Validation
FF | NGS ASSAY TECHNICAL SPECIFICATIONS
| ACCURACY | SENSITIVITY | SPECIFICITY | LIMIT OF DETECTION | |
|---|---|---|---|---|
| Single nucleotide variants (SNV) | 98.5% | 100.0% | 98.4% | ≥5% VAF and / or ≥20% purity |
| Insertions and deletions (INDELS) | 99.9% | 100.0% | 99.9% | ≥10% VAF and / or ≥20% purity |
| Copy number alterations >1 fold | 96.3% | 93.8% | 99.1% | ≥30% purity |
| Copy number alterations >2 fold | 99.1% | 100.0% | 99.1% | >10% purity |
| ACCURACY | PRECISION (CV) | LIMIT OF DETECTION | |
|---|---|---|---|
| Tumor mutational burden | >98% | <4% | ≥20% purity |
| ACCURACY | PRECISION | LIMIT OF DETECTION | |
|---|---|---|---|
| Microsatellite instability status | 100% | 100% | ≥20% purity |
| ACCURACY | SENSITIVITY | SPECIFICITY | LIMIT OF DETECTION | |
|---|---|---|---|---|
| Fusions (PolyA) | >99% | 96% | >99% | ≥0.1 FFPM (fusion fragments per million) |
| ACCURACY | PRECISION (CV) | LIMIT OF DETECTION | |
|---|---|---|---|
| Gene expressions (PolyA) | >99.6% | 5.06% | ≥ 1.0 TPM (transcripts per million) |