Please anyone let me know the statistical way to determine the minimum required sample size when comparing the clinical performance including sensitivity and specificity of diagnostic test kits [more than 2 kits situation].
Dear Prabhath: sample size in any population is a matter of representing that population. It was reported the the minimum acceptable sample size is between 30 to 50 items. This is because that this size will represent the population since we do expect to have a normal distribution in this range of sample size. Regards
Dear Prof.@Medhat, I really thankful for your valuable response. I would be much obliged if you could mention any reference material which can be used when methodology needs to be justified.
Hi,
Here are some references to help you:
Bujang MA, Adnan TH. Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis. J Clin Diagn Res. 2016;10(10):YE01-YE06. doi:10.7860/JCDR/2016/18129.8744
Negida A, Fahim NK, Negida Y. Sample Size Calculation Guide - Part 4: How to Calculate the Sample Size for a Diagnostic Test Accuracy Study based on Sensitivity, Specificity, and the Area Under the ROC Curve. Advanced Journal of Emergency Medicine. 2019 ;3(3):e33. DOI: 10.22114/ajem.v0i0.158
Journal of Biomedical Informatics. Volume 48, April 2014, Pages 193-204
Sample size estimation in diagnostic test studies of biomedical informaticsMethodological Review
Author links open overlay panelKarimollahHajian-Tilaki
https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(19)30163-6/fulltext
Online Diagnostic test calculators:
http://araw.mede.uic.edu/cgi-bin/testcalc.pl
https://epitools.ausvet.com.au/freecalctwo
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