•The PowerQuant¨r) System was developed to quantify human DNA and assess sample quality.•A developmental validation following SWGDAM guidelines was completed.•Degraded DNA, inhibited samples, and mixtures of male/female DNA were evaluated.•Results demonstrate reliability, reproducibility and suitability for forensic use.•The PowerQuant¨r) System distinguishes degraded samples from inhibited samples. Quantification of the total amount of human DNA isolated from a forensic evidence item is crucial for DNA normalization prior to short tandem repeat (STR) DNA analysis and a federal quality assurance standard requirement. Previous commercial quantification methods determine the total human DNA and total human male DNA concentrations, but provide limited information about the condition of the DNA sample. The PowerQuant¨r) System includes targets for quantification of total human and total human male DNA as well as targets for evaluating whether the human DNA is degraded and/or PCR inhibitors are present in the sample. A developmental validation of the PowerQuant¨r) System was completed, following SWGDAM Validation Guidelines, to evaluate the assay
tm)s specificity, sensitivity, precision and accuracy, as well as the ability to detect degraded DNA or PCR inhibitors. In addition to the total human DNA and total human male DNA concentrations in a sample, data from the degradation target and internal PCR control (IPC) provide a forensic DNA analyst meaningful information about the quality of the isolated human DNA and the presence of PCR inhibitors in the sample that can be used to determine the most effective workflow and assist downstream interpretation.