Human cell-based pyrogen test

TNF-a, as previously discussed. Test methods have been designed that include incubation of a test sample with monocytes in whole blood or in cultured cell lines and analysis of a specific cytokine after a suitable time. This cell-based methodology may provide an alternative to rabbit pyrogen testing that is required for human blood products. More development is needed to determine the optimum cytokine for analysis and to assess the nature of interference conditions. 

Hoffmann S, Peterbauer A, Schindler S, Fennrich S, Poole S, Mistry Y et al (2005) International validation of novel pyrogen tests based on human monocytoid cells. J Immunol Methods 298 161-173... 

Schindler S, Spreitzer I, Loschner B, Hoffmann S, Hennes K, Haider M et al (2006) International validation of pyrogen tests based on cryopreserved human primary blood cells. J Immunol Methods 316 42-51... 

A third test, the monocyte activation test (MAT) is based on the in-vitro activation of human blood cells by pyrogens. This leads to the release of pro-inflammatory cytokines tumoiu necrosis factor alfa (TNF-alfa), interleukin-1 beta (BL-lbeta) and interleukin-6 (IL-6) that are determined by Enzyme-Linked Immiuio Sorbent Assay (ELISA). Consequently, the MAT will detect the presence of both exogenous and endogenous pyrogens in the test sample. The MAT is suitable, after a product-specific validation, as a replacement for the rabbit pyrogen test [50]. 

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