NIST validation studies on the 3500 Genetic Analyzer

An internal validation of the Applied Biosystems 8-capillary 3500 Genetic Analyzer was performed using two commercial short tandem repeat (STR) multiplex kits (Identifiler and Identifiler Plus). Validation experiments to evaluate the performance of this CE consisted of a precision study, sensitivity study, genotype concordance, a two person mixture study, and signal normalization evaluation. The sensitivity study consisted of duplicate injections of amplified DNA template ranging from 1.0 ng down to 0.01 ng. These male samples were heterozygous at all loci. Statistical evaluation of the sensitivity data was performed to determine the statistical significance between employing a single threshold across all dye channels and opting for dye specific thresholds. Published by Elsevier Ireland Ltd.