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:
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
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