COMPARISON OF LIMULUS AMEBOCYTE LYSATE (LAL) TEST WITH THE RABBIT PYROGEN TEST

家兔热原检查批次样品送中心 用于放行的生物制品评价和研究是首次使用 LAL测试 稀释度为 然后使用标准家兔热原试验检测1：32或更高 （标题CFR 600.13（B）（1）、（2）、（3））。 此外，还在 家兔热原试验的常规方式。 除了少数例外， 家兔热原试验和鲎试剂试验。 本研究将为使用LAL试验而不是 适当时，在产品质量控制中进行家兔热原试验。 该研究将继续进行，以收集更多的数据， 各种生物制品的鲎试剂和家兔热原试验。

Samples of lots subject to the rabbit pyrogen test submitted to the Center for Biologics Evaluation and Research for release are first testing using the LAL test. All samples with a positive lysate test at a dilution of 1:32 or greater are then tested using the standard rabbit pyrogen test (Title CFR 600.13(b)(1),(2),(3)). In addition, lots are selected in the usual fashion for the rabbit pyrogen test. With only few exceptions, there has been a positive correlation between the rabbit pyrogen test and the LAL test. This study will provide the basis for use of the LAL test instead of the rabbit pyrogen test in the quality control of products where appropriate. The study will be continued in order to gather further data comparing the LAL and rabbit pyrogen test in a wide variety of biological products.