Table 2 Dmin scenario estimated mean and 95% confidence intervals of the sensitivity and specificity and the proportion that failed to meet the lower bound of the desirable TPP criteria confidence interval (sensitivity 93%; specificity 97%) assuming the test achieved minimum performance for the desirable TPP (Dmin: 97% sensitivity and 99% specificity) in the evaluation sample, for a simulated population size of 5,000
Evaluation sample size | Observed TP/TN in evaluation | Theoretical | Simulation | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Prevalence: 1% | Prevalence: 5% | Prevalence: 10% | Prevalence: 15% | ||||||||||||||||||
Mean | 95% CI | Failure (%) | Mean | 95% CI | Failure (%) | Mean | 95% CI | Failure (%) | Mean | 95% CI | Failure (%) | Mean | 95% CI | Failure (%) | |||||||
Sensitivity | |||||||||||||||||||||
30 | 30 | 96.9% | 88.8% | 99.9% | 10.5% | 96.9% | 86.5% | 100.0% | 13.5% | 96.9% | 88.5% | 100.0% | 11.3% | 96.9% | 88.5% | 100.0% | 10.7% | 96.9% | 88.5% | 100.0% | 11.1% |
50 | 49 | 96.2% | 89.6% | 99.5% | 11.9% | 96.2% | 86.8% | 100.0% | 17.7% | 96.1% | 88.8% | 100.0% | 14.0% | 96.1% | 89.3% | 99.6% | 13.2% | 96.2% | 89.3% | 99.6% | 12.4% |
100 | 97 | 96.1% | 91.6% | 98.9% | 7.1% | 96.1% | 87.8% | 100.0% | 17.2% | 96.0% | 90.6% | 99.5% | 10.3% | 96.1% | 91.2% | 99.2% | 8.6% | 96.1% | 91.3% | 99.1% | 8.1% |
150 | 146 | 96.7% | 93.4% | 98.9% | 1.7% | 96.8% | 89.8% | 100.0% | 10.7% | 96.7% | 92.5% | 99.6% | 3.7% | 96.7% | 92.8% | 99.2% | 2.9% | 96.7% | 93.1% | 99.1% | 2.3% |
200 | 194 | 96.5% | 93.6% | 98.6% | 1.1% | 96.5% | 89.6% | 100.0% | 12.1% | 96.5% | 92.7% | 99.2% | 3.5% | 96.5% | 93.0% | 99.0% | 2.6% | 96.5% | 93.3% | 98.8% | 1.8% |
250 | 243 | 96.8% | 94.3% | 98.6% | 0.3% | 96.8% | 90.4% | 100.0% | 9.6% | 96.8% | 93.1% | 99.2% | 2.3% | 96.8% | 93.7% | 99.0% | 0.9% | 96.8% | 93.9% | 98.9% | 0.6% |
500 | 485 | 96.8% | 95.1% | 98.2% | 0.0% | 96.8% | 90.7% | 100.0% | 8.4% | 96.8% | 93.8% | 99.2% | 0.8% | 96.8% | 94.3% | 98.8% | 0.2% | 96.8% | 94.6% | 98.6% | 0.1% |
1000 | 970 | 96.9% | 95.7% | 97.9% | 0.0% | 96.9% | 91.1% | 100.0% | 7.5% | 96.9% | 94.3% | 99.1% | 0.3% | 96.9% | 94.9% | 98.6% | 0.0% | 96.9% | 95.1% | 98.4% | 0.0% |
2000 | 1940 | 97.0% | 96.2% | 97.7% | 0.0% | 97.0% | 91.4% | 100.0% | 6.9% | 97.0% | 94.4% | 98.9% | 0.2% | 96.9% | 95.1% | 98.5% | 0.0% | 97.0% | 95.4% | 98.3% | 0.0% |
Specificity | |||||||||||||||||||||
30 | 30 | 96.9% | 88.8% | 99.9% | 38.9% | 96.9% | 88.8% | 99.9% | 39.5% | 96.9% | 89.1% | 99.9% | 38.7% | 96.9% | 88.9% | 99.9% | 39.1% | 96.9% | 88.8% | 99.9% | 39.5% |
50 | 50 | 98.1% | 93.0% | 100.0% | 21.2% | 98.1% | 93.1% | 100.0% | 20.1% | 98.1% | 93.1% | 100.0% | 21.7% | 98.1% | 92.9% | 100.0% | 21.5% | 98.1% | 93.0% | 100.0% | 20.7% |
100 | 99 | 98.0% | 94.6% | 99.8% | 19.0% | 98.0% | 94.5% | 99.8% | 19.4% | 98.0% | 94.7% | 99.8% | 19.1% | 98.1% | 94.5% | 99.8% | 18.5% | 98.0% | 94.5% | 99.8% | 18.9% |
150 | 149 | 98.7% | 96.4% | 99.8% | 5.7% | 98.7% | 96.4% | 99.9% | 5.6% | 98.7% | 96.4% | 99.9% | 5.8% | 98.7% | 96.4% | 99.9% | 6.1% | 98.7% | 96.3% | 99.9% | 5.7% |
200 | 198 | 98.5% | 96.5% | 99.7% | 5.8% | 98.5% | 96.4% | 99.7% | 6.3% | 98.5% | 96.4% | 99.7% | 6.4% | 98.5% | 96.4% | 99.7% | 6.0% | 98.5% | 96.4% | 99.7% | 6.3% |
250 | 248 | 98.8% | 97.2% | 99.8% | 1.9% | 98.8% | 97.1% | 99.8% | 2.1% | 98.8% | 97.1% | 99.8% | 2.2% | 98.8% | 97.1% | 99.8% | 2.0% | 98.8% | 97.1% | 99.8% | 2.3% |
500 | 495 | 98.8% | 97.7% | 99.6% | 0.2% | 98.8% | 97.6% | 99.6% | 0.3% | 98.8% | 97.6% | 99.6% | 0.3% | 98.8% | 97.7% | 99.6% | 0.3% | 98.8% | 97.6% | 99.6% | 0.4% |
1000 | 990 | 98.9% | 98.2% | 99.5% | 0.0% | 98.9% | 98.1% | 99.5% | 0.0% | 98.9% | 98.1% | 99.5% | 0.0% | 98.9% | 98.1% | 99.5% | 0.0% | 98.9% | 98.1% | 99.5% | 0.0% |
2000 | 1980 | 99.0% | 98.5% | 99.3% | 0.0% | 98.9% | 98.3% | 99.4% | 0.0% | 98.9% | 98.4% | 99.4% | 0.0% | 98.9% | 98.4% | 99.4% | 0.0% | 99.0% | 98.3% | 99.4% | 0.0% |