COMPARISON OF LAL TEST WITH THE RABBIT PYROGEN TEST

使用兔热原释放测试的制造商产品批次使用三(3)种LAL测试方法（凝胶凝块，动态显色和动态浊度法）中的一种进行测试。具有最小抑制或增强作用的LAL试验是该产品的既定试验。测试产品的LAL测试结果必须证明其内毒素浓度低于FDA指南中关于将鲎试剂裂解液测试作为人类和动物亲本药物、生物制品和医疗器械的最终产品测试的验证的内毒素限值。建议用LAL法代替兔热原法检测该产品的内毒素。LAL检测灵敏度更高，需要的样品更少，可以在1小时内完成，而且比兔检测便宜得多。由于人员和财政资源有限，今年没有进行额外的实验室研究。

Manufacturers' product lots tested using the Rabbit Pyrogen test 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. Because of limited personnel and finacial resources no additional laboratory studies were performed this year.