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Performance Evaluation Report (PER) for a MGIT Identification Test
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
PER tool kit including:
Performance evaluation plan (PEP)
Analytical performance report (APR)
Clinical performance report (CPR)
Scientific validity report (SVR)
Performance evaluation report (PER)
Ovid MEDLINE®
PubMed
Scopus
Google Scholar
Case Studies
We have provided a few projects which we have executd for our customers. Please reach out to us for more details