Objective To test the technical performance indexs of domestic GoldenEye? 16BT kit,and to evaluate the application ability of forensic medical. Methods Nine key factors were tested including genotyping method of amplified kit, precision and accuracy,peak height balance,sensitivity,different kits and stability,survivability,adaptability and consistency for various samples sources, species specificity, mixed DNA sample. Results Points of DNA positive samples were right, and internal standard and alleles points that meet the requirements of type standard in GoldenEye? 16BT kit. The balance of between the allele frequency≥73% .balance of between the same fluorescent marker loci≥57% .balance of between different markers≥ 81%. In positive 0.125 0 ng DNA samples could be detected all short tandem repeat (STR) loci classification and ABO blood group genotype,kit test of between different batches and after repeated freeze-thaw could acquire correct classification,and it had certain tolerability to degradation of inspection material and mixed with inhibitor samples, and it could parting to various of inspection materials and classification results were agreed,there were a certain species specificity and mixed DNA testing ability. Conclusion Domestic GoldenEye? 16BT kit can be used for actual inspection and built libraries in forensic science.%目的 测试国产GoldenEyeTM 16BT试剂盒的技术性能指标,评估其法医学应用能力.方法 制定测试方案,从方法学验证、准确性、峰值均衡性、灵敏度、批次间试剂及稳定性测试、耐受性、不同检材的适应性与一致性、种属特异性、混合样本等9个方面进行测试.结果 GoldenEyeTM 16BT试剂盒阳性DNA样本分型正确,内标和等位基因分型标准物符合要求；等位基因间的均衡性≥73％,同一荧光标志基因座间的均衡性≥57％,不同标志物间的均衡性≥81％；对阳性0.125 0 ng的DNA样本能检出全部短串联重复序列(STR)基因座分型和ABO血型基因型,不同批次间和反复冻融后试剂盒测试可以获得正确分型,对降解检材和混有抑制剂的样本等具有一定的耐受性,可对案件中多种检材进行分型且分型结果一致,具有一定的种属特异性和混合DNA样本检测的能力.结论 国产试剂盒GoldenEyeTM 16BT可用于法庭科学的实际检案与建库.
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