Table 2.
Single-Site and Multisite Precision
| Target MR | Mean MR | SD | Target %IS | Mean %IS | % CV | N |
|---|---|---|---|---|---|---|
| Single-site precision | ||||||
| 1 | 0.70 | 0.08 | 10 | 20.3613 | 16.6 | 40 |
| 2 | 1.63 | 0.08 | 1 | 2.3423 | 11.7 | 40 |
| 3 | 2.66 | 0.08 | 0.1 | 0.2211 | 11.0 | 40 |
| 3.5 | 3.18 | 0.10 | 0.032 | 0.0663 | 16.8 | 40 |
| 4 | 3.68 | 0.13 | 0.01 | 0.0215 | 18.9 | 40 |
| Multisite precision | ||||||
| 1 | 0.74 | 0.06 | 10 | 18.1906 | 13.7 | 240 |
| 2 | 1.69 | 0.07 | 1 | 2.0787 | 15.8 | 240 |
| 3 | 2.70 | 0.09 | 0.1 | 0.2031 | 20.9 | 240 |
| 3.5 | 3.22 | 0.13 | 0.032 | 0.0628 | 29.4 | 240 |
| 4 | 3.72 | 0.13 | 0.01 | 0.0197 | 29.9 | 240 |
The precision of the assay was evaluated with both single-site and multisite studies by testing five separate dilution series across five target MR values. Data herein were combined per target MR level. SD values of MR measurements formed the definitive acceptance criteria. %IS values are shown for historical reference. Supplemental Tables S1 and S2 detail each specimen and source of variation separately.
IS, international scale; MR, molecular response.