AOAC Method Validation (August 29, 2018)

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

2. Method developers may include the use of “false positive rates”, “false negative rates”, and “sensitivity” levels in their method descriptions and manuscripts provided the well-known flaws are addressed: • The concentration level must be provided when “false positive/negative rates” are provided. • The “false positive/negative rates” must be based on a minimum 95% confidence interval. A minimum 95% confidence interval can be achieved with 30 correct analyses out of 30 analyses. Numbers of samples and data must be included. • Use ISO 16140-2 for instructions on “false positive rates”, “false negative rates”, and “sensitivity” levels calculations.

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

Proposed Recommendations

3. AOAC should reach out to those organizations still using “false positive/negative rates”, specifically A2LA and FDA, but also to other organizations that use “false positive/negative rates”.