International validation of novel pyrogen tests based on human monocytoid cells

Hoffmann, Sebastian; Peterbauer, Anja; Schindler, Simone; Fennrich, Stefan; Poole, Stephen; Mistry, Yogesh; Montag-Lessing, Thomas; Spreitzer, Ingo; Löschner, Bettina; Aalderen, M. van; Bos, R.; Gommer, Martin; Nibbeling, Ria; Werner-Felmayer, Gabriele; Loitzl, Petra; Jungi, Thomas W.; Brcic, Marija; Brugger, Peter C.; Frey, Esther; Bowe, Gerard; Casado, Juan; Coecke, Sandra; Lange, Jan de; Mogster, Bente; Næss, Lisbeth Meyer; Aaberge, Ingeborg S.; Wendel, Albrecht; Hartung, Thomas

doi:10.1016/j.jim.2005.01.010

Cited by 158 publications

(121 citation statements)

References 23 publications

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“…Five variants of the MAt have been standardized, validated (Hoffmann et al, 2005), and accepted by the european Centre for the Validation of Alternative Methods (eCVAM) and the eC-VAM Scientific Advisory Committee (ESAC) as alternatives to the RPt for endotoxin pyrogen detection (eCVAM, 2006), and they proved to have a lower detection limit than the rabbit test. They are more accurate, cost-efficient, and more time-efficient.…”

Section: The Bacterial Endotoxin Test or Limulus Amebocyte Lysate Testmentioning

confidence: 99%

“…Because the validation study has already been published in detail (Hoffmann et al, 2005), we will focus here on the unpublished data concerning the performance of the tests towards non-endotoxin substances, which are listed in table 10.…”

Section: Non-endotoxin Substancesmentioning

confidence: 99%

“…the following chapter is adapted from "Human(e) Pyrogen Test: Final Report, QLRT-1999-00811, Quality of Life and Management of Living Resources, Comparison and Validation of Novel Pyrogen Tests Based on the Human Fever Reaction, Human(e) Pyrogen Test" (Hoffmann et al, 2005).…”

Section: Formal Ecvam Validation Studymentioning

confidence: 99%

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Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test

Hasiwa

Daneshian

Bruegger

et al. 2013

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Section: The Bacterial Endotoxin Test or Limulus Amebocyte Lysate Testmentioning

confidence: 99%

Section: Non-endotoxin Substancesmentioning

confidence: 99%

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Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test

Hasiwa

Daneshian

Bruegger

et al. 2013

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“…With respect to endotoxin, the IPT is less sensitive than the LAL (detection limit of 3 pg/ml) and slightly more sensitive than the rabbit test (Hoffmann et al, 2005). Binding of LPS to the albumin beads is probably mediated by hydrophobic interactions (Jurgens et al, 2002), suggesting that lipopeptides or glycolipids may bind as well.…”

Section: Discussionmentioning

confidence: 99%

“…It measures the release of the fever-mediator interleukin-Ijs (IL-I~) in human whole blood upon incubation with the sample substance (Hartung and Wendel, 1995). This test has been validated as a full alternative to the rabbit pyrogen assay in a collaborative EU-funded study (Schindler et al, 2001;Hoffmann et al, 2005).…”

Section: Introductionmentioning

confidence: 99%

In vitro pyrogen test for toxic or immunomodulatory drugs

Daneshian

Guenther

Wendel

et al. 2006

Journal of Immunological Methods

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Pyrogenic contaminations of some classes of injectable drugs, e.g , tox ic or immunomodulatory as well as false-positive drugs, represent a major risk which cannot yet be excluded due to the limitations of current tests . Here we describe a modification of the In vitro Pyrogen Test termed AWIPT (Adsorb, Wash, In vitro Pyrogen Test), which addresses this problem by introducing a preincubation step in which pyrogenic contaminations in the test sample are adsorbed to albumin-coated beads. After rinsing, the beads are incubated with human whole blood and the release of the endogenous pyrogen interleukin-I~is measured as a marker of pyrogenic activity. Intentional contaminations with lipopolysaccharide were retrieved from the chemotherapeutic agents paclitaxel, cisplatin and liposomal daunorubicin, the antibiotic gentamicin, the antifungal agent liposomal amphotericin B, and the cort icosteroid prednisolone at lower dilut ions than in the standard in vitro pyrogen test. This represents a promising new approach for the detection of pyrogenic contamination in drugs or in drugs containing interfering additives and should lead to improved safety levels .

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