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Meta-Analysis
. 2012 Jul;50(7):2455-61.
doi: 10.1128/JCM.00842-12. Epub 2012 May 9.

Promise versus reality: optimism bias in package inserts for tuberculosis diagnostics

Claudia M Denkinger  1 , Jasmine Grenier, Jessica Minion, Madhukar Pai
Affiliations
Meta-Analysis

Promise versus reality: optimism bias in package inserts for tuberculosis diagnostics

Claudia M Denkinger et al. J Clin Microbiol. 2012 Jul.

Abstract

Laboratorians and clinicians often rely on package inserts of diagnostic tests to assess their accuracy. We compared test accuracy for tuberculosis diagnostics reported in 19 package inserts against estimates in published meta-analyses and found that package inserts generally report overoptimistic accuracy estimates. However, package inserts of most tests approved by the U.S. Food and Drug Administration (FDA) or endorsed by the World Health Organization provide more realistic estimates that agree with meta-analyses.

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