Data for: Validation of ABI 3500xL Genetic Analyzer after decommissioned and recommissioned at new permises

This validation was aimed to demonstrate that there is no effect on the Applied Biosystems® 3500xL Genetic Analyzer (Thermo Fisher Scientific®, UK) after decommissioned and recommissioned at new premises. Same sample sets were tested on the ABI 3500xL Genetic Analyzer at both old and new premises using current accredited procedures. The results showed genotyping concordance which means using the ABI 3500xL Genetic Analyzer at the new premises provides no risk regarding the accuracy, precision and reproducibility of the results and also showed a very good performance on sensitivity, specificity, repeatability and good profile quality based on the assessment of locus peak balance and peak height.

本验证旨在证明，将应用生物系统（Applied Biosystems®）3500xL基因分析仪（赛默飞世尔科技（Thermo Fisher Scientific®），英国）在原场地停机撤场并搬迁至新场地后重新启用，不会对该设备的性能造成负面影响。本实验采用现行经认可的检测规程，在新旧两处场地的ABI 3500xL基因分析仪上对同一套样本开展检测。结果显示两组检测存在基因分型一致性，表明在新场地使用该ABI 3500xL基因分析仪不会对检测结果的准确性、精密度与可重复性带来风险；同时基于基因座峰平衡及峰高的评估，该设备在灵敏度、特异性、重复性方面表现优异，且分型图谱质量良好。