Publikation:

In vitro pyrogen test : a new test method for solid medical devices

Lade...
Vorschaubild

Dateien

2007Mazzotti_JBiomedMaterRes_bearb.pdf
2007Mazzotti_JBiomedMaterRes_bearb.pdfGröße: 165.57 KBDownloads: 1504

Datum

2007

Autor:innen

Mazzotti, Francesca
Beuttler, Julia
Zeller, Richard
Fink, Ulrich
Schindler, Stefanie

Herausgeber:innen

Kontakt

ISSN der Zeitschrift

Electronic ISSN

ISBN

Bibliografische Daten

Verlag

Schriftenreihe

Auflagebezeichnung

DOI (zitierfähiger Link)
ArXiv-ID

Internationale Patentnummer

Angaben zur Forschungsförderung

Projekt

Open Access-Veröffentlichung
Open Access Green
Core Facility der Universität Konstanz

Gesperrt bis

Titel in einer weiteren Sprache

Publikationstyp
Zeitschriftenartikel
Publikationsstatus
Published

Erschienen in

Journal of Biomedical Materials Research : A. 2007, 80(2), pp. 276-282. ISSN 1549-3296. eISSN 1552-4965. Available under: doi: 10.1002/jbm.a.30922

Zusammenfassung

Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by limulus amoebocyte lysate assay, by injecting the rinsing solutions into rabbits or by implanting batch samples into rabbits and measuring change of body temperature. In this study, we show that the in vitro pyrogen test (IPT), which measures the release of the inflammatory cytokine IL-1β in fresh or cryopreserved human whole blood, can be used to assess the pyrogenic contamination of implantable medical devices. This test was used to check neurosurgical implants, namely aneurysm clips, as a proof of principle. Owing to the direct contact of the test material with the blood cells, this test does not require rinsing procedures, which have variable efficacy. The use of human blood ensures the detection of all substances that are pyrogenic for humans and reflects their relative potency. The safety of the products as delivered could be confirmed. The effects of sterilization and depyrogenization procedures on intentional pyrogenic contaminations of samples could be followed. This new application of the already internationally validated method promises to replace further rabbit pyrogen tests. It generates extremely sensitive results with an extended range of detectable pyrogenic contaminants.

Zusammenfassung in einer weiteren Sprache

Fachgebiet (DDC)
570 Biowissenschaften, Biologie

Schlagwörter

pyrogen testing, human, medical device, whole blood, lipopolysaccharide

Konferenz

Rezension
undefined / . - undefined, undefined

Forschungsvorhaben

Organisationseinheiten

Zeitschriftenheft

Zugehörige Datensätze in KOPS

Zitieren

ISO 690MAZZOTTI, Francesca, Julia BEUTTLER, Richard ZELLER, Ulrich FINK, Stefanie SCHINDLER, Albrecht WENDEL, Thomas HARTUNG, Sonja von AULOCK, 2007. In vitro pyrogen test : a new test method for solid medical devices. In: Journal of Biomedical Materials Research : A. 2007, 80(2), pp. 276-282. ISSN 1549-3296. eISSN 1552-4965. Available under: doi: 10.1002/jbm.a.30922
BibTex
@article{Mazzotti2007vitro-6960,
  year={2007},
  doi={10.1002/jbm.a.30922},
  title={In vitro pyrogen test : a new test method for solid medical devices},
  number={2},
  volume={80},
  issn={1549-3296},
  journal={Journal of Biomedical Materials Research : A},
  pages={276--282},
  author={Mazzotti, Francesca and Beuttler, Julia and Zeller, Richard and Fink, Ulrich and Schindler, Stefanie and Wendel, Albrecht and Hartung, Thomas and Aulock, Sonja von}
}
RDF
<rdf:RDF
    xmlns:dcterms="http://purl.org/dc/terms/"
    xmlns:dc="http://purl.org/dc/elements/1.1/"
    xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#"
    xmlns:bibo="http://purl.org/ontology/bibo/"
    xmlns:dspace="http://digital-repositories.org/ontologies/dspace/0.1.0#"
    xmlns:foaf="http://xmlns.com/foaf/0.1/"
    xmlns:void="http://rdfs.org/ns/void#"
    xmlns:xsd="http://www.w3.org/2001/XMLSchema#" > 
  <rdf:Description rdf:about="https://kops.uni-konstanz.de/server/rdf/resource/123456789/6960">
    <dc:creator>Mazzotti, Francesca</dc:creator>
    <dc:contributor>Mazzotti, Francesca</dc:contributor>
    <dcterms:issued>2007</dcterms:issued>
    <dc:contributor>Fink, Ulrich</dc:contributor>
    <dc:contributor>Wendel, Albrecht</dc:contributor>
    <dc:date rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2011-03-24T17:30:26Z</dc:date>
    <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:contributor>Hartung, Thomas</dc:contributor>
    <foaf:homepage rdf:resource="http://localhost:8080/"/>
    <dc:contributor>Aulock, Sonja von</dc:contributor>
    <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/52"/>
    <dc:creator>Zeller, Richard</dc:creator>
    <dcterms:abstract xml:lang="eng">Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by limulus amoebocyte lysate assay, by injecting the rinsing solutions into rabbits or by implanting batch samples into rabbits and measuring change of body temperature. In this study, we show that the in vitro pyrogen test (IPT), which measures the release of the inflammatory cytokine IL-1β in fresh or cryopreserved human whole blood, can be used to assess the pyrogenic contamination of implantable medical devices. This test was used to check neurosurgical implants, namely aneurysm clips, as a proof of principle. Owing to the direct contact of the test material with the blood cells, this test does not require rinsing procedures, which have variable efficacy. The use of human blood ensures the detection of all substances that are pyrogenic for humans and reflects their relative potency. The safety of the products as delivered could be confirmed. The effects of sterilization and depyrogenization procedures on intentional pyrogenic contaminations of samples could be followed. This new application of the already internationally validated method promises to replace further rabbit pyrogen tests. It generates extremely sensitive results with an extended range of detectable pyrogenic contaminants.</dcterms:abstract>
    <dc:contributor>Zeller, Richard</dc:contributor>
    <dcterms:rights rdf:resource="https://rightsstatements.org/page/InC/1.0/"/>
    <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:creator>Wendel, Albrecht</dc:creator>
    <dc:contributor>Beuttler, Julia</dc:contributor>
    <bibo:uri rdf:resource="http://kops.uni-konstanz.de/handle/123456789/6960"/>
    <dcterms:bibliographicCitation>First publ. in: Journal of Biomedical Materials Research : A ; 80 (2007), 2. - S. 276-282</dcterms:bibliographicCitation>
    <dc:language>eng</dc:language>
    <dc:creator>Fink, Ulrich</dc:creator>
    <dcterms:title>In vitro pyrogen test : a new test method for solid medical devices</dcterms:title>
    <dc:contributor>Schindler, Stefanie</dc:contributor>
    <dc:creator>Hartung, Thomas</dc:creator>
    <dspace:hasBitstream rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/6960/1/2007Mazzotti_JBiomedMaterRes_bearb.pdf"/>
    <dcterms:hasPart rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/6960/1/2007Mazzotti_JBiomedMaterRes_bearb.pdf"/>
    <dc:creator>Schindler, Stefanie</dc:creator>
    <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/52"/>
    <dc:creator>Beuttler, Julia</dc:creator>
    <dc:format>application/pdf</dc:format>
    <dc:creator>Aulock, Sonja von</dc:creator>
    <void:sparqlEndpoint rdf:resource="http://localhost/fuseki/dspace/sparql"/>
    <dc:rights>terms-of-use</dc:rights>
  </rdf:Description>
</rdf:RDF>

Interner Vermerk

xmlui.Submission.submit.DescribeStep.inputForms.label.kops_note_fromSubmitter

Kontakt
URL der Originalveröffentl.

Prüfdatum der URL

Prüfungsdatum der Dissertation

Finanzierungsart

Kommentar zur Publikation

Allianzlizenz
Corresponding Authors der Uni Konstanz vorhanden
Internationale Co-Autor:innen
Universitätsbibliographie
Ja
Begutachtet
Diese Publikation teilen