Table 1.
Association between blinded visual assessment and Bielschowsky silver stain, thioflavin S, and qualitative overall pathology read—efficacy population
| Reader | Blinded visual assessment | Qualitative Bielschowsky silver stain pathology read | Qualitative thioflavin S pathology read | Qualitative overall pathology read | Sensitivity and specificity | ||||
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| Abnormal (N=2) | Normal (N=3) | Abnormal (N=2) | Normal (N=8) | Abnormal (N=2) | Normal (N=8) | Sensitivity % (95 % CI) | Specificity % (95 % CI) | ||
| Reader 1 | Abnormal | 2 (100) | 0 | 2 (100) | 0 | 2 (100) | 0 | Bielschowsky: 100 (16, 100) Thioflavin S: 100 (16, 100) |
Bielschowsky: 100 (29, 100) Thioflavin S: 100.0 (63, 100) |
| Normal | 0 | 3 (100) | 0 | 8 (100) | 0 | 8 (100) | Overall: 100 (16, 100) | Overall: 100 (63, 100) | |
| Reader 2 | Abnormal | 2 (100) | 0 | 2 (100) | 0 | 2 (100) | 0 | Bielschowsky: 100 (16, 100) Thioflavin S: 100 (16, 96) |
Bielschowsky: 100 (29, 100) Thioflavin S: 100 (63, 100) |
| Normal | 0 | 3 (100) | 0 | 8 (100) | 0 | 8 (100) | Overall: 100 (16, 100) | Overall: 100 (63, 100) | |
| Reader 3 | Abnormal | 2 (100) | 0 | 2 (100) | 0 | 2 (100) | 0 | Bielschowsky: 100 (16, 100) Thioflavin S: 100 (16, 100) |
Bielschowsky: 100 (29, 100) Thioflavin S: 100 (63, 100) |
| Normal | 0 | 3 (100) | 0 | 8 (100) | 0 | 8 (100) | Overall: 100 (16, 100) | Overall:100 (63, 100) | |
| Majority read | Abnormal | 2 (100) | 0 | 2 (100) | 0 | 2 (100) | 0 | Bielschowsky: 100 (16, 100) Thioflavin S: 67 (22, 96) |
Bielschowsky: 100 (29, 100) Thioflavin S: 100 (66, 100) |
| Normal | 0 | 3 (100) | 0) | 8 (100) | 0 | 8 (100) | Overall: 100 (40, 100) | Overall: 100 (72, 100) | |