Evaluation of binary diagnostic tests accuracy for medical researches

Abstract

Abstract Objectives The aim of this study is to introduce the features of diagnostic tests. In addition, it will be demonstrated which performance measures can be used for diagnostic tests with binary results, the properties of these measures and how to interpret them. Materials and Methods The evaluation of the diagnostic test performance measures may differ depending on whether the test result is numerical or binary. When the diagnostic test result is continuous numerical data, ROC analysis is often utilized. The performance of a diagnostic test with binary results are usually evaluated using the measures of sensitivity and specificity. However, there are some important measures other than these two measures for binary test results. These measures are predictive values, overall accuracy, diagnostic odds ratio, Youden index, and likelihood ratios. Results A hypothetical data has been produced based on the studies conducted on the performance of rapid tests (Specific IgM/IgG) according to the RT-PCR test for Covid 19 in the literature. An example of a diagnostic test (Specific IgM/IgG) with a binary result is given and all measurements and their confidence interval are obtained for this data. The performance of rapid test was examined and interpreted. Conclusion It is important to design and evaluate the performance of diagnostic/screening tests for health care. In this review, some basic definitions, performance measures that can be used only in evaluating the diagnostic tests with binary results and their confidence intervals are mentioned. Having many different measures provides different interpretations in the evaluation of test performance. Accurately predicting the performance of a diagnostic test depends on many factors. These factors can be study design, criteria of participant selection, sample size calculation, test methods etc. There are guidelines that ensure that all information regarding the conditions under which the study was conducted is in report, in terms of such factors. Therefore, these guidelines are recommended for use of the checklist by many publishers.