Assay Verification and Validation
Verification and validation of diagnostic assays are part of the downstream of the pipeline of the 3 core services or as a stand-alone service package provided by Dx assays. This would include testing of the analytical sensitivity, specificity, robustness, precision and cross contamination, which will be performed in accordance to the guidelines provided by Clinical and Laboratory Standards Institute (CLSI).
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Assay Verification: Assay and workflow verification and validation specified by clients and according to regulatory requirements (IVDD 98/79 EC, FDA)
- Verification planning and execution based on client specific design input
- Verification plans and reports in client specified format
- Assay Validation: Assay and workflow validation specified by clients and according to regulatory requirements (IVDD 98/79 EC, FDA)
- Validation planning
- Execution of assay validation work in-house
- Coordination with clinical research organization for allocation of clinical specimens, establishment of study plan and site management when required for multicenter studies
- Generation and execution of validation plans and reports according to client specified formats