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

向中心提交的接受兔热原检测的批次样本 对于生物制品的评价和研究释放是第一次测试使用 拉尔测试。所有样品的裂解试验呈阳性，稀释 1：32或更大，然后使用标准的兔热原检测 (标题CFR 600.13(B)(1)、(2)、(3))。此外，地段是在 兔子热原检测的常规方式。 除了少数例外，两者之间存在正相关关系 兔热原试验和LAL试验。 这项研究将为使用LAL测试而不是 兔热原检测在产品质量控制方面适当。 这项研究将继续进行，以便收集更多数据，比较 在各种各样的生物制品中进行LAL和兔热原检测。

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.