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Developmental validation of the DNAscan™ Rapid DNA Analysis™ instrument and expert system for reference sample

Angelo Della Manna1, Jeffrey V Nye2, Christopher Carney3

  • 1Alabama Department of Forensic Sciences, 2026 Valleydale Road, Hoover, AL 35244, USA.

Forensic Science International. Genetics
|September 9, 2016
PubMed
Summary

Rapid DNA analysis systems can now perform forensic STR analysis outside traditional labs. The DNAscan system, validated across multiple labs, reliably genotypes reference samples with high accuracy and an integrated expert system.

Keywords:
Buccal swabsCODISDevelopmental validationRapid DNA analysisShort tandem repeat

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Area of Science:

  • Forensic Science
  • Molecular Biology
  • Genetics

Background:

  • Forensic DNA typing has traditionally required laboratory analysis by trained personnel.
  • Rapid DNA technology offers potential for expanded testing and analysis outside traditional laboratory settings.

Purpose of the Study:

  • To developmentally validate the DNAscan/ANDE Rapid DNA Analysis System for forensic STR analysis.
  • To assess the system's ability to reliably genotype reference samples in compliance with FBI Quality Assurance Standards.

Main Methods:

  • Utilized the BioChipSet™ Cassette for high DNA content samples (buccal swabs).
  • Conducted multi-laboratory testing involving over 2300 swabs from nearly 1400 unique individuals.
  • Evaluated the integrated Expert System for automated data analysis and allele calling.

Main Results:

  • The DNAscan System produced high-quality, concordant results for reference buccal swabs.
  • Demonstrated reproducibility and reliability across seven external laboratories and the developer.
  • The integrated Expert System achieved over 99.998% concordant alleles, correctly flagging samples for review.

Conclusions:

  • The DNAscan System is a reliable and reproducible tool for forensic STR analysis outside traditional laboratories.
  • The integrated Expert System accurately genotypes samples with minimal human intervention.
  • The system meets industry standards for precision, resolution, and sensitivity for buccal swab analysis.