Developmental validation of the PowerPlex® Fusion 6C System

TLDR

The PowerPlex® Fusion 6C System is a 27‑locus, six‑dye multiplex that incorporates all expanded CODIS core loci, two rapidly mutating Y‑STRs, and supports both casework and database workflows with direct amplification. The study reports the results of a developmental validation following SWGDAM guidelines, covering species specificity, sensitivity, stability, precision, reproducibility, repeatability, case‑type samples, concordance, stutter, DNA mixtures, and PCR‑based procedures. The multi‑laboratory validation examined extracted DNA and direct amplification samples from various substrates, processed on Applied Biosystems 3500 and 3130 series analyzers, and evaluated the aforementioned performance metrics. The data validate the system’s design and demonstrate its performance.

Abstract

The PowerPlex(®) Fusion 6C System is a 27-locus, six-dye, multiplex that includes all markers in the expanded CODIS core loci and increases overlap with STR database standards throughout the world. Additionally, it contains two, rapidly mutating, Y-STRs and is capable of both casework and database workflows, including direct amplification. A multi-laboratory developmental validation study was performed on the PowerPlex(®) Fusion 6C System. Here, we report the results of that study which followed SWGDAM guidelines and includes data for: species specificity, sensitivity, stability, precision, reproducibility and repeatability, case-type samples, concordance, stutter, DNA mixtures, and PCR-based procedures. Where appropriate we report data from both extracted DNA samples and direct amplification samples from various substrates and collection devices. Samples from all studies were separated on both Applied Biosystems 3500 series and 6-dye capable 3130 series Genetic Analyzers and data is reported for each. Together, the data validate the design and demonstrate the performance of the PowerPlex(®) Fusion 6C System.