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Statistical criteria of TC certification for clinical laboratory.
| Parameter | Criterion |
|---|---|
| r2 | >0.975 |
| Bias at 200 mg/dl | ≤3% |
| Bias at 240 mg/dl | ≤3% |
| Average % bias | ≤3% |
| Average absolute % bias | ≤3% |
| Among-run CV | ≤3% |
| t-test of bias | Not significant at α = 5% |
| Within-method outliers | 1 allowed |
| Between-method outliers | None allowed, but may eliminate one sample |
