Performance characteristics that laboratories should consider for verifying and adopting quantitative molecular genetic tests
Characteristics | Definition |
---|---|
Accuracy | The closeness of agreement between a test result and the true value of the analyte |
Precision | The closeness of agreement between independent test results obtained under prescribed conditions |
Linearity | The range where the test values are proportional to the concentration of the analyte in the sample |
Reportable range | The span of test result values over which the laboratory can establish or verify the accuracy of the instrument or test system measurement response |
Limit of detection | The lowest concentration of analyte that the assay can consistently detect with acceptable precision |
Reference intervals | The range of test values expected for a normal or healthy population |