Internal Validation of Promega's Powerplex 16 System

Condel, Kevin R., Internal Validation Study of Promega’s Powerplex 16 System. Master of Science (Forensic Genetics), August, 2005, 83 pp., 18 tables, 8 illustrations, bibliography, 14 titles. In the environment surrounding a court case, the United States Justice System requires that DNA evidence presented in a court of law be reliable, robust, and reproducible. For DNA laboratories to uphold these strict guidelines, all methods and instrumentation used in the lab must undergo validation studies. A validation study will measure the ability of the laboratory to perform a new method or use new instrumentation on a variety of samples before casework can be performed, ensuring that the method or instrumentation is indeed reliable, robust, and reproducible. This study consists of the validation of Promega’s PowerPlex 16 kit on the ABI 3100 Avant Genetic Analyzer instrumentation for Identigene, located in Houston, Texas. The validation consists of sensitivity, routine, mixture, non-probative, allelic ladder size precision, and matrix evaluations. Completion of these studies allow Identigene to begin performing casework using the PowerPlex 16 Kit. A validation study of the Takayama Reagant for Identigene was also performed. This procedure is used when a substance is presumed to be blood and the laboratory personnel want to confirm the presence of heme. The study consisted of a test determining the amount of reducing agent to add to the reagent, a dilution study, and substrate studies, and after these tests were performed indicated the ineffectiveness of the Takayama procedure for the purposes of Identigene.