Middleware Solutions To Improve Molecular Diagnostics; Connectivity, Quality Control And Lean Processes

HGM Niesters1, F Klein1, J Poodt2
1Department of Medical Microbiology, Division of Clinical Virology, UMC Groningen; 
2LabHelp, Bladel, The Netherlands

Objectives: Molecular diagnostic laboratories currently have implemented devices from nucleic isolation to real-time detection, including pipetting robots, mostly from different companies to manage their diagnostic processes. With increasing quality control demands (ISO15189, GAMP5), these processes do become critical components in patient management. Our MiddleWare solution FlowG improves lab processes and QC demands.
Methods: Our MiddleWare is linked to a Laboratory Information System using Microsoft Access and Visual Basic for Applications. All processes are analyzed for critical steps, automated and subsequently validated. The software is implemented around our routine laboratory diagnostic set-up.
Results: Three different isolation robots, six pipetting robots and eight ABI7500 devices are linked. All information ont control reagents (internal and positive controls) are used for assay validation. For quantitative laboratory developed assays, values are automatically assigned based on validated and pre-calculated standard curves. QC data are available in the database to enable time independent evaluation of reagents and controls. The software is validated along the GAMP5 guidelines for risk analysis. Asides routine diagnostics, the FlowG concept is expanded to sequence analysis. These processes are now an integrated part of the software.
Conclusion: Our MiddleWare solution is the first to enable connectivity between devices from different vendors. The implementation is within an ISO-regulated manner and make our diagnostic processes more LEAN. Furthermore, developments towards using this solution for sequencing and QC purposes are implemented and enhances patient care.

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