Table 2.
Difference in agreement rates between manual reads vs. ground truth, and image analysis vs. ground truth.
| MR status |
||||
|---|---|---|---|---|
| GT status | IA status | Amplified | Non-amplified | Total |
| Amplified | Amplified | 309 | 3 | 312 |
| Non-amplified | 2 | 7 | 9 | |
| Total | 311 | 10 | 321 | |
| MR PPA n/N (%) (95% CI) | 311/321(96.9) | (94.2, 99.0) | ||
| IA PPA n/N (%) (95% CI) | 312/321(97.2) | (95.0, 99.3) | ||
| Difference of PPA (IA - MR) n/N (%) (95% CI) | 1/321 (0.3) | (-0.9, 1.8) | ||
| Non-amplified | Amplified | 8 | 11 | 19 |
| Non-amplified | 0 | 312 | 312 | |
| Total | 8 | 323 | 331 | |
| MR NPA n/N (%) (95% CI) | 323/331 (97.6) | (95.8, 99.4) | ||
| IA NPA n/N (%) (95% CI) | 312/331 (94.3) | (90.8, 97.3) | ||
| Difference of NPA (IA - MR) n/N (%) (95% CI) | -11/331 (-3.3) | (-6.2, -1.2) | ||
| Overall | Amplified | 317 | 14 | 331 |
| Non-amplified | 2 | 319 | 321 | |
| Total | 319 | 333 | 652 | |
| MR OPA n/N (%) (95% CI) | 634/652 (97.2) | (95.7, 98.6) | ||
| IA OPA n/N (%) (95% CI) | 624/652 (95.7) | (93.8, 97.5) | ||
| Difference of OPA (IA - MR) n/N (%) (95% CI) | -10/652 (-1.5) | (-3.1, -0.2) | ||
GT ground truth, IA image analysis, MR manual read; PPA positive percent agreement, NPA negative percent agreement, OPA overall percent agreement, CI confidence interval.
Note: 2-sided 95% confidence intervals were calculated using the percentile bootstrap method with cases stratified by the 4 screening bins.
Note: This analysis includes all 3 study Reader Pathologists' results.