Methodology for the assessment of new dichotomous diagnostic tests.

Abstract The correct evaluation of a new diagnostic test requires the knowledge of the true status of the patient. Practically, such a favorable situation is rarely encountered and the status is most usually determined through one or several imperfect reference tests. In this case, a bias is introduced in assessing new diagnostic procedures and prevalence becomes a variable of prominent importance when calculating predictive values as well as sensitivity and specificity. Prevalence also affects the statistical parameters of the new tests in two-stage designs, and corrective procedures are necessary in these instances. This paper focuses an adjustment to be made to allow a correct assessment of new diagnostic procedures in specific situations.

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