Lonza PyroGene rFC assay

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The PyroGene recombinant Factor C assay (rFC) assay represents a reliable, sustainable alternative to LAL.

Factor C is the first component in the horseshoe crab clotting cascade activated by endotoxin. Recombinant Factor C (rFC) is activated by endotoxin binding, and the active enzyme then cleaves a synthetic substrate, resulting in the generation of a fluorogenic compound.

The reaction is run in a 96-well microplate and is measured at time zero and after a one-hour incubation in a fluorescent microplate reader using 380 nm excitation/440 nm emission wavelengths. The log net fluorescence is proportional to the log endotoxin concentration and is linear in the 0.01-10 EU/mL range.

Benefits include: endotoxin specific, recombinant technology eliminates false-positive glucan reactions; predictable, reliable lot-to-lot assay performance; sustainable resource - no animal utilisation; endpoint fluorescent assay, comparable to other quantitative LAL methods; and 510 (K) submissions have been approved by the FDA using PyroGene rFC Assay as a final release test.