COMPARISON OF LAL TEST WITH THE RABBIT PYROGEN TEST

LAL 测试与兔子热原测试的比较

• 批准号: 2569073
• 负责人: H D HOCHSTEIN
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2569073
• 关键词: bioassay; biological products; chemical standardization; drug quality /standard; endotoxins; horseshoe crabs; laboratory rabbit; phagocytes; pyrogens

Samples of lots subject to the rabbit pyrogen test submitted to the Center for Biologics Evaluation and Research for release are first tested using one of the three (3) LAL test methods. The test with the least inhibition or enhancement is the established test for that product. The manufacture is then notified of our results and it is recommended that the LAL method is the test of choice for detecting endotoxin that product instead of the rabbit pyrogen test. The LAL test is more sensitive, requires less sample, can be completed in less than 1 hour, and is much less expensive than the rabbit 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首次测试发布 使用三(3)种LAL测试方法之一。用最少的测试 抑制或增强是对该产品的既定测试。这个 然后将我们的结果通知制造商，并建议 LAL法是检测该产品内毒素的首选试验 而不是兔子热原检测。拉尔测试更敏感， 需要的样品少，不到1小时就能完成，而且 比兔子测试便宜。