The relative light units result must indicate less than 2 X 10-12 mg/µl of ATP for the product to be certified as ATP free. Luminescence data is compared to results generated by ATP-free surfaces and surfaces with known amounts of ATP as a positive control. Product sample surfaces are tested for the presence of adenosine triphosphate (ATP) using a controlled bioluminescence reaction to detect contamination. Extraction fluid samples must show no degradation of the nucleic acids by the extraction fluid has occurred for the product to be certified as RNase-free and DNase-free Results are visualized on an agarose gel with appropriate positive and negative controls.
Product samples are exposed to nuclease-free water and the resulting extraction fluid is tested for nuclease activity on commercially available 7.5 kb Poly(A) tailed RNA (1µg) and HindIII-digested DNA (1µg) with a one hour 37☌ incubation in appropriate buffers. All products tested must display less than 0.05 EU/ml to be certified free of endotoxin. Product samples are exposed to endotoxin-free water and the resulting extraction fluid is tested for contamination using the kinetic turbidimetric Limulus Amoebocyte Lysate (LAL) assay protocol and USP guidelines.