartridge technology.

     

  • What products need to be tested for endotoxin?

    All injectable pharmaceutical products and implantable medical devices need to be tested to ensure there is no presence of endotoxin, which can lead to a pyrogenic response (fever) and symptoms of septic shock. Endotoxins can be detected in these products and devices through bacterial endotoxin testing (BET). The most popular bacterial endotoxin test uses LAL (limulus amebocyte lysate) to test for bacterial endotoxins. Charles River offers FDA-licensed LAL reagents for gel-clot, kinetic chromogenic, and kinetic turbidimetric BET test methods including the proprietary Endosafe LAL cartridge technology.

  • What is a rabbit pyrogen test?

    The rabbit pyrogen test (RPT) is performed to check for the presence of pyrogens in products that could contain a Gram-negative or Gram-positive bacteria. Rabbits are used because their body temperature increases when they are injected with a pyrogenic product. From 1942 to 1983, the rabbit pyrogen test was the standard for pyrogen testing; however, it was labor-intensive, lengthy, and expensive. In 1983, the FDA and US Pharmacopeia adopted the bacterial endotoxin test utilizing Limulus amebocyte.

  • What is the difference between a Pyrogen Test and a Bacterial Endotoxin Test (BET)?

    As an endotoxin is a type of pyrogen, both assays test for harmful Gram-negative bacteria that can produce life-threatening symptoms if introduced into the bloodstream or spinal fluid. The rabbit pyrogen test is an in vivo (performed inside of a living organism) test to detect pyrogens. If a rabbit is injected with a pyrogenic product, its body temperature will increase making it possible to determine the presence of pyrogens. However, the RPT is prone to errors and can result in the rabbit's death.

    A bacterial endotoxin test (BET), such as LAL (limulus amebocyte lysate), is an in vitro assay used to detect bacterial endotoxins. The bacterial endotoxin test uses the lysate from blood cells from horseshoe crabs to detect bacterial endotoxins. As the BET is an in vitro (performed outside of a living organism; not a destructive assay) assay, the three principles of Replace, Reduce, and Refine was a primary consideration when developing the test.

  • Where do I find more information?

    You may find more information on our Endosafe technical resources page.