Current bacterial endotoxin testing systems can be labor-intensive and time-consuming, involving several manual pipetting steps. In our quality control laboratory, annually, we test about 15,000 samples of different grades of purified water, WFI and water samples taken to validate cleaning procedures for endotoxins. We are currently using the Kinetic-QCL™ assay which is a pharmacopeia method that provides reliable results. We compared this assay with another Limulus amebocyte lysate (LAL)-based assay (Endosafe®-MCS) and an alternative endpoint fluorescent recombinant Factor C (rFC) assay (ENDOZYME II GO®). Both these assays have been developed to reduce analyst preparation time. Our objective was to assess if they could increase the throughput of our testing while maintaining low rates of invalid results. The results demonstrated that the two most appropriate methods for rapid endotoxin detection in water are our current assay, K-QCL, and the rFC-based assay, ENDOZYME II GO. This latter assay was found to be less sensitive to interference than our current assay, particularly in cleaning validation water samples. It also showed better performance, accuracy, repeatability and had a shorter time-to-results. ENDOZYME II GO assay allows quick testing of large numbers of samples with reliable results and is a good alternative for conventional LAL assays.

当前的细菌内毒素检测系统可能是劳动密集型且耗时的，涉及多个手动移液步骤。在我们的质量控制实验室，我们每年测试大约 15,000 个不同等级的纯净水样品、WFI 和用于验证内毒素清洁程序的水样。我们目前正在使用 Kinetic-QCL™ 测定法，这是一种药典方法，可提供可靠的结果。我们将此测定与另一种鲎进行了比较基于变形细胞裂解物 (LAL) 的测定 (Endosafe®-MCS) 和替代终点荧光重组因子 C (rFC) 测定 (ENDOZYME II GO®)。开发这两种检测方法是为了减少分析人员的准备时间。我们的目标是评估它们是否可以提高我们测试的吞吐量，同时保持低无效结果率。结果表明，在水中快速检测内毒素的两种最合适的方法是我们目前的检测方法 K-QCL 和基于 rFC 的检测方法 ENDOZYME II GO。发现后一种测定对干扰的敏感性低于我们目前的测定，特别是在清洁验证水样方面。它还表现出更好的性能、准确性、可重复性，并且获得结果的时间更短。