The PyroGene™ Recombinant Factor C Assay is the evolution of endotoxin detection testing. Lonza scientists have produced a recombinant form of Factor C, 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 excitation/emission wavelengths of 380/440 nm. The log net fluorescence is proportional to the log endotoxin concentration and is linear in the 0.01-10 EU/ml range.
Advantages of the PyroGene™ rFC Assay:
- Endotoxin
- specific, recombinant technology eliminates false-positive glucan reactions
- Predictable, reliable lot-to-lot assay performance
- Sustainable resource – no animal utilization
- Endpoint fluorescent assay, comparable to other quantitative LAL methods
- 510(K) submissions have been approved by the FDA using PyroGene™ rFC Assay as a final release test
- Comprehensive FDA Master File