_______________________________________________________________________________________________________________________________ The HaemoMAT® assay is an in vitro-assay for the verification of pyrogens as an authorized alternative method to the rabbit pyrogen test.

Test principle

The HaemoMAT® System is based on the stimulation of Peripheral Blood Mononuclear Cells (PBMC). The response of the PBMCs to pyrogenic substances is measured by determination of the amount of released Interleukin-6 (IL-6). IL-6 plays a key role in the immune response reaction of the PBMCs. To check the suitability of the test system, this kit provides bacterial endotoxin (lipopolysaccharide) as well as three different Non-Endotoxin Pyrogens (NEP) controls.

Assay time: 2 days Handling time Day 1: app. 2 hours Handling time Day 2: app. 3,5 hours

Specifications Numbers of samples 2 Samples (three dilutions) Non-Endotoxin Pyrogen Controls 3 IL-6 ELISA Control 1 Sample Volume 8 x 20 µl per sample dilution Endotoxin Standard Range 0,0625 EU/mL- 1 EU/mL Limit of Detection 0,125 EEU/mL (Endotoxin Equivalent Units)

Kit components and storage The MAT-kit consists of two packages that are provided separately under different shipping conditions.

HaemoMAT® Box 1: cool pack (2 – 8°C) HaemoMAT® Box 2: dry ice