Evaluation of Recombinant Cascade Reagent PyroSmart NextGen<sup>®</sup> and Limulus Amebocyte Lysate Equivalency in a Plate and Tube Reader for Bacterial Endotoxins Testing

PyroSmart NextGen® is a recombinant cascade reagent (rCR) for the detection and quantification of bacterial endotoxins developed using cloned genes derived from Limulus polyphemus horseshoe crab genome. Requirements use this alternative include analysis analytical performance, method suitability, test result equivalency to amoebocyte lysate (LAL) reagents used in compendial Bacterial Endotoxins Test (BET). The plate reader evaluation has been expanded address two long-standing user preferences, with inclusion tube increasing sensitivity endotoxin 0.005 EU/mL 0.001 EU/mL. utilization different instrument types also allows more comprehensive analysis. Furthermore, comparison results demonstrate that detects equivalent levels autochthonous water samples when compared LAL reagents. Overall, study provides first large-scale example utilizing robust rCR verified meets expectations