IVD Clinical Performance
Bioexcel supports prospective IVD clinical performance studies, evaluating diagnostic sensitivity, specificity, PPA and NPA against a scientifically justified comparator.
Bioexcel can support prospective recruitment where the study requires:
Study Requirements
- Fresh specimens
- Intended-use population
- Real clinical workflow
- Clinical diagnosis
- Point-of-care use
- Layperson use
- Self-testing
- Paired sample collection
Bioexcel Support
- Site feasibility
- Investigator selection
- Participant recruitment
- Consent process
- Sample collection
- Reference testing
- Index testing
- Monitoring
- Data management
- Statistics
- CPSR
Clinical Performance Metrics
- Diagnostic sensitivity
- Diagnostic specificity
- PPA
- NPA
- Overall agreement
- Predictive values where appropriate
- Likelihood ratios where appropriate
- ROC analysis
- Concordance
- Discordance
- Subgroup performance
