Fig. 2
Dmin scenario estimates of diagnostic performance from a series of Monte Carlo simulations per evaluation sample size. Each simulation consisted of 10,000 iterations each consisting of 5,000 individuals. Here the diagnostic test was assumed to be greater than or equal to the performance for the desirable MHRA TPP with 97% sensitivity and 99% specificity in the evaluation sample. The 95% confidence intervals are displayed for sensitivity and specificity per initial evaluation sample size across different prevalence scenarios. The simulation was considered to have met the TPP confidence interval criterion if the diagnostic characteristic was above the lower bound of the 95% CI specified in the TPP (93% sensitivity and 97% specificity)