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Medizinprodukte Prüfungen >> Unser Angebot >> Quantitative determination of PMN-Elastase
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Quantitative determination of PMN-Elastase - in vitro ELISA-Assay

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This assay determines the influence of a test material on the activation of leucocytes in human whole blood.

Polymorphonuclear (PMN) granulocytes play an important role as primary defence cells in inflammatory reaction. Different bloodstream mediators (cytokines, leukotrienes, complement factors, bacterial endotoxins, clotting and fibrinolysis factors) attract and stimulate these cells to phagocytize and destroy not naturally occurring agents.

PMN granulocytes use proteinases to digest these agents and tissue debris. One of these proteinases is PMN elastase which is localised in the azurophilic granules of the polymorphonuclear granulocytes and partially excreted into the extracellular surrounding during phagocytosis of foreign substances1. Primarily, the determination of PMN elastase finds its application in monitoring the course of trauma, shock and sepsis. Further applications include haemodialysis, infections by obstetrics, joint diseases, effusions of sport injuries, intestinal affection, pancreatitis, cystic fibrosis and male adnex affections.

The determination of the amount of PMN Elastase released into plasma following activation from interaction of a material or device with blood can indicate the extent of leukocyte activation.

The PMN-Elastase tests are performed in accordance with the ISO guidelines 10993-16, 10993-47 and 10993-128 at Eurofins BioPharma Product Testing Munich GmbH.

 

Procedure

Human whole blood samples are incubated with the test item. After Incubation the Plasma is gained from the blood samples and used to determine complement component concentration using an ELISA based method.

 

Historical Data

Historical data were generated from 2018 to 2021.

 

References

  1. Jochum M., Machleidt, W., Neuhof, H., and Fritz, H. Proteinases. In: Schlag G, Redl H (eds), Pathophysiology of Shock, Sepsis, and Organ Failure. Springer-Verlag Berlin Heidelberg, 1993: 46-60.
  2. ISO 10993-1: “Evaluation and testing within a risk management process”
  3. ISO 10993-4: “Selection of tests for interactions with blood”
  4. ISO 10993-12: “Sample preparation and reference materials”