Note: Fields marked with * are mandatory

In Vitro Pyrogen Test using Human Whole Blood/IL-1 Beta

Topic : Pyrogenicity

Test Method Number: TM2002-01 (EU)
Short Name of TM: WBT-IL1
Year received: 2002
Responsible Organisation: EURL ECVAM - European Union '
Protocol(s)/SOP(s): 133
General Comments:

Method Description

The In Vitro Pyrogen Test using Human Whole Blood/IL-1 Beta (WBT-IL1) is a monocyte activation test (MAT) applied 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 play 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 of the rabbit pyrogen test or the bacterial endotoxin test (Limulus amebocyte lysate assay).

Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
StepExpand All
 SubmissionShow status
 ValidationShow status
 Peer-reviewShow status
 RecommendationShow status
 Regulatory acceptance/StandardsShow status