Table 2.
Comparison of regulatory requirement among CLSI, LDTS, and TAF for analytical performance in developing a LC-MS assay. TFDA-LDTS: Taiwan Food and Drug Administration; TAF: Taiwan Accreditation Foundation; CLSI: Clinical & Laboratory Standards Institute
| Item | TFDA-LDTS | TAF-CNLA-G38 | CLSI-C64Ed1E | |
|---|---|---|---|---|
| I | Tracebility | ⌾ | ||
| II | Accuracy | ⌾ | ⌾ | 8.10 |
| Trueness (bias) | ⌾ | 8.10 | ||
| Method comparison | 8.10 | |||
| Patient comparison | ||||
| III | Precision | ⌾ | ⌾ | 8.2 |
| Reproducibility | ⌾ | ⌾ | 8.2 | |
| Repeatability | ⌾ | |||
| Measurement uncertainty | ⌾ | |||
| IV | Reportable range | ⌾ | ||
| Linearity interval | ⌾ | 8.4.1 | ||
| Measuting interval | ⌾ | |||
| Dilution verification | 8.4.2 | |||
| V | Sensitivity | ⌾ | ⌾ | 8.3 |
| Cut-off value | ⌾ | 8.12 | ||
| Limit of detection (LOD) | ⌾ | |||
| Limit of quantitation (LOQ) | ⌾ | |||
| Carry over | 8.8 | |||
| VI | Specificity | ⌾ | ⌾ | 8.7 |
| Interfering substances | ⌾ | 8.7 | ||
| Matrix effects | ⌾ | 8.7 | ||
| Matrix comparison | 8.11 | |||
| VII | Stability | ⌾ | 8.5/8.6 | |
| Ion transition ratios | 8.9 | |||
| Ruggedness | ⌾ | 8.13.1 | ||
| Reagent lot changes | 8.13.2 |