Monocyte activation test

Commonly used acronym: MAT

Scope of the method

Alternative method relates to
  • Human health
Alternative method is situated in
  • Regulatory use - Routine production
Type of alternative method
  • In vitro - Ex vivo
This method makes use of
  • Human derived cells / tissues / organs
Specify the type of cells/tissues/organs
Whole human blood cells

Description

Method keywords
  • Pyrogen test
  • alternative to rabbit pyrogen test
  • european pharmacopoeia
  • endotoxins and non-endotoxin pyrogens
Scientific area keywords
  • quality control of injectable medicines
Method description

The monocyte-activation test (MAT) is used to detect or quantify substances that activate human monocytes or monocytic cells to release endogenous mediators such as 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 will detect the presence of pyrogens (endotoxins on non-endotoxin pyrogens) in the test sample. The MAT is suitable, after a product-specific validation, as a replacement for the rabbit pyrogen test (see European pharmacopoeia chapter 2.6.30). Although 3 methods (quantitative test, semi-quantitative test or reference lot comparison test) are described in the Ph. Eur.

Lab equipment
  • Biosafety cabinet
  • CO2-incubator
  • ELISA plate reader
Method status
  • Still in development
  • History of use

Pros, cons & Future potential

Advantages
  • No rabbits
  • ex-vivo test
Challenges

Proper storage of whole human blood (store only in nitrogen tank, not at minus 80°C)

References, associated documents and other information

References
  • User Manual of the PyroDetect System Monocyte-Activation Test (MAT) from Merck
  • Monocyte Activation Test guideline from European Pharmacopoeia
Associated documents

Contact person

Celine Vanhee

Organisations

Sciensano
Chemical and physical health risks
Medicines and health products
Belgium