ATLA::Alternatives to Laboratory Animals

Volume 30, Supplement 2

Comparison and validation of novel pyrogen tests based on the human fever reaction

ATLA 30, Supplement 2, 49-51, 2002

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

University of Konstanz, Steinbeis-Technology Transfer Center for In Vitro Pharmacology and Toxicology (STZ InPuT), 78457 Konstanz, Germany

SUMMARY

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 prevaliclation study on the way to evaluation in a formal validation study.

Keywords: human fever reaction, in vitro pyrogen tests, LAL test, prevalidation, pyrogens, rabbit pyrogen test, validation