Description

Negida et al reported a sample size calculation for a study of diagnostic test accuracy based on sensitivity and specificity.


Situation: determining accuracy of a diagnostic test

 

Parameters:

(1) sensitivity

(2) specificity

(3) prevalence in population (p)

 

Assumptions:

(1) 95% confidence interval for the normal distribution, with Z value of 1.96

(2) maximum acceptable width (W) set to 10%

(3) p value set to 0.05

 

TP + FN =

= Z^2 * (sensitivity) * (1 - (sensitivity)) / W^2

 

TN + FP =

= Z^2 * (specificity) * (1 - (specificity)) / W^2

 

sample size required for sensitivity =

= (TP + FN) / (p value)

 

sample size required for specificity =

= (TN + FP) / (1 - (p value))

 

total required sample size =

= (sample size for sensitivity) + (sample size for specificity)


To read more or access our algorithms and calculators, please log in or register.