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

接受兔热原检测的批次样本提交给 生物制品评估和研究中心发布为第一 使用LAL测试进行测试。所有裂解产物检测呈阳性的样本 然后用1：32或更大的稀释度用标准兔进行测试 热原检查(标题CFR 600.13(B)(1)、(2)、(3))。此外，地段是 以通常的方式被选来进行兔子热原测试。 除了少数例外，两者之间存在正相关关系 兔热原试验和拉尔试验。 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中的作用 恰如其分。 这项研究将继续进行，以便收集进一步的数据对比 LAL和兔热原检测在多种生物中的应用 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.