Performance Evaluation Report (PER) for a MGIT Identification Test
A global leader in the Medical industry.
Project Scope
- The Performance Evaluation Studies for both analytical and clinical parameters were previously done based on IVDD 98/79/EC that needed cross-check of all relevant data
- There was very specified scientific literature found
- Co-relation of clinical evidence with scientific validity and performance studies
- Constructing state of the art was challenging
Project Deliverables
PER tool kit including:
- Performance evaluation plan (PEP)
- Analytical performance report (APR)
- Clinical performance report (CPR)
- Scientific validity report (SVR)
- Performance evaluation report (PER)
Key Tools
- Ovid MEDLINE®
- PubMed
- Scopus
- Google Scholar
