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

接受家兔热原试验的批次样品提交给 生物制品评价和研究中心首次发布 使用LAL测试进行测试。所有样品的阳性裂解物测试在 然后使用标准兔测试1：32或更高的稀释度 热原试验（CFR第600.13（B）（1）、（2）、（3）条）。此外，地段 以常规方式选择用于家兔热原试验。 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 家兔热原试验在产品质量控制中的应用 适当 这项研究将继续进行，以收集更多的数据， 鲎试剂和家兔热原试验在各种生物制品中 产品.

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. This study will be continued in order to gather further data comparing the LAL and rabbit pyrogen test in a wide variety of biological products.