Testing of parenteral pharmaceuticals and medical devices for pyrogens (fever-inducing substances) is critical to patient safety. The original rabbit pyrogen test has largely been replaced by different bacterial endotoxin tests based on Limulus amebocyte lysate (LAL), sourced from the blood equivalent of horseshoe crabs after comparative studies to the rabbit pyrogen test. Since 2004 a bacterial endotoxin test based on recombinant factor C (rFC), the endotoxin sensor protein inside of LAL, has been used as an animal-free alternative to LAL. Likewise, numerous studies compared LAL and rFC. Here we describe the history of pyrogen and bacterial endotoxin testing and summarize the evidence presented by those studies. We demonstrate that rFC and LAL are equivalent and comparable.

中文翻译：

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重组细菌内毒素检测：经过验证的解决方案。

胃肠外药物和医疗器械的热原（引起发热的物质）测试对于患者安全至关重要。最初的兔热原测试在很大程度上已被基于鲎变形细胞裂解物 (LAL)的不同细菌内毒素测试所取代，该测试来源于马蹄蟹的血液当量，经过与兔热原测试的比较研究。自 2004 年以来，基于重组因子 C (rFC) 的细菌内毒素测试，LAL 内的内毒素传感器蛋白，已被用作 LAL 的无动物替代品。同样，许多研究比较了 LAL 和 rFC。在这里，我们描述了热原和细菌内毒素检测的历史，并总结了这些研究提供的证据。我们证明 rFC 和 LAL 是等效和可比较的。