Analytical validation study of the RapidHIT™ ID and RapidLINK™ v2.0.1 system to generate and process profiles with ACE GlobalFiler™ Express cartridge

The Applied Biosystems™ RapidHIT™ ID System 1 1 For Forensics, Human Identification or paternity/Kinship Use Only. Not for use in diagnostic procedures. is a highly automated and simple-to-use instrument that produces trusted laboratory-quality forensic DNA short tandem repeat (STR) profiles in as little as 90 minutes. The system has been optimized for use in decentralized environments and for processing presumed single-source DNA samples, generating Combined DNA Index System (CODIS)-compatible DNA profiles. The system delivers reliable, reproducible, high-quality electrophoretic data with management software that enables real-time access, review, and control of STR profiles. The RapidHIT™ ID instrument and RapidLINK™ v2.0.1 software validation studies were performed using Applied Biosystems ACE GlobalFiler™ Express sample cartridges with single source reference samples in accordance with the FBI Quality Assurance Standards [1,2] and guidelines from the Scientific Working Group for DNA Analysis Methods (SWGDAM) [3]. The results from these validation studies are reported here for sensitivity, specificity, inhibitors, size precision, concordance, contamination and carryover, mixtures, and reproducibility and repeatability. In addition, it is demonstrated that multiple RapidHIT ID systems networked with RapidLINK form a highly reliable system for wide-scale deployment in locations such as police booking stations and Ports of Entry, enabling real-time testing of arrestees, potential human trafficking victims and other instances where rapid turnaround is essential. • The system demonstrated high pass success rates; a total of 500 unique single source genotypes were generated with a first pass rate (no quality flags) of 86.3% and with analyst review, the second pass rate was 94.9%. • Sizing accuracy is within 0.3 base pairs (bp), allowing accurate genotyping and robust identification of alleles separated by 1 bp. • Full passing profiles were obtained with as little as 1 buccal swipe. • The system effectively flagged 2-person mixtures as expected, indicating the presence of multiple donors. • Validation study results confirmed the system's adherence to FBI Quality Assurance Standards and SWGDAM guidelines, making it suitable for decentralized environments and laboratory facilities.