The kit is intended for use in determining the presence of host cell DNA contamination in products manufactured by recombinant expression in E.coli. This kit contains the necessary reagents for DNA extraction as well as calibrated DNA standards and primers for DNA amplification in a microtube format. The kit does not contain the PCR master mix. This kit gives you the ability to test samples in very high concentrations of drug substance without the need for excessive sample dilutions. This effectively lowers the LLOQ of the assay when compared to similar methods on the market. Residual DNA can be measured to 1 part per billion when using this kit. Test performed in tubes