SureID^(■) PanGlobal试剂盒的法医学验证

Forensic Validation for the SureID^(■) PanGlobal Kit

目的测试Sure ID~?Pan Global人类DNA身份鉴定试剂盒(简称Sure ID~?Pan Global试剂盒)的技术性能指标,评估其法医学应用价值。方法根据GA/T 815-2009标准,从检测灵敏度和准确性、峰均衡性、常见动物的种属特异性、各种常见检材的适应性和一致性、对酶切降解和混有抑制剂检材的耐受性、不同批次间试剂的稳定性及混合样本的检测等9个方面对Sure ID~?Pan Global试剂盒进行测试。结果 Sure ID~?Pan Global试剂盒内标及Ladder符合GA/T 815-2009标准的要求,阳性样本分型正确,检测的灵敏度和均衡性也均较高,不同批次的试剂反复冻融10次后仍可获得正确分型,对降解检材及混有抑制剂的样本具有一定的耐受性,能检测不同类型的检材,具有种属特异性和混合样本检测能力。结论 Sure ID~?Pan Global试剂盒的上述性能指标符合GA/T815-2009标准的要求,达到了目前常用STR检测试剂盒的技术水平,可用于个体识别、亲权鉴定及遗传学分析,适合法医学检案与建库应用。

Objective To evaluate the technical performance and forensic applicability of the Sure ID？ Pan Global Human DNA Identification kit. Methods In compliance with the GA/T 815-2009, the Sure ID？ Pan Global kit was verified in nine terms of sensitivity, accuracy, balance, species specificity, adaptability, consistency, stability, survivability and mixed samples. Results The Sure ID？ Pan Global kit meets the professional requirements with its internal standard and ladder, together with the accuracy of positive controls, the excellent detection sensitivity, the balance and the species specificity. All the results were correct with 10 repetitive freezing-thawing cycles of the kit. The endurance was shown by the kit against either the degraded or the inhibitor-spiked DNA samples under certain conditions. The genetic polymorphisms were successfully detected with a variety of diversely-disposed DNA samples, along with the consistency of their genotyping results. Conclusions All the tests demonstrated that Sure ID？ Pan Global Human DNA Identification kit is adaptive to the requirements for the human fluorescent STR multiplex PCR reagent. Since its technical level has reached up to that of the similar international products, the kit can be used in personal identification, paternity test and genetic analysis, suitable for handling actual criminal cases and DNA database building.