FSIS Guidance for Evaluating Test Kit Performance

II. General Guidance for Evaluation of Pathogen Test Kit Performance 1. Purpose, Scope and Audience 2. General Considerations 3. Inoculum Number of strains Strain selection (Table 1) Preparation of inoculum Inoculation of matrix 4. Matrix Choice of matrix (Tables 2a, Table 2b) Decision Criteria Illustrating When New Validation Studies Should be Conducted for an Existing Method Characterization of matrix 5. Study Design and Analysis Paired and Unpaired studies (Figure 1) Data Analysis Levels of validation (Figure 2, Table 3) Reference method 6. Sample size Unpaired studies (Figure 3) Paired studies (Figure 4) 7. Study report