Characteristics of assay analytical performance and statistical analyses for evaluating test(s) accuracy
| Characteristics . |
|---|
| Specimen and analytical performance characteristics |
| • Specimen stability with freeze/thaw |
| • Specimen type and matrix complexity (undiluted plasma/serum may have circulating antibodies that can cross-react with the specific antibodies) |
| • Assay specificity (interference, cross-reactivity) |
| • Assay sensitivity (lower limit of detection) |
| • Assay range |
| • Precision within runs and between runs |
| • Accuracy: Recovery of spiked analyte is within 75%-125% at all ranges |
| Analysis for test(s) accuracy evaluation |
| • Sensitivity: Proportion of subjects in a sample of patients with the target condition in whom the test is positive |
| • Specificity: Proportion of subjects in a sample of patients without the target condition in whom the test is negative |
| • Receiver operator characteristic curve: A plot of the true-positive rate vs the false-positive rate for all possible cut points of a biomarker |
| • Positive predictive value: Proportion of patients in the overall population with a positive test who have the target condition |
| • Negative predictive value: Proportion of patients in the overall population with a negative test who do not have the target condition |
| Characteristics . |
|---|
| Specimen and analytical performance characteristics |
| • Specimen stability with freeze/thaw |
| • Specimen type and matrix complexity (undiluted plasma/serum may have circulating antibodies that can cross-react with the specific antibodies) |
| • Assay specificity (interference, cross-reactivity) |
| • Assay sensitivity (lower limit of detection) |
| • Assay range |
| • Precision within runs and between runs |
| • Accuracy: Recovery of spiked analyte is within 75%-125% at all ranges |
| Analysis for test(s) accuracy evaluation |
| • Sensitivity: Proportion of subjects in a sample of patients with the target condition in whom the test is positive |
| • Specificity: Proportion of subjects in a sample of patients without the target condition in whom the test is negative |
| • Receiver operator characteristic curve: A plot of the true-positive rate vs the false-positive rate for all possible cut points of a biomarker |
| • Positive predictive value: Proportion of patients in the overall population with a positive test who have the target condition |
| • Negative predictive value: Proportion of patients in the overall population with a negative test who do not have the target condition |