title: Developmental validation of a fully integrated sample-to-profile rapid human identification system for processing single-source reference buccal samples.
abstract: Short tandem repeat (STR) DNA typing is a global standard for human identification. Current practice involves highly trained forensic analysts, operating in a laboratory setting, using multiple instruments to process samples and analyze the data. Here, we report the developmental validation of a fully integrated and automated DNA profiling system, the RapidHIT® System, capable of producing up to five high quality STR profiles with full controls in approximately 90min using PowerPlex®16 HS RapidHIT chemistry. The system integrates all sample handling steps: starting from lysis of cells on buccal swabs or other buccal sample types through DNA extraction, normalization, amplification,capillary array electrophoresis, detection, and integrated software analysis. The results describe the developmental validation of the RapidHIT™ System for buccal samples processed with the DNA IQ™ extraction chemistry using a guandinium chaotropic agent and paramagnetic beads followed by amplification using a modified version of PowerPlex 16 HS chemistry (PowerPlex 16 HS RapidHIT chemistry), and capillary electrophoresis with manual review of genotyping data following interpretation guidelines. All processing from the buccal swab to generation and processing of the profile occurs on the RapidHIT platform.
  
  
  RESULTS
  are concordant with traditional methods, with 88% first pass success rates for both the CODIS and PowerPlex 16 loci. Average peak height ratios were 0.89 for buccal swabs. The system produces full profiles from swabs with at least 176 ng of saliva DNA. Rapid DNA identification systems will significantly enhance capabilities for forensic labs, intelligence, defense, law enforcement, refugee and immigration applications, and kinship analysis.
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA. Electronic address: stevanj@integenx.com.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.lastname: Bogdan
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
authors.forename: Richard
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.lastname: Buscaino
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: National Institute of Standards and Technology, Gaithersburg, MD 20899-8314, USA.
authors.forename: Erica L R
authors.initials: ELR
authors.lastname: Butts
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.lastname: Franklin
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
authors.forename: Stefanie
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.lastname: Stainton
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.lastname: Troup
authors.affiliation: National Institute of Standards and Technology, Gaithersburg, MD 20899-8314, USA.
authors.forename: Peter M
authors.initials: PM
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authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.lastname: Vangbo
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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authors.lastname: Woudenberg
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
authors.forename: David
authors.initials: D
authors.lastname: Wyrick
authors.affiliation: IntegenX Inc. 5720 Stoneridge Drive, Suite 300, Pleasanton, CA 94588-2739, USA.
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mesh_terms: D018732:Forensic Anthropology; D006801:Humans; D018895:Microsatellite Repeats / Q000235:genetics; D009061:Mouth Mucosa / Q000378:metabolism*; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results
keywords: Buccal swabs; CODIS; DNA profiling; Forensics; Human identification; Integrated sample-to-profile; PCR; Rapid DNA; Short tandem repeats (STR); system