TABLE 3.
Assay | Screening assay result | Whole genome sequencing result |
Assay clinical analysis |
||||||
---|---|---|---|---|---|---|---|---|---|
Reference | Substitution | Alternate | % Accuracy | % Clinical sensitivity | % Clinical specificity | % PPV | % NPV | ||
K417T | Reference | 176 | 0 | 0 | 99.20 [98.10, 100.0a] | 97.30 [93.55, 100.0] | 100.0 [100.0] | 100.0 [100.0] | 98.88 [97.33, 100.0] |
Substitution | 0 | 64 | 0 | ||||||
Inconclusive | 2 | 0 | 8 | ||||||
E484K | Reference | 173 | 0 | 0 | 96.40 [94.09, 98.71] | 88.31 [80.67, 95.95] | 100.0 [100.0] | 100.0 [100.0] | 95.05 [91.90, 98.20] |
Substitution | 0 | 68 | 0 | ||||||
Inconclusive | 2 | 7 | 0 | ||||||
E484Q | Reference | 179 | 0 | 0 | 99.60 [98.88, 100.0] | 98.59 [95.83, 100.0] | 100.0 [100.0] | 100.0 [100.0] | 99.44 [98.35, 100.0] |
Substitution | 0 | 0 | 0 | ||||||
Inconclusive | 1 | 0 | 70 | ||||||
L452R | Reference | 181 | 2 | 0 | 96.80 [94.62, 98.98] | 88.41 [80.38, 96.47] | 100.0 [100.0] | 100.0 [100.0] | 95.77 [92.90, 98.64] |
Substitution | 0 | 61 | 0 | ||||||
Inconclusive | 4 | 2 | 0 |
Upper-bound value cannot exceed 100.0%. This applies to all measurements. 95% confidence interval is represented in brackets.