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Evaluation of diagnostic tests for infectious diseases: general principles

Nature Reviews Microbiology volume 5, pages S21–S31 (2007)Cite this article

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The TDR Diagnostics Evaluation Expert Panel

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Figure 1: Essential elements in designing diagnostic test evaluations.

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  • 27 March 2018

    This article was initially published with an incorrect DOI. A new DOI has been assigned and registered at Crossref, and has been corrected in the article.

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Acknowledgements

We wish to thank Izabela Suder-Dayao for excellent secretarial support, and Robert Ridley and Giorgio Roscigno for support and guidance.

Author information

Author notes

  1. Copyright © WHO, on behalf of TDR (WHO/TDR) 2006

Authors and Affiliations

  1. Shabir Banoo is at the Medicines Control Council of South Africa, Pretoria, South Africa.,

    Shabir Banoo

  2. David Bell is at the Malaria and other Vector-borne and Parasitic Diseases, World Health Organization–Regional Office for the Western Pacific, Manila, Philippines.,

    David Bell

  3. Patrick Bossuyt is at the Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.,

    Patrick Bossuyt

  4. Alan Herring is at the Veterinary School, University of Bristol, Bristol, UK.,

    Alan Herring

  5. David Mabey is at the Clinical Research Unit, London School of Hygiene and Tropical Medicine, London, UK.,

    David Mabey

  6. Freddie Poole is at the Division of Microbiology Devices, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, USA.,

    Freddie Poole

  7. Peter G. Smith is at the Infectious Diseases Epidemiology Unit, London School of Hygiene and Tropical Medicine, London, UK.,

    Peter G Smith

  8. N. Sriram is at the Tulip Group of Companies, Goa, India.,

    N. Sriram

  9. Chansuda Wongsrichanalai is at the US Naval Medical Research Unit 2, Jakarta, Indonesia.,

    Chansuda Wongsrichanalai

  10. Ralf Linke, Rick O'Brien and Mark Perkins are all at the Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland.,

    Ralf Linke, Rick O'Brien & Mark Perkins

  11. Jane Cunningham, Precious Matsoso, Carl Michael Nathanson, Piero Olliaro, Rosanna W. Peeling and Andy Ramsay are all at the UNICEF/UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland.,

    Jane Cunningham, Precious Matsoso, Carl Michael Nathanson, Piero Olliaro, Rosanna W. Peeling & Andy Ramsay

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  1. Shabir Banoo
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Corresponding author

Correspondence to Rosanna W. Peeling.

Supplementary information

Appendix 1

Standards for reporting of diagnostic accuracy (STARD) list (PDF 100 kb)

Appendix 2

Sample informed consent form (PDF 99 kb)

Glossary

Accuracy

The percentage of correct results obtained by the test under evaluation compared with the results of a reference or 'gold standard' test. Usually expressed as the number of correct results divided by the total number of results, multiplied by 100.

Blinding

Interpreting a test result without knowledge of a patient's condition or previous test results.

Confidence interval

The confidence interval quantifies the uncertainty in measurement; usually reported as the 95% confidence interval, the range that we can be 95% certain covers the true value.

Negative predictive value (NPV)

The probability that a negative result accurately indicates the absence of infection.

Positive predictive value (PPV)

The probability that a positive result accurately indicates the presence of infection.

Prevalence

The proportion of a given population with an infection at a given time.

Proficiency panel

A collection of six or more mock or true specimens with positive and negative results for a particular test, used to ascertain the proficiency of the technologist in performing the test.

Quality assurance (QA)

An ongoing process of monitoring a system for reproducibility or reliability of results, with which corrective action can be instituted if standards are not met.

Reference standard

The best available approximation of a true result, generally indicating a test method that is currently accepted as reasonably, but not necessarily, 100% accurate. It is used as the reference method for assessing the performance characteristics of another test method.

Reproducibility

A measure of the extent to which replicate analyses using identical procedures agree with each other.

Sensitivity

The probability (percentage) that patients with the infection (determined by the result of the reference or 'gold standard' test) will have a positive result using the test under evaluation.

Specificity

The probability (percentage) that patients without the infection (determined by the result of the reference or 'gold standard' test) will have a negative result using the test under evaluation.

Tests

Any method for obtaining additional information regarding a patient's health status.

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Banoo, S., Bell, D., Bossuyt, P. et al. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 5 (Suppl 11), S21–S31 (2007). https://doi.org/10.1038/nrmicro1523x

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