AOAC Method Validation (August 29, 2018)

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

Background X About ten years ago, AOAC and others, recognized that the “false positive rates”, “false negative rates”, and “sensitivity” concepts are flawed in several respects: • 1) the concentration level for false positive/negative rate is not usually specified; • 2) the prevalence of the target is not taken into account, specifically, the predictive value for especially low incidence analytes is not considered, • 3) the statistically validity, i.e., the number of samples used to determine is uncontrolled.

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

Background X AOAC developed a concept known as the “Probability of detection”, or POD. X The POD model combines the sensitivity, specificity, false-positive, and false-negative parameters into one single parameter that covers all contingent ranges of concentration, both zero and non- zero. The POD model incorporates all of the performance concepts of these systems into a single parameter. X The POD statistical model was approved by the AOAC Official Methods Board on December 6, 2010.