GA118-16A型遗传分析仪技术指标确证测试  

Developmental validation of the GA118-16A genetic analyzer

作　　者：张涛[1] 孙敬[2] 庞晓东[1] 贾二惠[1] 赵颖[1] 崔海涛[1] 李培合[1] 陈力[1] 赵兴春[2] 刘冰[2] 周怀谷[3] 

机构地区：[1]公安部第一研究所,北京102200 [2]公安部物证鉴定中心,北京100038 [3]上海市公安局,上海200083

出　　处：《中国法医学杂志》2015年第1期20-23,共4页Chinese Journal of Forensic Medicine

基　　金：国家十一五科技支撑计划项目(2008BAK45B02)

摘　　要：目的对GA118-16A型遗传分析仪的技术指标进行测试考察,评估其法医学应用价值。方法选择40份男性和42份女性DNA样本、等位基因分型标准物样本、配成6个梯度浓度的9947A标准品、7种混合比例的男/女、女/男两组混合样本(14份),使用3台GA118-16A遗传分析仪进行检测;评价该仪器分型的一致性、重现性、重复性、精确度、分辨力、灵敏度及混合样本分析能力等技术指标。结果经GA118-16A遗传分析仪检测,1男性和女性样本均可获得完整、清晰的分型图谱,结果准确,重现性、重复性良好;2检测精确度SD≤0.12bp;3能准确分辨1bp差异的DNA片段、基线噪声水平、峰高一致性表现良好;4可准确检出各种比例的男女混合样本分型。结论 GA118-16A型遗传分析仪相关技术指标均能满足法医DNA检案和建库等应用要求,可在法医学中推广应用。Objective Perform developmental validation experiments in accordance with Validation Guidelines for DNA Analysis Methods（SWGDAM, Approved December 2012） to evaluate the performance of GAllS-16A genetic analyzer for forensic application. Methods 40 male and 42 female extracted DNA samples; allelic ladder; 9947 control DNA with 6 gradient concentrations; 2 groups mixed samples （male/ female and female/male）, each with mixture ratio of 1：0, 1：1, 1：2, 1：3, 1：5, 1：9 and 0：2, total 14 samples; tested by using 3 GAllS-16A genetic analyzer. To validate genotype concordance, reproducibility and repeatability, sizing precision and resolution, sensitivity and the ability of mixture analysis of GA118-16A genetic analyzer. Results Lab tests show： ①genotype profiles of 40 male and 42 female from three GA118-16A instruments were 100% concordant with each other and with the 3130xl results; ②the SD in sizing was less than 0. 12bp; ③the system can resolve alleles that differ in length by a single base pair, and is good at the baseline noise level and peak height ratio; ④the system can analyze DNA samples with more than one contributor. Conclusion All the results demonstrated that GAll8-16A genetic analyzer can be applied in forensic science, and is suitable for both forensic DNA ease work and database work.

关 键 词：法医物证学 GA118-16A遗传分析仪 确证测试 技术指标 

分 类 号：D919[医药卫生—法医学]