Standard for Validation Studies of DNA Mixtures, and Development and Verification of a Laboratory’s Mixture Interpretation Protocol

This standard sets forth the requirements for the design and evaluation of internal validation studies for mixed DNA samples and the development of appropriate interpretation protocols for mixtures based on the validation studies performed. This standard includes a requirement that the laboratory verify and document that the mixture interpretation protocols developed from the completed validation studies generate reliable and consistent interpretations and conclusions for the types of mixed DNA samples typically encountered by the laboratory. This standard applies to any type of DNA testing technology and methodology used, including but not limited to, STR testing, DNA sequencing, SNP testing, haplotype testing, traditional and rapid protocols, etc., where mixtures of DNA may be encountered, analyzed and interpreted.