COMPARISON OF LAL TEST WITH THE RABBIT PYROGEN TEST

由于购买动物的资金短缺，今年只进行了几次兔子热原检测。由制造商使用提交给生物制品评估和研究中心进行放行的兔热原检测的批次使用三(3)种LAL检测方法(凝胶凝块法、动力学发色法和动力学比浊法)之一进行检测。抑制或增强最小的LAL试验是该产品的既定试验。测试产品的LAL检测结果必须证明其内毒素浓度低于FDA关于对人和动物父母用药物、生物制品和医疗器械进行终产品检测的凝胶溶解试验确认指南中规定的内毒素限度。建议用LAL法代替兔热原检查法检测该产品中的内毒素。LAL试验更灵敏，需要的样本更少，不到1小时就能完成，而且比兔子试验便宜得多。

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.