Key concepts and limitations of statistical methods for evaluating biomarkers of kidney disease

J Am Soc Nephrol. 2014 Aug;25(8):1621-9. doi: 10.1681/ASN.2013121300. Epub 2014 May 1.


Interest in developing and using novel markers of kidney injury is increasing. To maintain scientific rigour in these endeavors, a comprehensive understanding of statistical methodology is required to rigorously assess the incremental value of novel biomarkers in existing clinical risk prediction models. Such knowledge is especially relevant, because no single statistical method is sufficient to evaluate a novel biomarker. In this review, we highlight the strengths and limitations of various traditional and novel statistical methods used in the literature for biomarker studies and use biomarkers of AKI as examples to show limitations of some popular statistical methods.

Keywords: NRI; biomarker; c index.

Publication types

  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Area Under Curve
  • Biomarkers*
  • Decision Support Techniques
  • Humans
  • Kidney Diseases / diagnosis*
  • Kidney Diseases / etiology
  • Odds Ratio
  • Predictive Value of Tests
  • ROC Curve
  • Reproducibility of Results
  • Risk


  • Biomarkers