Evidence for the Detection of Non-Endotoxin Pyrogens by the Whole Blood Monocyte Activation Test1
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169 t4 Report* Evidence for the Detection of Non-Endotoxin Pyrogens by the Whole Blood Monocyte Activation Test1 Nina Hasiwa 1,2, Mardas Daneshian 1, Peter Bruegger 4, Stefan Fennrich 5, Astrid Hochadel 2, Sebastian Hoffmann 6, Felix E. Rivera-Mariani 3, Christoph Rockel 7, Stefanie Schindler 8, Ingo Spreitzer 9, Sandra Stoppelkamp 5, Kranthi Vysyaraju 3, and Thomas Hartung 1,3 CAAt-europe, University of Konstanz, Konstanz, Germany; Atax-Advice, Konstanz, Germany; Johns Hopkins University, Bloomberg School of Public Health, CAAt, Baltimore, USA; Novartis, Basel, Switzerland; Department of thoracic, Cardiac and Vascular Surgery, tübingen University Hospital, tübingen, Germany; seh consulting + services, Paderborn, Germany; enzler Hygiene AG, Center for Hygiene, Pratteln, Switzerland; Animalfree Research, Zürich, Switzerland; Paul-ehrlich Institut (PeI), langen, Germany
منابع مشابه
Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test.
Threats of pyrogenicity were discovered more than a century ago. Measures to determine the safety of parenterals and, more recently, medical devices and cell therapies for human use have been in place for 70 years. Currently, there are three testing possibilities available: the Rabbit Pyrogen Test, the Limulus Amebocyte Lysate test (Bacterial Endotoxin Test), and test systems using human whole ...
متن کاملSystematic Review of Membrane Components of Gram-Positive Bacteria Responsible as Pyrogens for Inducing Human Monocyte/Macrophage Cytokine Release
Fifty years after the elucidation of lipopolysaccharides (LPS, endotoxin) as the principal structure of Gram-negative bacteria activating the human immune system, its Gram-positive counterpart is still under debate. Pyrogen tests based on the human monocyte activation have been validated for LPS detection as an alternative to the rabbit test and, increasingly, the limulus amebocyte lysate test....
متن کاملLeukoreduction system chambers provide a valuable source of functional monocytes for the monocyte activation test by comparison with internationally validated methods.
Despite being added to the European Pharmacopoeia in 2010 and strongly supported by the European directive enforcing the "3R's" - Replace, Reduce and Refine, uptake of the monocyte activation test (MAT) in preference over the rabbit pyrogen test for the detection of pyrogens has been limited. This has been attributed to the difficulty in sourcing human monocytes due to the necessity of phleboto...
متن کاملMonocyte activation test (MAT) reliably detects pyrogens in parenteral formulations of human serum albumin.
Disadvantages of the regulatory pyrogen test to assure safety of the end-product Human Serum Albumin (HSA) for parenteral use call for the implementation of an alternative test. In the current study, 16 HSA batches were assayed for pyrogens in parallel with the Rabbit Pyrogen Test, conventional and endotoxin-specific LAL assay and monocyte activation test (MAT). It was found that all HSA batche...
متن کاملDevelopment, validation and applications of the monocyte activation test for pyrogens based on human whole blood.
Microorganisms such as Gram-negative or Gram-positive bacteria, viruses and fungi contain components that activate the innate immune system. These components, called pyrogens (Greek: pyros=fire), can occur independently of viable microorganisms and are a major safety concern in parenterally administered drugs, since they can cause severe reactions such as fever, organ failure, and shock in the ...
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تاریخ انتشار 2015