Table 3.
Performance Specifications of the Assay in Clinical Specimens
| Specification | 48 samples | 96 samples | 51 samples |
|---|---|---|---|
| Analytical sensitivity (SNVs and small indels, %; n/N)∗ | 100; 287/287 | 100; 122/122 | 100; 89/89 |
| Analytical sensitivity (TG-polyT tracts, %; n) | 100; 47/47 | 100; 93/93 | 100; 29/29 |
| Sensitivity in reportable range† (%) | 100 | 100 | 100 |
| Analytical specificity (%) | 100 | 100 | 100 |
polyT, poly-thymidine; SNV, single-nucleotide variant; TG, thymidine-guanine.
∗
Variants within the region of interest (ROI) called correctly by next-generation sequencing method/expected variants.
†
% bp within the 13,482-bp ROI that are covered by >100 reads per bp.