Correcting Diagnostic Test Sensitivity and Specificity for Patient Misclassifications Resulting from Use of an Imperfect Reference Standard.

ABSTRACT: Investigational diagnostic tests are validated by using a reference standard (RS). If the RS is imperfect (i.e., it has sensitivity [Se] and/or specificity [Sp] < 1), incorrect values for the investigational test's Se and Sp may result because of patient misclassification by the RS. Formulas were derived to correct a test's Se and Sp that were determined by using an imperfect RS. The following derived formulas correct for misclassification and give the true numbers of disease-positive [n_DP] and disease-negative patients [n_DN] from the apparent number of disease-positive and disease-negative patients (an_DP and an_DN), and the Se and Sp of the RS (Se_R, Sp_R): n_DP = (an_DP × Sp_R + an_DN

SUBMITTER: Sherwin PF 

PROVIDER: S-EPMC9818831 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature