Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis

Overview

Journal J Clin Diagn Res

Specialty General Medicine

Date 2016 Nov 29

PMID 27891446

Citations 242

Authors

Mohamad Adam Bujang

Tassha Hilda Adnan

Affiliations

Soon will be listed here.

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.

Citing Articles

Systematic review and meta‑analysis of factors predicting postoperative lung function after lung cancer resection.

Wang H, He L, Hu X, Xian G Wideochir Inne Tech Maloinwazyjne. 2025; 19(3):289-298.

PMID: 40041108 PMC: 11867271. DOI: 10.20452/wiitm.2024.17892.

Optimization of Antimicrobial Use for Sepsis in Calves: Bayesian Evaluation of Existing and Novel Sepsis Scores.

Pas M, Bokma J, Boyen F, Chantillon L, Castelain D, Clinquart J Animals (Basel). 2025; 15(4).

PMID: 40003069 PMC: 11851423. DOI: 10.3390/ani15040586.

N-Ammonia PET-CT for Evaluating Response to Antiangiogenic Therapy and Prognosis in Patients with Advanced Hepatocellular Carcinoma: A Pilot Study.

Scolozzi V, Nicoletti A, Capotosti A, Ponziani F, Taralli S, Genco E Cancers (Basel). 2025; 17(4).

PMID: 40002251 PMC: 11853641. DOI: 10.3390/cancers17040656.

Novel Procedures for Evaluating Autism Online in a Culturally Diverse Population of Children: Protocol for a Mixed Methods Pathway Development Study.

Mirzaei V, Wolstencroft J, Lockwood Estrin G, Buckley E, Sayani S, Katakis P JMIR Res Protoc. 2025; 14:e55741.

PMID: 39932780 PMC: 11862771. DOI: 10.2196/55741.

Prevalence and risk factors of under-five mortality due to severe acute malnutrition in Africa: a systematic review and meta-analysis.

Wambua J, Ali A, Ukwizabigira J, Kuodi P Syst Rev. 2025; 14(1):29.

PMID: 39885605 PMC: 11780833. DOI: 10.1186/s13643-024-02740-9.

References

Netzer N, Stoohs R, Netzer C, Clark K, Strohl K . Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999; 131(7):485-91. DOI: 10.7326/0003-4819-131-7-199910050-00002. View

Enoe C, Georgiadis M, Johnson W . Estimation of sensitivity and specificity of diagnostic tests and disease prevalence when the true disease state is unknown. Prev Vet Med. 2000; 45(1-2):61-81. DOI: 10.1016/s0167-5877(00)00117-3. View

Choplin N, Lundy D . The sensitivity and specificity of scanning laser polarimetry in the detection of glaucoma in a clinical setting. Ophthalmology. 2001; 108(5):899-904. DOI: 10.1016/s0161-6420(00)00652-7. View

Baeres M, Herkel J, Czaja A, Wies I, Kanzler S, Cancado E . Establishment of standardised SLA/LP immunoassays: specificity for autoimmune hepatitis, worldwide occurrence, and clinical characteristics. Gut. 2002; 51(2):259-64. PMC: 1773315. DOI: 10.1136/gut.51.2.259. View

Arroll B, Khin N, Kerse N . Screening for depression in primary care with two verbally asked questions: cross sectional study. BMJ. 2003; 327(7424):1144-6. PMC: 261815. DOI: 10.1136/bmj.327.7424.1144. View

Law M, Yang S, Wang H, Babb J, Johnson G, Cha S . Glioma grading: sensitivity, specificity, and predictive values of perfusion MR imaging and proton MR spectroscopic imaging compared with conventional MR imaging. AJNR Am J Neuroradiol. 2003; 24(10):1989-98. PMC: 8148904. View

Nori S, Rius-Diaz F, Cuevas J, Goldgeier M, Jaen P, Torres A . Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: a multicenter study. J Am Acad Dermatol. 2004; 51(6):923-30. DOI: 10.1016/j.jaad.2004.06.028. View

Simel D, Samsa G, Matchar D . Likelihood ratios with confidence: sample size estimation for diagnostic test studies. J Clin Epidemiol. 1991; 44(8):763-70. DOI: 10.1016/0895-4356(91)90128-v. View

Yunus A, Seet W, Mohamad Adam B, Haniff J . Validation of the Malay version of Berlin questionaire to identify Malaysian patients for obstructive sleep apnea. Malays Fam Physician. 2015; 8(1):5-11. PMC: 4170461. View

10.

Erbel R, Engberding R, Daniel W, Roelandt J, Visser C, Rennollet H . Echocardiography in diagnosis of aortic dissection. Lancet. 1989; 1(8636):457-61. DOI: 10.1016/s0140-6736(89)91364-0. View

11.

Senthil M, Salowi M, Bujang M, Kueh A, Siew C, Sumugam K . Risk Factors and Prediction Models for Retinopathy of Prematurity. Malays J Med Sci. 2017; 22(5):57-63. PMC: 5295742. View

12.

Burgess L, Maritz F, le Roux I, Taljaard J . Use of adenosine deaminase as a diagnostic tool for tuberculous pleurisy. Thorax. 1995; 50(6):672-4. PMC: 1021270. DOI: 10.1136/thx.50.6.672. View

13.

Shea J, Berlin J, Escarce J, Clarke J, Kinosian B, Cabana M . Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994; 154(22):2573-81. View

14.

Buderer N . Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996; 3(9):895-900. DOI: 10.1111/j.1553-2712.1996.tb03538.x. View