Pyrogen test using human blood
Regulatory accepted 2002
European Union Reference Laboratory for Alternatives to Animal Testing, Ispra, Italy
The in vitro pyrogen test using human cryopreserved whole blood/IL-1 Beta (Cryo-WBT-IL1) is a monocyte activation test (MAT) used to detect or quantify substances that activate human monocytes or monocytic cells to release pro-inflammatory cytokines, for example, tumour necrosis factor-alpha (TNFα), interleukin-1 beta (IL-1β) and interleukin-6 (IL-6).
These cytokines have a role in fever pathogenesis. Consequently, the MAT can detect the presence of pyrogens in the test sample. The MAT is suitable, after a product-specific validation, as a replacement for the rabbit pyrogen test or the bacterial endotoxin test (Limulus amebocyte lysate assay). Validated and regulatory approved under TM2002-02 (EU) by EURL ECVAM (TSAR list).
In vitro pyrogen test using human cryopreserved whole blood/IL-1 beta (Cryo-WBT-IL1)
EURL ECVAM
Added on: 07-02-2020
[1] https://tsar.jrc.ec.europa.eu/test-method/tm2002-02
