User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline
|Publication Date:||1 January 2008|
This guideline provides protocols for the evaluation of
qualitative test performance characteristics. In this document, a
qualitative test is restricted to those tests that have only two
possible outcomes (eg, positive/negative, present/absent,
Test methods with values that are reported as, for instance, negative, +1, +2, or +3, or as endpoint dilutions (commonly in multiples of 8, reflecting the microtiter plate format, or in multiples of 10) are often called semiquantitative. These methods are not further discussed in EP12, although if one of the values results is considered the cutoff for a positive test, the evaluation protocol recommended here could be applied to that cutoff. For instance, if a test for antibodies to the Lyme disease pathogen was reported as positive if the endpoint titer was ≥ 1:160, the precision and method comparison experiments discussed below could be applied to that cutoff.