scope:

EP12 provides product design guidance and protocols for performance evaluation of the Establishment and Implementation Stages of the Test Life Phases Model of examinations (see CLSI document EP19¹). EP12 characterizes a target condition (TC) with only two possible outputs (eg, positive or negative, present or absent, reactive or nonreactive). EP12 is written for both manufacturers of qualitative, binary, results-reporting or output examinations (referred to as qualitative, binary examinations throughout) and medical laboratories that create laboratory-developed, binary examinations (both termed developers). These protocols are also intended to help users verify examination performance in their own testing environment. Performance evaluation of examinations that provide outputs with more than two possible categories in an unordered (nominal) set or that report ordinal categories are outside the scope of this guideline.