The most expensive LAL test is the one that must be repeated because of invalidity. The generation of valid results for bacterial endotoxins testing (BET) necessitates robust test procedures, well-maintained equipment, and properly trained personnel, but too often it is cost, not quality, that is the driving force in the BET decision-making process. Charles River has developed and optimized a range of quantitative and qualitative LAL formulations that provides increased sensitivity, greater linearity, and superior interference resistance. Our LAL reagents are licensed by the FDA for product release, and all of our accessory products are certified for the appropriate LAL testing requirements. These deliver extreme precision and reliability, minimizing invalid results and the need to retest.
Prior to FDA approval of LAL in the 1980s, the rabbit pyrogen test was the standard FDA-approved test for endotoxins. This test, however, was labor intensive, lengthy, and expensive. Years of research and application have proven LAL to be unequivocally recognized as the most sensitive method available for the detection of endotoxins.
We offer a complete portfolio of LAL testing reagents and technologies, including our innovative cartridge-based testing systems, to help ensure safety in the manufacturing processes. Our FDA-licensed kinetic chromogenic and turbidimetric reagents yield quantitative endotoxin values and feature buffered formulations that provide robust testing with the highest accuracy and precision.