Cooper J F
Prog Clin Biol Res. 1985;189:241-9.
Evaluation of medical devices and pharmaceutical products for endotoxin content is the most significant biomedical application of Limulus amebocyte lysate (LAL). This review summarizes the means by which LAL reagent suppliers have introduced different production techniques and formulation additives to uniquely optimize their products for industry. Pharmaceutical testing requires a LAL reagent that is buffered, stabilized to a sensitivity of 0.12 EU/ml, optimized to detect E. coli-derived LPS in water, formulated to produce firm opaque gels, designed specifically to detect bacterial endotoxin, and is economical. Unique LAL reagent characteristics produce nonuniformity in drug compatibility testing but does not significantly alter detection of unsafe levels of native endotoxin. Design of a clinical LAL reagent may require additional means for standardization and exclusion of additives which are only useful for pharmaceutical testing. A cooperative effort between clinical investigators and the LAL industry should resolve these issues in a reasonable period of time.
评估医疗设备和药品中的内毒素含量是鲎试剂（LAL）最重要的生物医学应用。本综述总结了LAL试剂供应商引入不同生产技术和配方添加剂的方式，以便为行业独特地优化其产品。药物检测需要一种缓冲的、稳定至0.12 EU/ml灵敏度的LAL试剂，该试剂经过优化以检测水中大肠杆菌衍生的LPS，配方能产生坚固不透明的凝胶，专门设计用于检测细菌内毒素，且经济实惠。独特的LAL试剂特性在药物相容性测试中会产生不一致性，但不会显著改变对天然内毒素不安全水平的检测。临床LAL试剂的设计可能需要额外的标准化手段和排除仅对药物检测有用的添加剂。临床研究人员和LAL行业之间的合作应能在合理时间内解决这些问题。
