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

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

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.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bacteriological Techniques / methods*
  • Bias
  • Humans
  • Product Labeling*
  • Tuberculosis / diagnosis*
  • United States
  • United States Food and Drug Administration
  • World Health Organization