An in vitro pyrogen safety test for immune-stimulating components on surfaces

The human whole blood pyrogen test – lessons learned in twenty years

“…), incriminated samples and > 80 products, direct comparisons to rabbit testing; not disturbed by adjuvants Variants: commercial kit available 1 , medical devices/solid materials (Hasiwa et al, 2007), airborne pyrogens (Kindinger et al, 2005), adsorb/wash-extraction/enrichment (Daneshian et al, 2006(Daneshian et al, , 2008, cell therapies (Montag et al, 2007), one-plate assay (Poole et al, 2003) 1 http://bit.ly/1xB1WmS…”

“…In contrast to the LAL, the whole blood test reflects the potency of different LPS species in the rabbit (Fennrich et al, 1999a). Since a cell suspension is used, blood as a reagent can be brought into contact with any material, including medical devices (Hasiwa et al, 2007;Mazzotti et al, 2007) or filters loaded with specimens from air samples (Kindinger et al, 2005). In contrast, cell lines in the validation study showed drifts and shifts in their responsiveness to pyrogens, letting MonoMac-6 cells fail the prevalidation and the two THP-1 tests fail the validation phase.…”

“…The obvious advantage of the whole blood MAT over the classical test methods is that the whole blood comes into direct contact with the respective device and no preparation of an eluate is required (Hasiwa et al, 2007). This has been demonstrated using aneurysm clips as proof of principle (Mazzotti et al, 2007).…”

Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test

“…In contrast to the lAl/Bet, the whole blood MAt reflects the potency of different LPS species in the rabbit (Fennrich et al, 1999a). Since a cell suspension is used, blood as a reagent can be brought in contact with any material, including medical devices (Hasiwa et al, 2007;Mazzotti et al, 2007) or filters loaded with specimens from air samples (Kindinger et al, 2005). In contrast, cell lines in the validation study have shown drifts and shifts in their responsiveness to pyrogens, letting MonoMac-6 cells fail the prevalidation and the two tHP-1 tests fail the validation phase.…”

Development, validation and applications of the monocyte activation test for pyrogens based on human whole blood

“…the alternative of transplanting the questionable material directly into the rabbit is highly invasive, causing possible reactions not associated with pyrogenic contaminations but rather with tissue damage, and is therefore questionable in its ethical and scientific implications. the obvious advantage of the WBt over the classical test methods is that the whole blood comes into direct contact with the respective device and no preparation of an eluate is required (Hasiwa et al, 2007). this has been demonstrated using aneurysm clips as proof of principle (Mazzotti et al, 2007).…”