EndoZyme® II Recombinant Factor C (rFC) Assay

** Since 1 July 2016, Recombinant Factor C (rFC)-based endotoxin tests are approved for use as alternative methods to conventional LAL according to chapter 5.1.10 of the European Pharmacopoeia **

The EndoZyme® II assay, available since May 2017, is the enhanced second generation of EndoZyme® - an endpoint fluorescent microplate assay intended for in vitro quantitative determination of endotoxin in pharmaceuticals and biological substances as well as for medical device testing.

The endotoxin-specificity of EndoZyme® II eliminates all false-positive and elevated results seen by ß-glucan reactions in the LAL test. Adding the excellent sensitivity, ease-of-use and very high lot-to-lot consistency, the LAL alternative EndoZyme® II is a representative of modern recombinant methods, moving away from the animal source which for decades has been the horseshoe crab.

Being a homogeneous assay without solid phase, EndoZyme® II is particularly suited for non-complex samples and buffer conditions, such as water testing. For complex sample matrices, EndoLISA® is recommended.

All reagents needed for running EndoZyme® II are included in the kit:

EndoZyme II Recombinant Factor C (rFC) Endotoxin Detection Assay

EndoZyme® II, Item no. 890030 (192 tests)

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Included: Enzyme (recombinant Factor C), Substrate, Endotoxin Standard, Water (free of detectable levels of endotoxin), Assay Buffer, Assay Plates (2 x 96 wells).

Specifications and advantages:

  • Highly sensitive rFC endotoxin detection assay with measurement range 0.005 - 50 EU/ml
  • No false-positive glucan reaction due to endotoxin-specific recombinant technology
  • Excellent reliability and lot-to-lot reproducibility
  • All needed reagents included in the kit
  • Flexible testing format: microtiter plate
  • No animal material, therefore saving the diminishing horseshoe crab population

Additional material needed:

  • Fluorescence microplate reader
  • Lab shaker/vortex mixer
  • Endotoxin-free disposables and glassware