How It Works
Study Design
The MIMC module requires each specimen to be measured on all instruments included in the study, enabling direct cross-instrument comparison at the same concentration. The minimum recommended design is:
Multi-Instrument Method ComparisonVerificationCLSI EP31-A-IR2–30 instruments
| Instruments | 2–30 (minimum 2; one may be designated as target) |
| Specimens | Minimum 3; 5–10 recommended |
| Replicates per specimen | Minimum 1 per specimen per day |
| Days | Multiple days recommended to assess reproducibility |
| Concentration range | Specimens should span the reportable range |
| Paired observations | Minimum 3 paired observations required |
All instruments must measure the same specimens to enable direct comparison. Concentrations should be distributed across the reportable range — not clustered at a single level — to evaluate agreement across clinically relevant values.