An in vitro pyrogen safety test for immune-stimulating components on surfaces

Marina Hasiwa, Karin Kullmann, Sonja von Aulock, Christoph Klein, Thomas Hartung

Research output: Contribution to journalArticle

Abstract

Due to the discovery of novel surgical techniques and new materials medical devices are increasingly used. Contact of these biomaterials with human tissue or blood commonly leads to inflammation of varying degrees, sometimes resulting in severe health problems. Possible causes are limited biocompatibility or pyrogenic contamination of the material. We adapted the recently validated in vitro pyrogen test (IPT), based on human whole blood cytokine release, to test the safety of biomaterials. Human whole blood is brought into direct contact with the surface of the test material and the release of the pro-inflammatory cytokine IL-1β is measured. This procedure represents a human-relevant assay allowing the detection of pyrogens of different origins, e.g. Gram-negative (lipopolysaccharide, LPS) or Gram-positive (lipoteichoic acid, LTA), peptidoglycan (cell wall components of most bacteria) and fungal zymosan by direct material contact. The sensitivity of the test system allows a starting concentration of 10 pg/ml for LPS, 10 ng/ml for zymosan and 1 μg/ml for LTA and peptidoglycan from different strains. Furthermore, we have shown that the test for solid materials can be carried out with cryo-preserved blood, which results in an even lower detection limit.

Original languageEnglish (US)
Pages (from-to)1367-1375
Number of pages9
JournalBiomaterials
Volume28
Issue number7
DOIs
StatePublished - Mar 2007
Externally publishedYes

Fingerprint

Pyrogens
Safety
Blood
Zymosan
Peptidoglycan
Biocompatible Materials
Lipopolysaccharides
Biomaterials
Cytokines
Cellular Structures
Interleukin-1
Acids
Cell Wall
Limit of Detection
Medical problems
Biocompatibility
Inflammation
Assays
Bacteria
Contamination

Keywords

  • Human whole blood
  • In vitro test
  • Lipopolysaccharide
  • Lipoteichoic acid
  • Peptidoglycan
  • Zymosan

ASJC Scopus subject areas

  • Biotechnology
  • Bioengineering
  • Biomedical Engineering

Cite this

An in vitro pyrogen safety test for immune-stimulating components on surfaces. / Hasiwa, Marina; Kullmann, Karin; von Aulock, Sonja; Klein, Christoph; Hartung, Thomas.

In: Biomaterials, Vol. 28, No. 7, 03.2007, p. 1367-1375.

Research output: Contribution to journalArticle

Hasiwa, Marina ; Kullmann, Karin ; von Aulock, Sonja ; Klein, Christoph ; Hartung, Thomas. / An in vitro pyrogen safety test for immune-stimulating components on surfaces. In: Biomaterials. 2007 ; Vol. 28, No. 7. pp. 1367-1375.
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