Bacterial Endotoxins Test (BET)

Endotoxin testing, or a bacterial endotoxin test (BET), such as LAL (limulus amebocyte lysate), is an in vitro assay used to detect bacterial endotoxins. The BET uses the lysate in blood cells from horseshoe crabs to detect bacterial endotoxins, thus warning quality control microbiologists of possible bacterial endotoxin contamination in their samples. Limulus amebocyte lysate (LAL) has proven to be recognized as the most sensitive and specific method available for the detection of endotoxins. With more than 70 million endotoxin tests performed annually for injectable pharmaceutical products and implantable medical devices, there has never been a single FDA-confirmed pyrogenic outbreak due to a false-negative LAL result.

Charles River uses LAL for all of our bacterial endotoxin test systems, reagents, and proprietary cartridge technology. As the most sensitive and robust assay available. We have transformed a qualitative bacterial endotoxin test gel-clot assay to a 15-minute quantitative bacterial endotoxin test assay available right on the production floor. Charles River has been at the forefront in the evolution of endotoxin testing, investing in the development of new technologies and innovative products to improve the quality of the endotoxin test and accelerate the development process. Charles River has purposely built portfolio of FDA-licensed products for rapid and traditional bacterial endotoxin testing to reduce retest rates and improve turnaround times so you can make prompt, confident decisions about the safety of your products.