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OMB MEETING MATERIALS

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

Background  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.

08/09/2018