Table. 2.
Required performance characteristics during the test performance verification process
| Accuracy | Precision | Reportable range (AMR) | Linearity | Analytic specificity (interferences) | Limit of detection | Reference interval | |
|---|---|---|---|---|---|---|---|
| CLIA [10] | Verify | Verify | Verify | Verify | |||
| CAP [11] | Verify | Verify | Verify; literature or manufacturer documentation OK | Verify | Verify; literature or manufacturer documentation OK | Verify | Verify; literature or manufac- turer documentation OK |
| AMP [4] | Verify | Verify | Verify | Verify | |||
| EGVG [12] | Verify | Verify | Verify |
Abbreviations: AMR, analytical measurement range; CLIA, Clinical Laboratory Improvement Amendment; CAP, College of American Pathologists; AMP, Association for Molecular Pathology; EGVG, EuroGentest Validation Group.
Lab Med Online 2022;12:227~234 https://doi.org/10.47429/lmo.2022.12.4.227
© Lab Med Online