Comparison and Validation of Novel Pyrogen Tests Based on the Human Fever Reaction

Thomas Hartung and Members of the Human(e) Pyrogen Test Study Group

The Limulus amoebocyte lysate (LAL) test has replaced about 80% of the use of the rabbit pyrogen test. Ideally, human-based in vitro tests are needed, to replace the remaining use of the rabbit test and the use of the LAL test. The progress of an EU-funded project is described, in which a number of in vitro tests based on the human fever reaction are passing through a prevalidation study on the way to evaluation in a formal validation study.