1. Performance Basic and Advanced Statistics
Data collection and analysis from samples provided by the client. (antigen tests and reference data provided by client)
1a. Laboratory analysis of performance and LoD (Proteins)
Laboratory validation of antigen test prototypes or antibody pairs and targets using dilutions of purified protein
1b. Laboratory analysis of performance and LoD (Contrived samples)
Laboratory validation of antigen test prototypes or antibody pairs and targets using contrived samples
1c. Statistics on clinical samples and laboratory performance evaluation
Laboratory validation of antigen test using IDx20 retrospectively collected clinical samples
1d. Performance evaluation on clinical studies
Clinical validation of antigen test using IDx20 collected clinical samples under an IRB-approved research protocol for home testing.