Navigation path

Note: Fields marked with * are mandatory

Monocyte Activation Test

Topic : Quality control of vaccines, Airborne pyrogens

Test Method Number: TM2016-06 (BRA)
Short Name of TM: MAT
Submission received on: November, 2016
Responsible Organisation: BraCVAM - Brazil
Stage of Validation: Ongoing
Stage of Regulatory acceptance/Standards: Drafting of new regulatory standard/guideline

Method Description

MAT is intended to determine pyrogenic contamination of injectable products. The aim of this activity is to demonstrate new appplications of MAT, such as, its use on biological products (hyperimmune sera, vaccines, blood products), medical devices, nanomaterials and Non-Endotoxin Pyrogens (NEPs). Once demonstrated, this test may replace Rabbit Pyrogen Test (RPT) or enter together wit Bacterial Endotoxin Test (BET). In this last case, since BET is negative, it is needed to perform MAT. If BET is positive, then, stop.

The assay is based upon the Human mechanism of fever. The products is kept in contact with human blood and the cytokines (IL-1b and/or IL-6) are measured by commercial ELISA,

Track Approval Status

  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards
Step
 Submission 
In progressValidationShow status
 Peer-review 
 Recommendation 
In progressRegulatory acceptance/StandardsShow status
tutorial