The recombinant Factor C assay is equivalent to other photometric endotoxin methods that use LAL to
detect endotoxins according to the parameters listed in the USP chapter
<<1225>> “Validation of Compedial Procedures”. These
parameters include linearity, specificity, precision, accuracy, and limit of
The PyroGene™ rFC Assay has the ability to detect
endotoxin in comparable fashion to LAL-based methods. The rFC method
recognizes endotoxin from different source materials similar to other photometric
procedures, such kinetic chromogenic LAL and kinetic turbidimetric LAL.