STR分型检测仪器性能评价方法研究

Study on the Method for Performance Evaluation of STR Typing Detection Instrument

目的:针对自主研制的GA118-16A遗传分析仪,设计一系列的检测方法以实现对仪器性能的评价。方法:从仪器的迁移速度、灵敏度、重复性、分辨力等方面进行检测方法设计,并进行试验检验。结果:以Gene Scan-500 LIZ为标准物质,根据迁移速度与电场强度关系,在电泳电压大于13KV时可在规定时间内完成500bp片段长度电泳,并进行有效分离,RSD≤2%;仪器的最低上样检测灵敏度可达3.8×10-2ng/μL;能准确分辨1bp差异的DNA片段;重复性RSD≤0.8%。结论:通过设计的实验方法可以对该分析仪的迁移速度、灵敏度等各项性能指标进行较好的评价。

Objective GA 118-16A genetic analyzer is developed independently by our team. In this paper, a series of detection methods to realize the evaluation of the performance of instrument were designed. Methods The detection method was designed based on the migration velocity, the sensitivity of the instrument, the repeatability, resolution and other aspects, and the experimental tests were carried out. Results Taking Gene Scan-500 LIZ as the standard substance, if the eleetrophoretic voltage is higher than 13KV, electrophoresis of DNA fragments around 500bp can be completed timely and effectively, and RSD is less than 2%. The detection sensitivity of instrument is 3.8×10^-2ng/μL, the resolution is lbp, and the RSD is less than 0.8%. Conclusion Through the experimental design, it can be a better evaluation for migration velocity, the sensitivity and the other performance index of GA 118-16A.