| 摘要 |
Inflammatory activity contaminating a medical device or biologic agent can greatly affect both its safety and its efficacy. Disclosed are methods of detecting inflammatory activity in a test sample by administering the test sample to an animal and detecting the level of a pro-inflammatory cytokine or other cell-derived mediator of inflammation. Elevated levels of pro-inflammatory cytokines such as IL-1, IL-6, TNF-a, or IFN-?, or of other cell-derived mediators of inflammation such as lysosome granules, histamine, IL-8, leukotriene B4, nitric oxide, or prostaglandin E2 (PGE2), indicate that the test sample has inflammatory activity. The inflammatory activity may be due to any pro-inflammatory factor, such as a bacterial endotoxin (e.g., a lipopolysaccharide) or a non-endotoxin pyrogen (e.g., a Streptococcal mucopeptide). |
