Monocyte Activation Testing (MAT) Medical Devices

THIS PAGE COVERS:

Why MAT could be the solution for pyrogen testing your medical device
How the method for Monocyte Activation Testing a medical device works
What regulatory bodies have to say about MAT testing medical devices

MAT the most comprehensive assay for testing medical devices

Testing medical devices for all pyrogens is a must

Medical devices manufactured for implantation into humans must be free of pyrogens. Pyrogenic contaminants on the surface of medical devices are very often not soluble.

BET and RPT test only rinsing solutions of products

BET and RPT fail to detect non-soluble pyrogens as these assays test only the rinsing solutions of products. These don't reflect the entire surface contamination which cause false negative results.

MAT captures all contaminations by direct incubation

Only the MAT tests medical devices by direct incubation with human blood cells which captures contaminants on a device's entire surface – making it the most comprehensive pyrogen test out there.

How would testing your medical device using MAT work?

MAT employs peripheral blood mononuclear cells to simulate the first stages of a human's immunological response to a medical device's contamination of pyrogens.

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Direct incubation of device

Your parenteral medical device is (where necessary, dynamically) incubated with peripheral blood mononuclear cells.

Immunological activation

Left overnight, Toll-like receptors of monocytes detect any pyrogens which will then launch the human immune system. The release of cytokines is activated.

Cytokine detection

The next morning, detection and quantification of released IL-6 cytokine concentration is established by carrying-out a human IL-6 ELISA,

Analysis of data

Concentration of cytokines in the medical device preparation is then converted into Endotoxin Equivalent units/ml using the LPS standard curve.

Regulatory bodies on suitability of MAT as a pyrogen test for medical devices

The European Pharmacopoeia (Ph. Eur.)

Ph. Eur. 2.6.8 Pyrogens: Recommendations to use MAT (2.6.30) as a replacement to Rabbit Pyrogen Test wherever possible.
Ph. Eur. 2.6.30 Monocyte Activation Test: "The monocyte Activation Test (MAT) is primarily intended to be used as a replacement for the Rabbit Pyrogen Test."
Ph. Eur. 5.1.10: "The Monocyte Activation Test (2.6.30) is a suitable method to use to rule out the presence of non-endotoxin pyrogens in substances or products"

The US Food and Drug Association (FDA)

In 2009, noted that the Monocyte Activation Test (MAT) may be used for parenteral products once product-specific validation (PSV) has been carried-out.

See Dr Norris Alderson's response (FDA Associate Commissioner for Science)

2012's Guidance for industry pyrogen and endotoxins testing allows MAT to be employed as LAL replacement for medical devices using PSV.

See Guidance for industry pyrogen and endotoxins: Questions and answers (2012)

The United States Pharmacopeia (USP)

Where appropriate, USP's "Pyrogens" General Chapter <151> permits the employment of a “validated, equivalent in vitro pyrogen or bacterial endotoxin test”.

The International Organization for Standardization (ISO)

ISO 10993-1:2018 explicitly expresses their preference for in-vitro rather than in-vivo models whenever they have been found to deliver information of equivalent relevance.
Further info. on ISO's stance on pyrogen testing is detailed in ISO 10993-11:2017.

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