The Threshold DNA Detection Assay is a phenol-free DNA extraction method to quantitatively measures picograms of single-stranded DNA.
Unlike hybridization techniques which require DNA probes or primers with a specific nucleic acid sequence, the Threshold Total DNA Assay measures DNA with broad sequence specificity. This enables the Threshold System to measure host cell DNA as well as other DNA that might have been introduced during the biopharmaceutical manufacturing process. In addition, since the assay does not require sequence specific probes or primers, the assay can easily be applied to different samples purified from different host organisms.
The Threshold Total DNA Assay is an established assay recognized by the FDA for DNA contaminate testing and can be used to quantitate residual DNA in final biopharmaceutical products, assay validation and determination of detection limit, plus DNAse I qualification and sample treatment.