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J Clin Diagn Res. 2016 Oct;10(10):YE01-YE06. Epub 2016 Oct 1.

Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis.

Author information

1
Biostatistics Unit, National Clinical Research Centre , Ministry of Health, Malaysia .

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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