Gray Zone Matters
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*Kristen Meier, FDA, CDRH  *Vicki Petrides, Abbott Diagnostics 

Keywords: gray zone, equivocals, indeterminant, agreement

How do you report results comparing two tests when both are considered qualitative but there are equivocal results (also called gray zone or indeterminate results) for either test? Most statisticians agree that equivocal results must be reported in the tables and included in agreement calculations. The question is how to include these results in the calculations and what should we call these measures? This presentation will address different ways these calculations are performed and how the different approaches can affect the conclusions regarding the performance of the tests relative to each other.