title: Highly sensitive pyrogen detection on medical devices by the monocyte activation test.
abstract: Pyrogens are components of microorganisms, like bacteria, viruses or fungi, which can induce a complex inflammatory response in the human body. Pyrogen contamination on medical devices prior operation is still critical and associated with severe complications for the patients. The aim of our study was to develop a reliable test, which allows detection of pyrogen contamination on the surface of medical devices. After in vitro pyrogen contamination of different medical devices and incubation in a rotation model, the human whole blood monocyte activation test (MAT), which is based on an IL-1β-specific ELISA, was employed. Our results show that when combining a modified MAT protocol and a dynamic incubation system, even smallest amounts of pyrogens can be directly detected on the surface of medical devices. Therefore, screening of medical devices prior clinical application using our novel assay, has the potential to significantly reduce complications associated with pyrogen-contaminated medical devices.
authors.affiliation: Clinical Research Laboratory, Department of Thoracic, Cardiac and Vascular Surgery, University Hospital Tuebingen, Tuebingen University, Calwerstr. 7/1, 72076, Tuebingen, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Stang
authors.forename: Stefan
authors.initials: S
authors.lastname: Fennrich
authors.forename: Stefanie
authors.initials: S
authors.lastname: Krajewski
authors.forename: Sandra
authors.initials: S
authors.lastname: Stoppelkamp
authors.forename: Iwan Anton
authors.initials: IA
authors.lastname: Burgener
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Wendel
authors.forename: Marcell
authors.initials: M
authors.lastname: Post
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D004866:Equipment Contamination; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects* / Q000382:microbiology* / Q000592:standards; D006801:Humans; D053583:Interleukin-1beta / Q000032:analysis; D008070:Lipopolysaccharides / Q000032:analysis / Q000633:toxicity; D009000:Monocytes / Q000187:drug effects* / Q000276:immunology; D011749:Pyrogens / Q000032:analysis* / Q000633:toxicity*; D013499:Surface Properties; D013682:Teichoic Acids / Q000032:analysis / Q000633:toxicity
chemical_list: D053583:Interleukin-1beta; D008070:Lipopolysaccharides; D011749:Pyrogens; D013682:Teichoic Acids; C009900:lipoteichoic acid