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Evaluation of diagnostic tests for infectious diseases: general principles


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Figure 1: Essential elements in designing diagnostic test evaluations.


  1. Greenhalgh, T. How to read a paper: papers that report diagnostic or screening tests. Br. Med. J. 315, 540– 543 (1997).

    CAS  Article  Google Scholar 

  2. Borriello, S. P. Near-patient microbiological tests. Br. Med. J. 319, 298– 301 (1999).

    CAS  Article  Google Scholar 

  3. Bossuyt, P. M. et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD Initiative. Clin. Chem. 49, 1– 6 (2003).

    CAS  Article  Google Scholar 

  4. Bossuyt, P. M. et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin. Chem. 49, 7– 18 (2003).

    CAS  Article  Google Scholar 

  5. Smith, P. G. & Morrow, R. H., eds Field Trials of Health Interventions in Developing Countries: A Toolbox, (Macmillan, London, 1996).

    Google Scholar 

  6. Alonzo, T. D & Pepe, M. S. Using a combination of reference tests to assess the accuracy of a new diagnostic test. Statist. Med. 18, 2987– 3003 (1999).

    CAS  Article  Google Scholar 

  7. Pepe, M. S. Statistical Evaluation of Medical Tests for Classification and Prediction. (Oxford Univ. Press, 2003).

    Google Scholar 

  8. Gardner, M. J. & Altman, D. G. Estimating with confidence. Br. Med. J. 296, 1210– 1211 (1988).

    CAS  Article  Google Scholar 

  9. McGinn, T. et al. Tips for learners of evidence-based medicine: 3. Measures of observer variability (kappa statistic). Can. Med. Assoc. J. 171, 1369– 1373 (2004).

    Article  Google Scholar 

  10. WHO. Standard Operating Procedures for Clinical Investigators. UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR). TDR/ TDP/SOP99.1 <[online]> (1999)

  11. WHO/Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002).

  12. Nuffield Council on Bioethics. The Ethics of Research Related to Healthcare in Developing Countries <[online]> (2002)

  13. WHO. Guidelines for Good Laboratory Practice. UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases TDR/ PRD/GLP/01.2 (WHO/TDR, Geneva, 2001).

  14. Delaney, B. C. et al. Systematic review of near-patient test evaluations in primary care. Br. Med. J. 319, 824– 827 (1999).

    CAS  Article  Google Scholar 

  15. Reid, M. C., Lachs, M. S. & Feinstein, A. Use of methodological standards in diagnostic test research. Getting better but still not good. J. Amer. Med. Assoc. 274, 645– 651 (1995).

    CAS  Article  Google Scholar 

  16. Small, P. M. & Perkins, M. D. More rigour needed in trials of new diagnostic agents for tuberculosis. Lancet 356, 1048– 1049 (2000).

    CAS  Article  Google Scholar 

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

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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.


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.


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.


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


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.


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.


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 4, S21–S31 (2006).

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