COMPARISON OF LAL TEST WITH THE RABBIT PYROGEN TEST

LAL 测试与兔子热原测试的比较

• 批准号: 6161380
• 负责人: TROY QUANDER
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6161380
• 关键词: bioassay; biological products; chemical standardization; drug quality /standard; endotoxins; horseshoe crabs; laboratory rabbit; phagocytes; pyrogens

Due to funding shortfalls for animal purchases only a couple of Rabbit Pyrogen tests were performed this year. Lots tested by the manufacturer using the Rabbit Pyrogen test submitted to the Center for Biologics Evaluation and Research for release are tested using one of the three (3) LAL test methods (Gel Clot, Kinetic Chromogenic, and Kinetic Turbidimetric). The LAL test with the least inhibition or enhancement is the established test for that product. The LAL test results for the test product must demonstrate an endotoxin concentration lower than the endotoxin limit established in the FDA Guideline On Validation Of The Limulus Amebocyte Lysate Test As An Endproduct Test For Human and Animal Parental Drugs, Biological Products, And Medical Devices. It is recommended that the LAL method is the test of choice for detecting endotoxin in that product instead of the Rabbit Pyrogen test. The LAL test is more sensitive, requires less sample, can be completed in less than 1 hour, and is much less expensive than the rabbit test.

由于动物采购资金短缺，今年仅进行了几项家兔热原试验。 使用三种LAL检测方法（凝胶法、动态显色法和动态浊度法）之一来检测生产商使用提交给生物制品评价和研究中心用于放行的家兔热原试验检测的批次。 具有最小抑制或增强作用的LAL试验是该产品的既定试验。 供试品的LAL试验结果必须证明内毒素浓度低于FDA关于鲎变形细胞溶解物试验作为人和动物亲代药物、生物制品和医疗器械最终产品试验的确认指南中确立的内毒素限值。 建议选择LAL方法代替家兔热原试验检测产品中的内毒素。 LAL测试更敏感，需要更少的样品，可以在不到1小时内完成，并且比兔子测试便宜得多。