Related Experiment Video
Updated: May 23, 2026

Signal Acquisition, Score Interpretation, and Economics of a Non-Invasive Point-of-Care Test for Coronary Artery Disease
Published on: August 9, 2024
Methods and recommendations for evaluating and reporting a new diagnostic test
A S Hess1, M Shardell, J K Johnson
1University of Maryland School of Medicine, Baltimore, MD, USA. ahess@epi.umaryland.edu
Abstract:
No standardized guidelines exist for the biostatistical methods appropriate for studies evaluating diagnostic tests. Publication recommendations such as the STARD statement provide guidance for the analysis of data, but biostatistical advice is minimal and application is inconsistent. This article aims to provide a self-contained, accessible resource on the biostatistical aspects of study design and reporting for investigators. For all dichotomous diagnostic tests, estimates of sensitivity and specificity should be reported with confidence intervals. Power calculations are strongly recommended to ensure that investigators achieve desired levels of precision. In the absence of a gold standard reference test, the composite reference standard method is recommended for improving estimates of the sensitivity and specificity of the test under evaluation.
Related Concept Videos
Sensitivity, Specificity, and Predicted Value
Sensitivity is the...
Automated Microbial Diagnostics
Pulmonary Tuberculosis IV
Several diagnostic approaches are used to detect TB. The conventional method is the Tuberculin Skin Test (TST), also known as the Mantoux test. However, this method has...
Decision Making: Traditional Method
First, a specific claim about the population parameter is decided based on the research question and is stated in a simple form. Further, an opposing statement to this claim is also stated. These statements can act as null and alternative hypotheses, out of which a null hypothesis would be a...
Receiver Operating Characteristic Plot
Therapeutic Drug Monitoring: Drug Analysis Methods

