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

Submission

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Date	Stage	Comment	Documents/Links
Jan 2000	Not applicable

Validation

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Date	Stage	Comment	Documents/Links
Jan 2000	Finalised	The results of the validation study are reported in Hoffmann et al. International Validation of Novel Pyrogen Tests Based on Human Monocytoid Cells. Journal of Immunological Methods 2005, 298; 161-173. DOI:10.1016/j.jim.2005.01.010

Peer-review

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Date	Stage	Comment	Documents/Links
May 2005	Ongoing	The ESAC peer-reviewed five in vitro pyrogenicity tests (also named monocyte activation test, MAT) during 2005-2006 including the In Vitro Pyrogen Test using Human Whole Blood/IL-1 Beta.
Mar 2006	Finalised	The ESAC statement confirms the scientific validity of five in vitro pyrogenicity tests, including the In Vitro Pyrogen Test using Human Whole Blood/IL-1 Beta, subject to product specific validation.	ESAC statement

Recommendation

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Date	Stage	Comment	Documents/Links
Mar 2009	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Mar 2009	Adopted/published	The European Pharmacopoeia General Method 2.6.30 Monocyte-activation test was adopted by the European Pharmacopoeia Commission in March 2009 and came into force in September 2009. The In Vitro Pyrogen Test using Human Whole Blood/IL-1 Beta is covered by this text. The MAT is suitable, after product-specific validation, as a replacement for the rabbit pyrogen test or the bacterial endotoxin test.