Significant discrepancies between our new assay and the comparator assay can sometimes happen where an unacceptable number of discrepancies occurs during the course of assessing accuracy, such that acceptance criteria is not met. This may be a result of a low number of samples such that it is statistically impossible (or near impossible) to meet acceptance criteria. For example, a laboratory selects 20 samples for assessing accuracy with acceptance criteria of 95% positive percent agreement. If two discrepancies occur, accuracy has not been verified or validated. The purpose of assessing analytical specificity is to ensure that the assay is detecting only the analyte of interest, and not another organism or another substance in the sample or reaction. For approved assays, if unexpected cross-reactivity or interference occurs during verification studies, laboratory personnel should reach out to the manufacturer to discuss known issues and potential resolutions.