Performance Assessment of Binary Output Examinations in Medical Laboratories
Content
The determination of clinical sensitivity and specificity of tests for binary disease detection is critical to ensure these tests are sufficiently reliable.
Clinical sensitivity (SP), also known as the True Positive Rate, describes the probability of correctly detecting a disease case. Clinical Specificity (SS), also known as the True Negative Rate, expresses the ability to correctly identify the absence of a disease.
Since the accuracy of the determined SP and SS depends on the number of tested known disease cases, it is important to determine the confidence intervals for estimates of the performance parameter. These confidence intervals are subsequently used to decide if the actual performance and its quantification method are adequate.
This leaflet provides an overview of what is involved in these crucial assessments.
Availability
The second edition is currently available in English.
- Download the leaflet in English [691 kb] (2025-05-30)*
* Dates are the date of addition to this website
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Validation of analytical methods (i.e. procedures) usually excludes the primary sampling, but this is now widely recognised as the first step in the measurement procedure. Validation of the whole measurement procedure therefore requires consideration of a performance characteristic that reflects the quality of all of the steps (including sampling and physical sample preparation). The uncertainty of the final measurement value is that key characteristic that unifies this whole measurement procedure and enables its validation, particularly when supported by performance characteristics that have an established role in the validation of an analytical procedure as a standalone activity.
