Guideline References

Evaluation of Qualitative, Binary Output Examination Performance (3rd Edition, 2023)

The primary standard governing the design and analysis of qualitative binary examination performance. EP12 (3rd ed.) covers precision (imprecision near the cutoff using C5/C50/C95 samples), clinical performance (sensitivity and specificity when a best available assessment of target condition is used), and agreement (PPA and NPA when the comparator is not a gold standard). The minimum recommended sample size for verification of clinical performance or agreement is at least 20 specimens, with an approximately equal distribution of positive and negative results. EP12 recommends the Wilson score method for calculating confidence intervals. Important scope note: EP12 is explicitly limited to binary (two-category) output examinations; ordinal examinations with more than two result categories are outside its scope.

CAP Checklist Requirement

CAP requires that laboratories document a comparison of patient results between the new and existing (or reference) method prior to placing a new method into service. For qualitative tests, this includes documentation of positive and negative agreement with the established method. Comparison data must be retained as part of the laboratory's quality and validation records.

Standard: Establishment and Verification of Method Performance Specifications

CLIA requires laboratories to verify or establish method performance specifications — including accuracy relative to a comparison method — for all non-waived tests before reporting patient results. For qualitative methods, this verification must include agreement with a reference procedure using clinical specimens.