Assay integration entails the marriage of molecular diagnostic (MDx) assays, instrumentation, software and consumables to deliver overarching functionality, efficiency, usability and throughput. This includes
- The amalgamation of MDx assays onto a mature platform or a prototype instrument in development.
- Adding of new functionality in the form of hardware and/or software
For the above we provide expertise in the following areas that will ensure smooth integration of MDx assays onto a platform of your choice:
- Optimization of MDx assays (for e.g. workflow, parameters) to achieve client defined performance specifications
- Guard banding studies and establishment of tolerance ranges
- Instrument reliability studies, performance and confidence testing of
new functions
- Establishment of installation, operation and performance qualifications, methods and documentation
- Development and verification of preventive maintenance protocols
- Support for pre and post launch activities that include:
- On-site training and user support for early access/market placement clients
- Generation of training materials for the above purpose
- Training and support for users till knowledge transfer to client is complete