Verogen’s Validation and Implementation Services

Verogen offers Validation and Implementation services following SWGDM guidelines to enable labs to submit casework using the MiSeq FGx instrument.

Verogen Validation and Implementation Services

The MiSeq FGx® Forensic Genomics Solution is the first fully validated, FBI NDIS approved next generation sequencing system for genomic DNA analysis of forensic samples. Verogen offers a variety of validation and implementation services that enable your lab to get online with the MiSeq FGx as quickly as possible. Verogen’s Field Application Scientists can assist with planned, assisted, or full validations depending on your laboratory’s unique needs. Implementation services are also offered upon request.

Validation Product Offerings

Customers are provided with the necessary reagents and protocols for all validation offerings. Customers can complete the validation, data analysis, and reporting on their own with the Planned Validation service. Customers perform the experiments and Field Application Scientists assist with data analysis and reporting with Assisted Validation. Field Application Scientists perform the experiments, data analysis, reporting, and teach back the validation with a Full Validation offering.

 PlannedAssistedFull
9 Standard Flow Cell Kits (up to 9 Sequencing Runs) & 1 ForenSeq Lib Prep Kit (DPMB, 384 rxns)YesYesYes
Validation Planning & Templates ProvidedYesYesYes
1 Week On-site (Customer runs)NoYesNo
4 Weeks On-site (FAS runs)NoNoYes
Data Analysis and Internal Report (includes Basic Guidelines)NoYesYes
1 Week On-site TeachbackNoNoYes
Data Analysis and ReportsNoYesYes

Comprehensive Validation Studies

Experiments are designed to follow SWGDAM Guidelines which validate the MiSeq FGx for use with casework samples. The following studies are provided as a plan or completed for all Validation services.

Mock/Known/Nonprobative Samples

  • System performance with various case samples
  • Concordance to current methods

Sensitivity & Stochastic

  • Profile Completeness & Accuracy
  • Reach Count Intensity

Precision & Accuracy

  • Reproducibility (between different library preps, runs & users)
  • Repeatability (within same library prep, run & user)

Mixtures

  • DNA Mixture Detection

Contamination

  • Extraneous reads assessment

Sample Multiplexing

  • Comparison of 8- to 32-plex samples per run on Standard Flow Cell

Supplemental Evaluation

  • In addition to validation of identity testing data (STRs & iiSNPs), a supplemental evaluation is completed for the investigative intelligence data (ai/piSNPs) if desired

Contact techsupport@verogen.com to learn more about Validation and Implementation services.

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