Developmental validation of the GlobalFiler(®) express kit, a 24-marker STR assay, on the RapidHIT(®) System.

Rapid DNA typing provides a transformative solution to help forensic laboratories and law enforcement agencies solve and prevent crimes. The RapidHIT(®) System is a fully integrated instrument with a simplified user interface enabling an operator to run the system and obtain a DNA profile from a sample in less than two hours. The integration and developmental validation of the NDIS-approved 24 loci GlobalFiler(®) Express kit expands the capabilities of the RapidHIT System to increase discrimination power, reduce adventitious matches, and improve cross-border data sharing capabilities. Developmental validation studies were performed according to the SWGDAM guidelines and tested several critical areas of performance including three sensitivity studies, inhibited samples, thermal cycling parameters, and cross-contamination. Validation studies indicate that the optimized PCR parameters and sensitivity of the system is capable of generating STR profiles from buccal or blood swab reference samples. Results were concordant with genotypes produced using standard bench thermal cyclers and capillary electrophoresis platforms. Furthermore, swabs can be retrieved from the system and re-run or reprocessed with traditional bench chemistries, e.g. Y-STRs, to gain additional information. Our results demonstrate that the GlobalFiler Express assay run on the RapidHIT System is reliable for generating profiles from reference samples after forensic review.