CLSI EP12-A2 Test Standard for User Protocol for Evaluation of Qualitative Test Performance

This guide provides protocols for the evaluation of qualitative test performance characteristics. In this standard, a qualitative test is limited to tests with only two possible results (for example, positive/negative, present/absent, reactive/non-reactive). The EP12 was written primarily for individuals and laboratories that use and evaluate such tests. These protocols are intended to help users determine test performance in their own test environment. This guide to qualitative test performance evaluation should assist the device developer and user in achieving documentation and regulatory goals. Although this standard is not designed for manufacturers to specify test performance characteristics, the data analysis principles described here can be used by manufacturers.

For example, test methods with values ​​reported as negative, +1, +2, or +3 or as endpoint dilutions (usually multiples of 8 or multiples of 10 reflecting the microtiter plate format) are often referred to as. These methods are not discussed further in EP12, but if one of the value results is considered the threshold for a positive test, the evaluation protocol proposed here can be applied to this breakpoint.

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