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.

中文翻译：

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ANDE 6C快速DNA分析系统与传统方法的对比分析


快速 DNA 分析是一种超快且全自动的 DNA 分型系统，可在 90 分钟内从生物样本中生成可解释的遗传图谱。这种“拭子输入-轮廓输出”方法包括 DNA 提取、多重 PCR 扩增、毛细管电泳分离和检测 DNA 片段。研究的目的是根据 ISO/IEC 17025 标准验证加速核 DNA 设备 (ANDE) 6C 系统作为参考样品的分型方法。在这里，我们通过将 ANDE 6C 系统生成的遗传图谱与标准技术生成的遗传图谱进行比较来报告结果的有效性和再现性的评估。通过ANDE 6C技术和传统方法（DNA提取和定量、毛细管电泳扩增和分离）对104份口腔拭子进行了分析。 ANDE 6C 技术在 97% 的病例中观察到阳性分型，只有三个口腔拭子未能显示可解释的信号。通过比较 ANDE 6C 和传统技术生成的等位基因调用来确定一致性。 2800个基因型的比较显示一致性率为99.96%。这些结果符合 ISO/IEC 17025 要求，使我们能够获得该方法的认证。最后，快速技术无疑已达到一定的可靠性水平，使其在法医遗传学实验室中的应用成为现实。