DNATyper^TM15试剂盒的确证试验

目的测试DNATyper^TM15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、灵敏度、混合样本、批次间试剂稳定性及批量样本测试、DNA提取方法适应性测试、各类常见检材的测试、稳定性测试等8个方面进行测试。并与Identifiler^TM PowerPlex16剂盒进行比较。结果DNA Typer TM15试剂盒灵敏度较高，批次间性能稳定，对各类案件检材和DNA提取方法具有较好的适应性，具有检验混合DNA样本检测的能力。结论DNA Typer TM15在上述性能指标等方面已经达到国际同类产品的技术水平，可用于法庭科学的检案与建库。

Validation of the DNATyperTM 15 PCR amplification kit

Objective Developmental validation studies were designed according to the standards of forensic DNA community on DNATyperTM15 kit,which simultaneously amplifies 14 STR loci(D6S1043、D21S11、D7S820、CSF1PO、D2S1338、D3S1358、D13S317、D8S1179、D16S539、Penta E、D5S818、VWA、D18S51、FGA)and amelogenin,a sex-determining locus.Methods Several key factors were tested including:Ⅰ.amount of hot-start Taq polymerase;Ⅱ.annealing temperature;Ⅲ.sensitivity;Ⅳ.reaction volume;Ⅴ.cycle number;Ⅵ.primer concentration.DNATyperTM15 was also compared with two other widely used commercial STR amplification kits,namely IdentifilerTM and PowerPlex.Results No difference in performance was observed with three lots of DNATyperTM15.Performance was not affected even after 20 times of repeated freeze-and-thaw.All three kits performed comparably in the following aspects:Ⅰ.sensitivity;Ⅱ.ability to genotype mixed samples;Ⅲ.amplification of DNA from various sample sources.DNA extraction methods(Chelex-100,magnetic beads,silica beads)did not result in any observable effect on performance with any of the three kits.Conclusion All the results demonstrated that DNATyperTM15 is suitable for both forensic DNA database work and casework.