TABLE 4.
Overall concordance analysis of p.T790 M mutation status between liquid specimens and matched tumor samples that are classified by sputum cytological evaluation
| Malignant sputum N = 8 | Liquid specimens (sputum cfDNA) | ||||||
|---|---|---|---|---|---|---|---|
| p.T790 M Mutation | Positive | Negative | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV% (95% CI) | |
| Matched tumor sample | Positive | 4 | 0 | 100% (39.6%, 100%) | 100% (39.6%, 100%) | 100% (39.6%, 100%) | 100% (39.6%, 100%) |
| Negative | 0 | 4 | |||||
| Satisfactory but no malignant cells sputum N = 10 | Liquid specimens (sputum cfDNA +plasma cfDNA) | ||||||
| p.T790 M Mutation | Positive | Negative | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | |
| Matched tumor sample | Positive | 3 | 0 | 100% (31.0%, 100%) | 100% (56.1%, 100%) | 100% (31.0%, 100%) | 100% (56.1%, 100%) |
| Negative | 0 | 7 | |||||
| Unsatisfactory sputum N = 3 | Liquid specimens (plasma cfDNA) a | ||||||
| p.T790 M Mutation | Positive | Negative | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | |
| Matched tumor sample | Positive | 1 | 1 | 50% (2.7%, 97.3%) | 100% (5.5%, 100%) | 100% (5.5%, 100%) | 50% (2.7%, 97.3%) |
| Negative | 0 | 1 | |||||
a
The plasma samples of two cases were unavailable.