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dc.contributor.authorSCHINDLER Stefanieen_GB
dc.contributor.authorSPREITZER Ingoen_GB
dc.contributor.authorLOESCHNER Bettinaen_GB
dc.contributor.authorHOFFMANN SEBASTIANen_GB
dc.contributor.authorHENNES Kilianen_GB
dc.contributor.authorHALDER MARIAen_GB
dc.contributor.authorBRUEGGER Peteren_GB
dc.contributor.authorFREY Estheren_GB
dc.contributor.authorHARTUNG THOMASen_GB
dc.contributor.authorMONTAG LESSING Thomasen_GB
dc.date.accessioned2010-02-25T15:43:39Z-
dc.date.available2007-02-19en_GB
dc.date.available2010-02-25T15:43:39Z-
dc.date.issued2006en_GB
dc.date.submitted2007-01-29en_GB
dc.identifier.citationJOURNAL OF IMMUNOLOGICAL METHODS vol. 316 no. 1-2 p. 42-51en_GB
dc.identifier.urihttp://publications.jrc.ec.europa.eu/repository/handle/JRC36329-
dc.description.abstractPyrogens as fever-inducing agents can be a major health hazard in parenterally applied drugs. For the control of these contaminants, pyrogen testing for batch release is required by pharmacopoeias. This has been done either by the in vivo rabbit pyrogen test (since Î942) or the limulus amoebocyte lysate test (LAL), since 1976. New approaches include cell-based assays employing in vitro culture of human immune cells which respond e.g. by cytokine production (IL-lβ; IL-6) upon contact with pyrogens. Six variants of these assays have been validated in a collaborative international study. The recent successful development of cryopreservation methods promises to make standardized immunoreactive primary human blood ceils available for widespread use. Furthermore, the pretesting of donors for infectious agents such as HIV or hepatitis has made it possible to develop a safe and standardised reagent for pyrogen testing. Using a total of 13 drugs, we have validated the pyrogcn test based on fresh and cryopreserved human whole blood in four laboratories. The test reached >90% sensitivity and specificity. In contrast to the LAL, tlie test was capable of detecting non-endotoxin pyrogens derived from Gram-positive bacteria or fungi.en_GB
dc.description.sponsorshipJRC.I.2-Validation of biomedical testing methodsen_GB
dc.format.mediumPrinteden_GB
dc.languageENGen_GB
dc.publisherELSEVIER SCIENCE BVen_GB
dc.relation.ispartofseriesJRC36329en_GB
dc.titleInternational Validation of Pyrogen Tests Based on Cyropreserved Human Primary Blood Cellsen_GB
dc.typeArticles in periodicals and booksen_GB
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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