Mat Test For Pyrogens

Nowadays the most used tests are the rabbit pyrogen test rpt and or the bacterial endotoxin test bet.

Mat test for pyrogens.

The monocyte activation test mat can detect both endotoxin and non endotoxin pyrogens in one test. Agents pyrogens were identified in 1912 by hort and penfold who were also the first to design a pyrogen test based on injection of material into rabbits. In vitro test lal test 2. 6 the detection of relevant or unusual endotoxin levels in a sample is a sign of danger but presence or absence of endotoxin can t be directly converted into pyrogenicity absence of pyrogenicity.

In recent years an alternative in vitro pyrogen test the monocyte activation test mat has been developed to detect and quantify endotoxin and nep contaminations. According to the regulations to ensure quality control of parenteral drugs the suitability of the mat must be demonstrated in a product specific validation. The depth of insertion is constant for any one rabbit in any one test. 5 the nonspecific nature of the mat makes it superior to the bet in the assessment of multiple innate immune response modifiers.

It was found that all hsa batches were contaminated with 1 3 beta glucans which interfere with the conventional lal. Interestingly it was shown that live. Recording of temperature thermometer or thermistor insert the thermometer or temperature sensing probe into the rectum of the test rabbit to a depth of about 5 cm. The pyrogen test is designed to limit the risk of febrile reaction following parentral administration of drugs.

Consequently the mat is intended to detect the presence of pyrogens in the test sample and include peptidoglycans lipoteichoic acids synthetic bacterial lipoproteins and flagellin. The mat is an unspecific test detecting various pathogen associated molecular patterns by several receptors. The assay is based on the human immune response by measuring cytokine production of human peripheral blood mononuclear cells pbmc. It includes both in vitro and in vivo tests.

The pyrogen test aims to prove that the concentration of pyrogens contained in the product does not exceed a certain threshold known as the contaminant limit concentration clc that will preserve patient safety. At that time the pyrogenic agent was identified as endotoxins included in preparations of gram negative bacteria. To the rabbit inject intravenously 10 ml of pyrogen free saline solution. Mat was pointed to as the compendial method of pyrogen detection in the european pharmacopoeia chapter 2 6 30 and since the 2016 revision recommendations have been given to replace tests on rabbits with the mat wherever possible and after product specific validation ep 2 6 8 rev.

Testing for pyrogens is a critical step in ensuring the safety of parenteral pharmaceutical products and medical devices.