Peer-reviewed veterinary case report
Differentiating between analytical and diagnostic performance evaluation with a focus on the method comparison study and identification of bias.
- Journal:
- Veterinary clinical pathology
- Year:
- 2014
- Authors:
- Flatland, Bente et al.
- Affiliation:
- Department of Biomedical and Diagnostic Sciences · United States
Plain-English summary
Before a new testing method is used in a veterinary lab, it needs to be checked to make sure it works correctly according to the manufacturer's guidelines. This involves two main steps: first, confirming that the method performs accurately compared to an established test, and second, ensuring it can correctly identify sick animals versus healthy ones. The first step looks for any inaccuracies in the new test compared to the old one, while the second step evaluates how well the test can detect specific diseases. It's important to complete the first step before moving on to the second, and sometimes the second step isn't necessary for tests that are already well-known or not specific to a particular illness. This review aims to clarify these two types of evaluations and discuss how to assess any inaccuracies in the new testing methods.
Abstract
Prior to introduction of a new method to the diagnostic laboratory, analytical performance must be validated to ensure operation within the manufacturer's specifications and/or within predetermined quality requirements. In addition, the new method may require diagnostic performance assessment to ensure it differentiates between diseased and nondiseased individuals as intended. These 2 phases of assessment, while complementary, are not equivalent and require a different set of experiments, statistical analyses, and interpretation. Studies of analytical performance typically include a method comparison experiment, the purpose of which is to identify bias (inaccuracy) of the "test" (or "index") method (new method) relative to a "comparative method" (established method). Analysis of method comparison data is facilitated by commercial software programs that present the statistical significance of identified bias; however, the clinical relevance of any bias also should be considered. Studies of diagnostic performance should not be pursued until analytical performance is fully characterized and may not be required for well-established tests or for those for which results are nonspecific (ie, not referable to a specific disease or condition). Diagnostic performance assessment may include assessment of sensitivity, specificity, predictive values, odds ratios, and/or likelihood ratios. The purpose of this review is to clarify differences between the assessment of analytical and diagnostic performance, and to explore the method comparison study and bias assessment from a perspective not addressed in prior veterinary articles.
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Search related cases →Original publication: https://pubmed.ncbi.nlm.nih.gov/25257670/