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 |