Validation of a rapid DNA process with the RapidHIT ® ID system using GlobalFiler ® Express chemistry, a platform optimized for decentralized testing environments

Abstract

The RapidHIT ID is a fully automated sample-to-answer system for short tandem repeat (STR)-based human identification. The RapidHIT ID has been optimized for use in decentralized environments and processes presumed single source DNA samples, generating Combined DNA Index System (CODIS)-compatible DNA profiles in less than 90min. The system is easy to use, requiring less than one minute of hands-on time. Profiles are reviewed using centralized linking software, RapidLINK™ (IntegenX, Pleasanton, CA), a software tool designed to collate DNA profiles from single or multiple RapidHIT ID systems at different geographic locations. The RapidHIT ID has been designed to employ GlobalFiler Express and AmpFLSTR NGMSElect™, Thermo Fisher Scientific (Waltham, MA) STR chemistries. The Developmental Validation studies were performed using GlobalFiler Express with single source reference samples according to Scientific Working Group for DNA Analysis Methods guidelines. These results show that multiple RapidHIT ID systems networked with RapidLINK software form a highly reliable system for wide-scale deployment in locations such as police booking stations and border crossings enabling real-time testing of arrestees, potential human trafficking victims, and other instances where rapid turnaround is essential.

Results of the 2018 Rapid DNA Maturity Assessment

“…The RapidHIT 200 and RapidHIT ID data were reviewed in GeneMarker HID v2.8.2. Both RapidHIT instruments produced a GeneMarker HID file for analysis which employed dynamic thresholds per locus ; thus, all profiles generated by a RapidHIT instrument were reviewed in GeneMarker HID v2.8.2 within their instrument generated GeneMarker HID file rather than re‐analyzed within GeneMapper IDX v1.5. A heterozygote balance filter of 25% was applied to all samples.…”

“…These advances include rapid PCR protocols for short tandem repeat (STR) typing , advancements in microfluidic efforts for PCR , and separation and detection . All these advancements aided in the several parallel efforts made to integrate the forensic STR analysis workflow and utilize a simple “swab in, answer out” process within a single instrument . The ANDE 6C System, developed by ANDE (Waltham, MA), provides users with a fully integrated device to generate an STR profile using a custom FlexPlex (FP) PCR chemistry containing 27 loci within 90 min .…”

“…The ANDE 6C System, developed by ANDE (Waltham, MA), provides users with a fully integrated device to generate an STR profile using a custom FlexPlex (FP) PCR chemistry containing 27 loci within 90 min . IntegenX (Pleasanton, CA), which is a subsidiary of Thermo Fisher (Waltham, MA), developed the RapidHIT 200 and RapidHIT ID instruments which utilize the GlobalFiler Express (GFE) PCR chemistry containing 24 loci and generate STR profiles in under two hours for the RapidHIT 200 and within 90 min for the RapidHIT ID .…”

Internal Validation of RapidHIT®ID ACE Sample Cartridge and Assessment of the EXT Sample Cartridge*†

“…A second‐generation, sample‐to‐answer Rapid DNA instrument, the RapidHIT ® ID , is a new rapid DNA instrument platform having a compact footprint (10.5″W × 20.5″D × 18.5″H) with the ability to produce a DNA profile from a buccal swab (ACE cartridge) or a DNA extract (EXT cartridge) in approximately 120 min. This instrument differs from IntegenX's first‐generation rapid DNA instrument (RapidHIT ® ) and other rapid DNA systems by processing only one sample at the time.…”

Genomic encryption of digital data stored in synthetic DNA

“…For the selected markers (PI17+AM = ∏(PISTR)) equals to 6.9x10 -22 , which is about one in a trillion human populations. As STR profiles can be measured exact and essentially error-free 32 , this low number can be considered as the false acceptance rate (FAR) of the biometric measurement, and is significantly lower than the false acceptance rate of currently utilized biometric technologies (face recognition and fingerprint analysis), making it exceptionally interesting in protecting highly valuable information. This is, of course, also the reason why DNA analysis utilizing STR profiles is regarded as the gold standard in forensic analysis.…”