Services

Why use Real World Diagnostics' Assay Development Service?

Real World Diagnostics' team of experienced development scientists will work alongside customers through each stage of the development process, providing updates, advice and joint troubleshooting regarding the development of the rapid IVD test kits.

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Phase 1: Feasibility

A development plan to conduct a feasibility study will be prepared based on the specifications. At the end of the feasibility study a report will be prepared and submitted along with a small number of early prototype tests.

Phase 2: Optimization

A robust and reproducible test that fulfils the customer specification will be produced. A wide range of materials including membranes, coating buffers, conjugation parameters, buffer release pads and sample pads are evaluated using proven protocols.

Phase 3: Validation

The validation stage involves the preparation and submission of a validation plan and the manufacture of three independent lots using different batches of critical materials. Prior to the validation batches, draft Application Notes will be prepared and used to conduct the three batch validation.

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