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Review
. 2016 Oct;10(10):YE01-YE06.
doi: 10.7860/JCDR/2016/18129.8744. Epub 2016 Oct 1.

Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis

Mohamad Adam Bujang  1 , Tassha Hilda Adnan  1
Affiliations
Review

Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis

Mohamad Adam Bujang et al. J Clin Diagn Res. 2016 Oct.

Abstract

Sensitivity and specificity analysis is commonly used for screening and diagnostic tests. The main issue researchers face is to determine the sufficient sample sizes that are related with screening and diagnostic studies. Although the formula for sample size calculation is available but concerning majority of the researchers are not mathematicians or statisticians, hence, sample size calculation might not be easy for them. This review paper provides sample size tables with regards to sensitivity and specificity analysis. These tables were derived from formulation of sensitivity and specificity test using Power Analysis and Sample Size (PASS) software based on desired type I error, power and effect size. The approaches on how to use the tables were also discussed.

Keywords: Diagnostic; Screening; Type I error.

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Figures

[Table/Fig-1]:
[Table/Fig-1]:
Sample size calculation for sensitivity and specificity analysis for prevalence of disease from 5% to 20%.  Prev = prevalence of disease  Ho = Hypothesis null  Ha = Hypothesis alternative N1 = The minimum number of sample size for positive disease  N = The minimum number of sample size requirement for total
[Table/Fig-2]:
[Table/Fig-2]:
Sample size calculation for sensitivity and specificity analysis for prevalence of disease from 30% to 60%. Prev = prevalence of disease  Ho = Hypothesis null  Ha = Hypothesis alternative N1 = The minimum number of sample size for positive disease  N = The minimum number of sample size requirement for total
[Table/Fig-3]:
[Table/Fig-3]:
Sample size calculation for sensitivity and specificity analysis for prevalence of disease from 70% to 90%. Prev = prevalence of disease  Ho = Hypothesis null  Ha = Hypothesis alternative  N1 = The minimum number of sample size for positive disease  N = The minimum number of sample size requirement for total
See this image and copyright information in PMC

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