  THE DEVELOPMENT AND VALIDATION OF A RAPID MILLIFLUIDIC DNA ANALYSIS SYSTEM FOR FORENSIC CASEWORK SAMPLES
 Summary: Funded by the EU Seventh Framework Programme, the Forensic Science Service is leading a consortium of world-leading forensic, academic and industrial partners to deliver a validated instrument (MiDAS) for rapid processing of forensic samples.
DESCRIPTION
Objective: MiDAS will deliver a self-contained, portable instrument to produce DNA database compatible results from crime samples in 2 hours. Automated processes for DNA analysis of large numbers of samples are now used in many of the EU member states; however the most efficient of these high throughput systems can take 3-5 days to produce DNA database-compliant profiles. In high profile crime and terrorism cases it is crucial to access DNA results promptly to provide intelligence to investigators.
Currently a small number of samples can be processed in less than 24h but the method is labour intensive and expensive. MiDAS proposes a real-time, simple-to-operate and cost effective alternative. MiDAS will rely heavily on the expertise of the consortium members and will build on the current project between the Forensic Science Service and University of Arizona (Hopwood et al Anal. Chem. 2010, 82, 6991-6999, http://onlinelibrary.wiley.com/doi/10.1002/elps.201000305/abstract) to deliver a robust, reliable instrument adaptable to the needs of multiple EU agencies. The design will allow processing of small numbers of samples at the scene of a crime, in an office environment or in the laboratory. Samples will be directly introduced to the device; no further manual involvement will be required.
DNA will be extracted using magnetic bead technology and transferred to reaction chambers for quantification and amplification which will be controlled to normalise the DNA profile. The profile will be visualised following analysis through on-cartridge DNA separation and laser induced fluorescence based detection. Automated data analysis using expert systems will facilitate the timely delivery of a profile. The requirements for implementation of the instrument into the forensic process will be determined, including an evaluation of relevant legislative and data protection requirements.
Successful forensic validation of the instrument and subsequent validation of the full forensic process designed around the instrument will allow implementation of MiDAS to the forensic community within the partner EU member states, enabling the delivery of early DNA intelligence to law enforcement and security agencies.
PROJECT DETAILS
The project objectives will be achieved through the delivery of 9 work packages:
Work Package 1: Technical Specification
The objective of WP1 is to properly define and agree the specification for a cartridge-based fully integrated millifluidic device for forensic DNA analysis. Calling on all project participants to draw on their own fields of expertise, we will ensure the system is defined so as to fulfil internationally agreed guidelines for the analysis of DNA in a forensic context.
Work Package 2: Prototype Development
The objective of WP2 is to develop and evaluate the prototype DNA analysis device. The instrument will be developed to meet the technical specifications as defined by WP1 and tested against the agreed acceptance criteria. Any optimisation of the final system will take place here and implemented changes will be re-evaluated.
Work Package 3: Instrument and Software Validation
The objective of WP3 is to validate the prototype instrument delivered from WP2 in accordance with the validation plan delivered in WP1.
Work Package 4: Process Integration
The objective of WP4 is to properly define the process whereby the instrument is integrated into the forensic organisation and how it will integrate with current processes. An understanding of the technological, organisational and human implications of implementation will allow an assessment of the impact to be made. We will also try to evaluate the impact the successful implementation of a rapid DNA analysis system might have on society as a whole.
Work Package 5: System Validation and Implementation
Following successful delivery of WP3, it is necessary to validate the end to end forensic system or process into which the instrument will fit. The strategic objective of WP5 is to properly define, agree and deliver the system validation. This process is likely to be different in different jurisdictions. It is essential therefore to incorporate knowledge from all the end user partners in the consortium and to identify those parties interested in early implementation of the instrument to their own process. A successful outcome of this process will see the process accredited for loading DNA profiles to a national DNA database. Such profiles are likely to be utilised in the sharing of data in accordance with the Prüm treaty (see WP6).
Work Package 6: Data Protection
The strategic objective of WP6 is to properly define, agree and deliver the Data Protection required by the project to industry standards and EU guidelines.
Work Package 7: Device and System Scalability
The main objective of this work package to produce a number of strategic plans to allow the device to be developed allowing it to be commercially viable and to consider manufacturability.
Work Package 8: Exploitation and Dissemination
The strategic objective of WP8 is to make the results of the project available to professionals in the fields of law enforcement and security, such that the general public benefit directly through the enhanced capability to investigate crime and acts of terrorism. Its aim is to ensure a credible and flexible route to exploitation which will facilitate implementation in a range of European and international forensic and judicial systems.
Work Package 9: Consortium Management and Reporting to the EC
The overall objective of work package 9 is to ensure that the project is managed in an effective and efficient manner and meets all obligations in term of budget, reporting, milestones and deliverables.
CONSORTIUM MEMBERS
Forensic Science Service: Gill Tully (Dr), Andy Hopwood (Dr), Shellie Coles (Ms), Cecilia Buffery (Ms), Keith Elliott (Mr)
Grid Xitek Limited: Jeremy Saunders (Mr), Gary Ross (Mr)
Medizinische Universitaet Innsbruck: Walther Parson (Professor), Burkhard Berger (Dr)
Bundeskriminalamt: Ingo Bastisch (Dr), Eva Müller (Dr)
Netherlands Forensic Institute: Ate Kloosterman (Dr), Kees van der Beek (Dr)
Arizona Board Of Regents: Frederic Zenhausern (Professor), Ralf Lenigk (Dr), Patrick Jones (Mr)
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