2023 Volume 28 Issue 2 Pages 159-167
The Scientific Working Group on DNA Analysis Methods (SWGDAM) validation guidelines for DNA analysis method indicate that when material modifications are made to an existing procedure that may affect the results of the analysis, the concordance between the results before and after the modifications should be confirmed. In this study, we modified our conventional procedure for mitochondrial DNA (mtDNA) analysis by changing the mtDNA quantification and sequence product purification methods along with and without changing the version of the data collection software and/or sequencing analysis software. We performed mtDNA analysis using the four modified procedures and ensured the concordance between the results obtained before and after the modifications. The sensitivity was also confirmed to be comparable among the conventional and all the modified procedures. Therefore, we concluded that the modifications can be adopted in the procedures for our mtDNA analysis.