Table 2.
Performance of detecting TERT promotor mutation in the pre-diagnostic urine samples as an early detection biomarker for bladder cancer.
| Statistics | Urinary DNA (N = 131) | 95% CI |
|---|---|---|
| All Pre-diagnostic samples | ||
| True Positive (n) | 14 | – |
| True Negative (n) | 101 | – |
| False positive (n) | 0 | – |
| False negative (n) | 16 | – |
| Sensitivity (%) | 46·67 | 28·34 – 65·67 |
| Specificity (%) | 100·00 | 96·41 – 100·00 |
| Positive likelihood ratio (%) | – | – |
| Negative likelihood ratio (%) | 0·53 | 0·38 – 0·75 |
| Positive predictive value (%)a | 100·00 | |
| Negative predictive value (%)a | 99·95 | 99·93 – 99·97 |
| Accuracy (%) | 99·96 | 99·94 – 99·97 |
| < 7 years prior diagnosisb | ||
| True Positive (n) | 08 | – |
| False Negative (n) | 06 | – |
| Sensitivity (%) | 57·14 | 28·86 – 82·34 |
| > 7 years prior diagnosisb | ||
| True Positive (n) | 06 | – |
| False Negative (n) | 10 | – |
| Sensitivity (%) | 37·50 | 15·20 – 64·57 |
| Non-Muscle Invasive Bladder Cancer | ||
| True Positive (n) | 03 | – |
| False Negative (n) | 06 | – |
| Sensitivity (%) | 33·33 | 7·49 – 70·07 |
| Muscle Invasive Bladder Cancer | ||
| True Positive (n) | 10 | – |
| False Negative (n) | 06 | – |
| Sensitivity (%) | 62·50 | 35·43 – 84·80 |
CI: Confidence Interval.
a
Positive and negative predictive values were calculated using the prevalence of bladder cancer (0·09%) in the Golestan population based cohort.
b
Median time to BC diagnosis.