Bacterial Endotoxin Testing

The Bacterial Endotoxins Test (BET), also known as the Limulus Amebocyte Lysate (LAL) test, is a microbiological assay used to detect and quantify endotoxins — toxic components of the outer membrane of Gram-negative bacteria — in pharmaceutical products, medical devices, and biologicals. Endotoxins can cause severe inflammatory responses if introduced into the body, so their levels must be strictly controlled.

The ability to detect all environmental Gram-negative bacterial endotoxins is a critical element of safe parenteral production and implantable medical device manufacturing. With over 80 million endotoxin tests performed annually, these medical techniques, treatments, and therapies sustain the lives of thousands of patients, requiring a highly sensitive and exquisitely specific in vitro assays to ensure their quality and safety for release.