Abstract
Rapid DNA analysis is an ultrafast and fully automated DNA-typing system, which can produce interpretable genetic profiles from biological samples within 90 minutes. This “swab in—profile out” method comprises DNA extraction, amplification by PCR multiplex, separation and detection of DNA fragments by capillary electrophoresis. The aim of study was the validation of the Accelerated Nuclear DNA Equipment (ANDE) 6C system as a typing method for reference samples according to the ISO/IEC 17025 standard. Here, we report the evaluation of the validity and reproducibility of results by the comparison of the genetic profiles generated by the ANDE 6C System with those generated by standard technologies. A quantity of 104 buccal swabs were analyzed both through the ANDE 6C technology and the traditional method (DNA extraction and quantification, amplification and separation by capillary electrophoresis). Positive typing was observed in 97% of cases for ANDE 6C technology with only three buccal swabs failing to reveal interpretable signals. Concordance was determined by comparing the allele calls generated by ANDE 6C and conventional technology. Comparison of 2800 genotypes revealed a concordance rate of 99.96%. These results met the ISO/IEC 17025 requirements, enabling us to receive the accreditation for this method. Finally, rapid technology has certainly reached a level of reliability which has made its use in laboratories of forensic genetics a reality.
Highlights
Forensic DNA analysis plays an important role in criminal investigations and assisting identification of victims in large-scale disasters
The Accelerated Nuclear DNA Equipment (ANDE) 6C Rapid DNA Analysis System successfully analyzed 97% of biological samples
Concordance was determined by comparing the allele calls generated by ANDE 6C with the DNA profile of the same person produced comparing the allele calls generated by ANDE 6C with the DNA profile of the same person produced by the conventional technology
Summary
Forensic DNA analysis plays an important role in criminal investigations and assisting identification of victims in large-scale disasters. The analysis of DNA forensic sample requests standardized and shared protocols through ultra-sensitive methods [1,2]. The need for shared methods is managed and assessed through the accreditation of laboratories according to the UNI CEI EN ISO/IEC 17025 standard, which certifies their competence by ensuring the reliability of the results. It promotes cooperation between laboratories and other bodies by generating wider acceptance of results between countries.
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