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Methods and recommendations for evaluating and reporting a new diagnostic test

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Abstract

No standardized guidelines exist for the biostatistical methods appropriate for studies evaluating diagnostic tests. Publication recommendations such as the STARD statement provide guidance for the analysis of data, but biostatistical advice is minimal and application is inconsistent. This article aims to provide a self-contained, accessible resource on the biostatistical aspects of study design and reporting for investigators. For all dichotomous diagnostic tests, estimates of sensitivity and specificity should be reported with confidence intervals. Power calculations are strongly recommended to ensure that investigators achieve desired levels of precision. In the absence of a gold standard reference test, the composite reference standard method is recommended for improving estimates of the sensitivity and specificity of the test under evaluation.

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Acknowledgments

MS’s work on this article was supported by NIH grant 1K25AG034216.

ADH’s work on this article was supported by NIH grant 1K24AI079040-01A1.

Conflict of interest

JKJ has received funding from Becton Dickinson. The other authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. University of Maryland School of Medicine, Baltimore, MD, USA

    A. S. Hess, M. Shardell, J. K. Johnson, K. A. Thom, P. Strassle, G. Netzer & A. D. Harris

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  1. A. S. Hess
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  2. M. Shardell
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  3. J. K. Johnson
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  4. K. A. Thom
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  5. P. Strassle
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  6. G. Netzer
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  7. A. D. Harris
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Correspondence to A. S. Hess.

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Hess, A.S., Shardell, M., Johnson, J.K. et al. Methods and recommendations for evaluating and reporting a new diagnostic test. Eur J Clin Microbiol Infect Dis 31, 2111–2116 (2012). https://doi.org/10.1007/s10096-012-1602-1

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  • DOI: https://doi.org/10.1007/s10096-012-1602-1

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