Assessment of pyrogenic contaminations with validated human whole-blood assay

Mardas Daneshian, Sonja Von Aulock, Thomas Hartung

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)1709-1721
Number of pages13
JournalNature protocols
Issue number12
StatePublished - Nov 1 2009

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)


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