The Spectrum CE System is an automated 8-capillary electrophoresis instrument intended for separation and detection of fluorescently-labeled DNA fragments, including short tandem repeat (STR) markers. The CE instrument is compatible with existing five- and six-dye-labeled STR kits available from Promega and other commercial vendors. It is also compatible with the Promega 8-dye STR kits. The system supports automated analysis of up to four 96-well sample plates.

The developmental validation summary describes experiments performed on the Spectrum CE System following applicable standards and guidelines outlined in the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories (1) and the Scientific Working Group on DNA Analysis Methods (SWGDAM) Validation Guidelines for DNA Analysis Methods (2).

The report describes the following characteristics of the Spectrum CE System:

• Baseline noise and threshold evaluation
• Precision, resolution, accuracy
• Reproducibility
• Sensitivity
• Signal variability
• Dye balance
• Spectral artifact analysis
• Contamination assessment
• Mixture samples
• Direct amplification

Up to six different STR chemistries were used in these validation studies (see table below). Three Spectrum CE Systems were used for each study, unless otherwise noted (System 1, 2, and 3). Spectrum Control Software (SCS) version 3.0.0 (8) was run on each system.