COMPARISON OF LAL TEST WITH THE RABBIT PYROGEN TEST

使用兔热原放行测试进行测试的制造商产品批次是使用三 (3) 种 LAL 测试方法（凝胶凝块、动态显色和动态浊度）之一进行测试。 具有最小抑制或增强作用的 LAL 测试是该产品的既定测试。 测试产品的 LAL 测试结果必须证明内毒素浓度低于 FDA 鲎变形细胞裂解物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验证指南中规定的内毒素限值。 建议选择鲎试剂法来检测该产品中的内毒素，而不是兔热原测试。 LAL测试更灵敏，需要的样品更少，可以在不到1小时内完成，并且比兔子测试便宜得多。 由于人员和财力有限，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.