Table 1 CMS CLIA criteria for analytical validation of an LDT
From: Establishing a stable, repeatable platform for measuring changes in sperm DNA methylation
Criteria | Description |
|---|---|
Accuracy | Comparison of the test results to a gold-standard to determine how well it matches quantification or detection of the analyte. |
Precision | Repeatability of the assay. |
Analytical sensitivity | How well the test can detect low levels of the analyte. |
Analytical specificity | How well the test detects the desired analyte and not other closely related contaminants |
Reportable range | Upper and lower limit of levels that can reliably be reported; values outside the reportable range must be reported as either greater than the upper limit or less than the lower limit. |
Reference interval | What is considered a “normal” outcome for the test. |