APPENDIX 2

Performance Parameters1 for AOAC7 Methods Validation Programs
AOAC7 Official MethodsK K Quantitative Methods 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Specificity Linearity Limit of Detection Limit of Quantitation Precision (Intralaboratory Repeatability) Comparison to Reference Method Ruggedness Matrix Recovery Laboratory Reproducibility2 Package insert review3 Quality Policy Certification4 Qualitative Methods 1. Specificity rate 2. Sensitivity rate 3. False Positive and False Negative Rates 4. Percent method Agreement 5. Ruggedness 6. Matrix 7. Recovery 8. Inter-Laboratory Reproducibility5 9. Package insert review6 10. Quality Policy Certification7 AOAC7 Performance Tested MethodsK K Quantitative Methods 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Specificity Linearity Limit of Detection Limit of Quantitation Precision (Intralaboratory Repeatability) Comparison to Reference Method Ruggedness Matrix Recovery Limited Laboratory Reproducibility8 Package insert review Quality Policy Certification Qualitative Methods 1. Specificity rate 2. Sensitivity rate 3. False Positive and False Negative Rates 4. Percent method Agreement 5. Ruggedness 6. Matrix 7. Recovery 8. Limited Inter- Laboratory Reproducibility9 9. Package insert review 10. Quality Policy Certification4 AOAC7 Peer-Verified MethodsK K Quantitative Methods 1. 2. 3. 4. 5. 6. Specificity Linearity Limit of Detection Limit of Quantitation Precision (Intralaboratory Repeatability) Comparison to Reference Method Ruggedness Matrix Recovery
Reproducibility10

Qualitative Methods 1. Specificity rate 2. Sensitivity rate 3. False Positive and False Negative Rates 4. Percent method Agreement 5. Ruggedness 6. Matrix 7. Recovery 8. Limited Inter-Laboratory
Reproducibility11

7. 8. 9. 10. Limited Laboratory

1. Not all performance parameters specified in this table are applicable to all analytes or all methods. The appropriate parameters to be included in the analysis are defined 2. 3. 4. 5. 6. 7.

8.
9.

10. 11.

by the GR, Methods Committees, and OMB for OMA methods. For PT and PV methods, they are defined by the GR and expert reviewers with final approval by the GR. As defined in AOAC guidelines for conducting collaborative study. For proprietary methods only. For proprietary methods only. As defined in AOAC guidelines for conducting collaborative study. For proprietary methods only. For proprietary methods only. Performance Tested MethodsK evaluated according to the USDA-FSIS memorandum of understanding include laboratory reproducibility studies. Performance Tested MethodsK evaluated according to the USDA-FSIS memorandum of understanding include laboratory reproducibility studies. Some Peer-Verified MethodsK evaluations may include laboratory reproducibility data. Some Peer-Verified MethodsK evaluations may include laboratory reproducibility data.

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