TY - JOUR
T1 - Assessment of pyrogenic contaminations with validated human whole-blood assay
AU - Daneshian, Mardas
AU - Von Aulock, Sonja
AU - Hartung, Thomas
PY - 2009/11
Y1 - 2009/11
N2 - We present an internationally validated protocol for the evaluation of pyrogenic contaminations using human whole blood. In the in vitro pyrogen test (IPT) the sample is incubated with fresh or cryopreserved human whole blood, and the proinflammatory cytokine interleukin-1β (IL-1β) is detected by enzyme-linked immunosorbent assay (ELISA). In addition to detecting pyrogenic contaminations in aqueous samples, e.g., parenteral drugs; adaptations allow the assessment of lipidic, toxic or immunomodulatory substances; detection of low-grade contaminations in large-volume parenterals, e.g., dialysis water and fluids; pyrogenicity assessment of solid materials, e.g., medical devices; and evaluation of airborne pyrogenic burden. In contrast to the rabbit pyrogen test and the limulus amoebocyte lysate (LAL) test, it requires no components of animal origin. In comparison with the LAL, it also detects nonlipopolysaccharide pyrogens. In comparison with other monocyte activation tests it requires no cell preparation steps or cell culture facilities. The procedure takes 21-35 h to complete.
AB - We present an internationally validated protocol for the evaluation of pyrogenic contaminations using human whole blood. In the in vitro pyrogen test (IPT) the sample is incubated with fresh or cryopreserved human whole blood, and the proinflammatory cytokine interleukin-1β (IL-1β) is detected by enzyme-linked immunosorbent assay (ELISA). In addition to detecting pyrogenic contaminations in aqueous samples, e.g., parenteral drugs; adaptations allow the assessment of lipidic, toxic or immunomodulatory substances; detection of low-grade contaminations in large-volume parenterals, e.g., dialysis water and fluids; pyrogenicity assessment of solid materials, e.g., medical devices; and evaluation of airborne pyrogenic burden. In contrast to the rabbit pyrogen test and the limulus amoebocyte lysate (LAL) test, it requires no components of animal origin. In comparison with the LAL, it also detects nonlipopolysaccharide pyrogens. In comparison with other monocyte activation tests it requires no cell preparation steps or cell culture facilities. The procedure takes 21-35 h to complete.
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U2 - 10.1038/nprot.2009.159
DO - 10.1038/nprot.2009.159
M3 - Article
C2 - 19893507
AN - SCOPUS:74949109725
SN - 1754-2189
VL - 4
SP - 1709
EP - 1721
JO - Nature protocols
JF - Nature protocols
IS - 12
ER -