FDA 许可的鲎试剂

最昂贵的鲎实验是无效导致必须重复进行的检测。细菌内毒素检测 (BET) 产生有效结果需要稳定的检测程序、维护良好的设备和经过适当培训的人员,但推动 BET 决策过程的往往是成本,而不是质量。

Charles River 开发并优化了一系列定量和定性鲎试剂配方,可提供更高的灵敏度、更高的线性度和出色的抗干扰性。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。

技术员手持鲎实验模块Endosafe® 模块技术:Endosafe® 模块技术是我们的高级解决方案,可满足客户对更高灵敏度和更快定量结果的需求。该模块技术旨在改进和完善我们对鲎试剂的使用,减少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变化。

实验室技术人员使用 BioTek® 培养酶标仪进行动态显色法鲎实验动态显色法鲎试剂:Endochrome-K™ 是一种完全定量且非常稳定的动态显色法试剂,包含增强 KCA 配方,可提供无与伦比的灵敏度、线性度和抗干扰性组合。Endochrome-K™ 可在大约一小时内提供定量内毒素值,具体取决于用户所需的灵敏度,并且重组鲎试剂非常稳定,可延长实验时间和重复使用,使其成为非常经济的解决方案。

密封瓶装动态浊度测定试剂动态浊度法鲎试剂:借助我们的动态浊度 (KTA) 试剂,您可以使用单个 FDA 许可产品改进检测,该产品可以进行动态和凝胶分析,并且反应时间更短,无需预培养。我们的第二代试剂 KTA2 具备业内最快的浊度法鲎试剂反应时间,增强配方可提供无与伦比的灵敏度、线性度和抗干扰性组合,并且检测时间最短。

技术人员进行凝胶鲎试剂测定凝胶鲎试剂:凝胶鲎试剂测定是低容量实验室基本定性检测的最佳选择。我们的裂解液可在很宽的灵敏度范围形成牢固凝胶,这是因为缓冲试剂可为常规鲎实验提供更好的抗干扰性。

除了试剂,我们还提供一系列鲎试剂附件。选择鲎实验检测附件是内毒素检测不可或缺的一部分,这些附件有助于采集没有人工因素和干扰源影响的数据。选择 BET 的非干扰附件不仅是药典指令,也是监管部门的期望。 

索取报价 / 信息

Endosafe® 客户门户网站

实验室分析师对鲎试剂进行质控检查轻松访问并下载 Endosafe® 分析证书、材料安全数据表、包装说明书和保修表格。立即登录

Frequently Asked Questions (FAQs) About LAL Assays and LAL Reagents

  • How does the LAL test work?

    The bacterial endotoxin test uses Limulus amoebocyte lysate (LAL), which is an aqueous extract derived from horseshoe crab blood. The LAL will either become opaque, or in the case of kinetic chromogenic lysate, yellow, in the presence of endotoxin. Endotoxin is a fever-producing byproduct of Gram-negative bacteria.

  • What is the LAL test used for?

    The LAl test is used to detect and measure instances of bacterial endotoxin contamination in drugs, biological products, medical devices, and others. The LAL test is the most sensitive and specific means to detect bacterial endotoxin.

  • When should an LAL test be performed?

    The LAL test should be performed on raw materials and final products for intravenous intrathecal drug products, in addition to medical devices. Performing an LAL test provides data on potentially contaminated products, in which the contaminants would directly enter the bloodstream of the person to which it is administered. Bacterial endotoxins cause a pyrogenic reaction that can be deadly in many cases.

  • What is LAL reagent water?

    LAL reagent water is water that is endotoxin-free, which is mainly used in the BET to reconstitute LAL and controlled standard endotoxin (CSE), and to make sample dilutions.

  • Which is the best LAL test for endotoxin testing?

    The gel-clot LAL test is very sensitive and accurate, however it is a time-consuming process as each assay takes 30-40 minutes of an analyst's time. And as there is no automation for this method, there is potential for bias or human error when the technician reads and interprets the test results.

    The chromogenic LAL test is user-friendly and can be automated, which decreases the amount of time required to perform the test, allows more tests to be completed per unit of time, and calculations can be performed simply. Kinetic turbidimetric and chromogenic LAL tests both give a quantitative result. They require, however, more technician time and preparation, resulting in room for human error.

    Endosafe® cartridges eliminate the need for a standard curve, reducing the amount of time to result and decreasing the chance for human error. Each lab needs to decide for themselves which LAL test works best for them based on throughput, human capital, money and time resources, data integrity strategy, and sustainability practices.

    Learn more about Charles River's complete portfolio of FDA-licensed reagents and accessories to aid and ensure bacterial endotoxin-free products during manufacturing.

  • What are the methods for bacterial endotoxin testing (BET)?

    The main methods used for bacterial endotoxin testing use Limulus Amoebocyte Lysate (LAL) and are gel-clot, kinetic chromogenic, and kinetic turbidimetric. The gel-clot method is a qualitative BET and is used to detect the presence or absence of endotoxin in the prepared sample. When endotoxin encounters the LAL reagent, it triggers a series of enzymatic reactions. The enzymes change the amoebocyte coagulogen present in LAL reagent to form a detectable gel-clot.

    After the test is performed, if a clot has formed and remains intact at the bottom of the tube, the result of the test is positive, meaning that there is detectable endotoxin in the sample. When no clot forms or the clot dissipates when the tube is turned upside down, the result is negative, meaning there is no detectable endotoxin in the sample based on the sensitivity of the LAL reagent.

    The kinetic chromogenic method measures the absorbance of light in LAL reagent to determine if endotoxin is present by visible color changes. The degree of color and the rate at which the color appears is directly proportional to the amount of endotoxin within the sample.

    The chromogenic method is user-friendly and can be automated, which decreases the amount of time required to perform the test, allows more LAL assays to be completed per unit of time and calculations can be performed simply. Charles River Endosafe® cartridge technology uses the chromogenic method.

    The kinetic turbidimetric method is a modified extension of the gel-clot test. It measures the change in turbidity over time. The LAL reagent is altered so it is unable to form a solid clot when exposed to endotoxin. The amount of endotoxin present is inversely proportional to the reaction time.

    Learn more about Charles River's complete portfolio of FDA-licensed reagents and accessories to aid and ensure bacterial endotoxin-free products during manufacturing.

  • Does Charles River offer FDA-licensed bacterial endotoxin testing (BET) reagents and accessories?

    Charles River offers a complete portfolio of FDA- licensed reagents and accessories to aid and ensure bacterial endotoxin-free products during manufacturing.

  • Where do I find more information?

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