accepted alternative. Its lack of mention in Pharmacopeias remained an issue, as there was no good standard for running the test in production. In 2016, it was added to the European Pharmacopoeia. A patent on rFC also limited adoption until its expiration in 2018. On 1 June 2020, the United States Pharmacopeia (USP) decided to cancel the proposal to include recombinant technology for endotoxin testing in chapter <85> Bacterial Endotoxins and start the development of a separate chapter that expands on the use, validation, and comparability of endotoxin tests based on recombinantly derived reagents. A separate guidance only chapter 1085.1 was proposed by the USP, though comments and feedback published on 11 December 2020 show that pharmaceutical companies and the FDA do not support this chapter, and request for compendial status. Monocyte Activation Test The monocyte activation test (MAT) is another proposed method to test for endotoxins based on monocytes in human blood. It measures the release of cytokines from these due to the presence of pyrogens, basically mirroring the process by which these toxins cause fever in humans (and rabbits, as in the original pyrogen test). A protocol for the MAT test, using cultured cells, is described in the European Pharmacopoeia. A recent study employing genetically engineered monocytes was able to significantly enhance the sensitivity of monocyte-based detection assays by bringing down the assay-completion time from more than 20 hours to 2–3 hours. See also Limulus clotting enzyme Lipopolysaccharide References External links horseshoecrab.org LAL Update Endotoxin Detection Product 1987 FDA LAL test guideline LAL Test Reagents Chemical tests