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Table 1 Description of the simulation setting assumptions made based on the Target Product Profiles (TPPs), where Dmin corresponds to the scenario where the minimum number of cases were correctly detected to satisfy the desirable TPP and Amin corresponds to the scenario where the minimum number of cases were correctly detected to satisfy the acceptable TPP

From: Examining the effect of evaluation sample size on the sensitivity and specificity of COVID-19 diagnostic tests in practice: a simulation study

Setting

Setting 1 (Dmin)

Setting 2 (Amin)

N (simulation population size)

5,000

5,000

Iterations

10,000

10,000

Evaluation performance assumption

Equal to desirable characteristics (97% sensitivity and 99% specificity)

Equal to acceptable characteristics (80% sensitivity and 95% specificity)

Failure criterion

less than the lower bound of 95% confidence interval (93% sensitivity and 97% specificity)

less than the lower bound of 95% confidence interval (70% sensitivity and 90% specificity)