Evaluation of diagnostic tests for infectious diseases: general principles (original) (raw)

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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

Authors and Affiliations

  1. Medicines Control Council of South Africa, Pretoria, South Africa
    Shabir Banoo
  2. Malaria and other Vector-borne and Parasitic Diseases, World Health Organization–Regional Office for the Western Pacific, Manila, Philippines
    David Bell
  3. Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
    Patrick Bossuyt
  4. Veterinary School, University of Bristol, Bristol, UK
    Alan Herring
  5. Clinical Research Unit, London School of Hygiene and Tropical Medicine, London, UK
    David Mabey
  6. Division of Microbiology Devices, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, USA
    Freddie Poole
  7. Infectious Diseases Epidemiology Unit, London School of Hygiene and Tropical Medicine, London, UK
    Peter G Smith
  8. Tulip Group of Companies, Goa, India
    N. Sriram
  9. US Naval Medical Research Unit 2, Jakarta, Indonesia
    Chansuda Wongsrichanalai
  10. Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland
    Ralf Linke, Rick O'Brien & Mark Perkins
  11. 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

Authors

  1. Shabir Banoo
  2. David Bell
  3. Patrick Bossuyt
  4. Alan Herring
  5. David Mabey
  6. Freddie Poole
  7. Peter G Smith
  8. N. Sriram
  9. Chansuda Wongsrichanalai
  10. Ralf Linke
  11. Rick O'Brien
  12. Mark Perkins
  13. Jane Cunningham
  14. Precious Matsoso
  15. Carl Michael Nathanson
  16. Piero Olliaro
  17. Rosanna W. Peeling
  18. Andy Ramsay

Corresponding author

Correspondence toRosanna W. Peeling.

Supplementary information

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 4 (Suppl 12), S20–S32 (2006). https://doi.org/10.1038/nrmicro1570

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