AOAC Method Validation (August 29, 2018)

False Positive/False Negative Rates/Sensitivity vs. Probability of Detection (POD)

Background X We are advised that laboratory accreditation organizations (A2LA?) require that false positive/negative rates are reported. X We have been advised that laboratories seeking accreditation are required to report “false positive rates”, “false negative rates”, and “sensitivity” levels as a part of their accreditation, and given these accreditation requirements, test kit companies selling AOAC- approved test kits to these laboratories also seek to include “false positive rates”, “false negative rates”, and “sensitivity” in their approved methods.

False Positive/False Negative Rates/Sensitivity vs. Probability of Detection (POD)

Proposed Recommendations

1. AOAC Expert Review Panels shall continue to rely on the POD model described in Appendix I for biological threat agent methods; Appendix J for food microbiology methods; Appendix K for botanical and dietary supplement methods; and Appendix N for qualitative chemistry methods to evaluate the analytical performance of candidate methods.