Developmental Validation of the forensic GEM Universal Kit for the Extraction of Genomic DNA

Commercially available solid-phase DNA extraction kits are commonly used in forensic science today. The forensicGEM™ Universal kit is a new generation approach to DNA extraction that uses a thermophilic proteinase and temperature to yield DNA that is ready for downstream applications. In this study, we describe the developmental validation of the forensicGEM Universal kit in accordance with current validation recommendations. The forensicGEM extraction kit has shown to provide genomic DNA for downstream polymerase chain reaction (PCR)-based applications. DNA was recovered from samples with very low quantities of blood and saliva (0.01–10 μL). Although inhibitors were not physically removed from the extracts through wash steps, amplifications were not inhibited downstream of the forensicGEM extraction. Case-type samples yielded full profiles, devoid of PCR artifacts, where expected, based on quantification of the samples. The developmental validation of the forensicGEM product serves to define the reaction conditions and limitations for its use in routine forensic case work.