Summary of Statistical Methods Commonly Used in Clinical Evaluation of in Vitro Diagnostic Reagents

Abstract

Referring to relevant normative documents, we summarized the commonly used statistical methods in clinical evaluation of in vitro diagnostic reagents. For qualitative and semi-quantitative products, we introduced the clinical interpretation and application conditions of commonly used statistical indicators such as sensitivity, specificity, likelihood ratio and predictive value, etc., as well as the evaluation criteria of Kappa test to evaluate the consistency of the two detection systems. For quantitative products, the criteria of outlier analysis, the application conditions and evaluation criteria of correlation analysis, Bland-Altman method, regression analysis and ROC analysis were introduced. We mainly introduced the principles, interpretation, application conditions and evaluation criteria of the commonly used statistical methods, which can be referred by reviewers of in vitro diagnostic reagents when evaluating registration application materials.