Comparison of LAL Test with the Rabbit Pyrogen Test

摘要：热原或内毒素含量的测定可以通过21 CFR 610.13中描述的兔热原试验来测量，或者，如果验证为等效方法，可以使用USP 23细菌内毒素试验中描述的鲎试剂（LAL）测定。许多生物制品的允许内毒素含量可在“FDA关于将鲎试剂裂解液试验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试验的验证指南”中找到；或者，产品或制造商特定的限制与许可一起确定。显色法、浊度法和凝胶凝块法是商业化的体外LAL检测方法；在没有增强或抑制作用的情况下，凝胶凝块法被认为是确定的。一般来说，LAL方法比Rabbit方法的优点包括需要较少的样品和能够快速轻松地进行重复测试。今年，两家制造商已经能够提供单个产品的足够数据，以LAL测试方法取代兔子测试。

Summary: Determination of pyrogen or endotoxin content may be measured by the Rabbit Pyrogen test as described in 21 CFR 610.13 or, if validated as an equivalent method, use of the Limulus Amebocyte Lysate (LAL) assay as described in the USP 23 Bacterial Endotoxins Test. Allowable endotoxin content for a number biological products can be found 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"; alternatively, product or manufacturer specific limits are established in conjunction with licensing. Chromogenic, Turbidimetric and gel clot methods fo the in-vitro LAL test are commercially; the gel clot method is considered definitive in the absence of enhancement or inhibition. In general, advantages of LAL methods over the Rabbit test include requiring less sample and the ability to perform repeat tests quickly and easily. This year, tow manufacturers have been able to provide sufficient data on individual products to replace the rabbit test with a LAL test method. Work is continuing to expand LAL testing to additional blood products and vaccines. Examination of possible cross contamination of glucans introduced during processing that react with the lysate also is continuing. We hope to continue research in this area in conjunction with other Center Offices.