COMPARISON OF LAL TEST WITH THE RABBIT PYROGEN TEST

使用3种LAL试验方法（凝胶法、动态显色法和动态浊度法）中的一种对使用家兔热原试验进行放行检测的生产商产品批次进行检测。 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。 由于人力和财力资源有限，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.