Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Guidelines
  • Published:

Evaluation of rapid diagnostic tests: chlamydia and gonorrhoea

Abstract

WHO/TDR Sexually Transmitted Diseases Diagnostics Initiative

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Similar content being viewed by others

References

  1. WHO. Global Prevalence and Incidence of Selected Curable Sexually Transmitted Infections: Overview and Estimates. [online], (WHO, Geneva, 2001).

  2. Gift, T. L., Pate, M. S., Hook, E. W. 3rd & Kassler, W. J. The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for Chlamydia trachomatis. Sex. Transm. Dis. 26, 232– 240 (1999).

    Article  CAS  Google Scholar 

  3. Mukenge, L. et al. Syndromic versus laboratory-based diagnosis of cervical infections among female sex workers in Benin: implications of non-attendance for return visits. Sex. Transm. Dis. 29, 324– 330 (2002).

    Article  Google Scholar 

  4. WHO. Guidelines for the Management of Sexually Transmitted Infections. [online], (WHO, Geneva, 2003).

  5. Hawkes, S. et al. Reproductive-tract infections in women in low-income, low-prevalence situations: assessment of syndromic management in Matlab, Bangladesh. Lancet 354, 1776– 1781 (1999).

    Article  CAS  Google Scholar 

  6. Alary, M. et al. Evaluation of clinical algorithms for the diagnosis of gonococcal and chlamydial infections among men with urethral discharge or dysuria and women with vaginal discharge in Benin. Sex Transm. Infect. 74 (Suppl. 1), S44– S49 (1998).

    PubMed  Google Scholar 

  7. Sherrard, J. & Barlow, D. Gonorrhoea in men: clinical and diagnostic aspects. Genitourinar. Med. 72, 422– 426 (1996).

    CAS  Google Scholar 

  8. Manavi, K., Young, H., Clutterbuck, D. Sensitivity of microscopy for the rapid diagnosis of gonorrhoea in men and women and the role of gonorrhoeae serovars. Int. J. STD AIDS 14, 390– 394 (2003).

    Article  Google Scholar 

  9. Koumans, E. H., Johnson, R. E., Knapp, J. S. & St Louis, M. E. Laboratory testing for Neisseria gonorrhoeae in men and women introduced non-culture tests: a performance review with clinical and public health considerations. Clin. Infect. Dis. 27, 1171– 1180 (1998).

    Article  CAS  Google Scholar 

  10. Vickerman, P., Peeling, R. W., Watts, C. & Mabey, D. Detection of gonococcal infection: pros and cons of a rapid test. Mol. Diagn. 9, 175– 179 (2005).

    PubMed  Google Scholar 

  11. Young, H. et al. Preliminary evaluation of “Clearview Chlamydia” for the rapid detection of chlamydial antigen in cervical secretions. Genitourin. Med. 67, 120– 123 (1991).

    CAS  PubMed  PubMed Central  Google Scholar 

  12. Skulnick, M. et al. Comparison of the Clearview chlamydia test, Chlamydiazyme, and cell culture for detection of Chlamydia trachomatis in women with a low prevalence of infection. J. Clin. Microbiol. 29, 2086– 2088 (1991).

    CAS  PubMed  PubMed Central  Google Scholar 

  13. Stratton, N. J., Hirsch, L., Harris, F., de la Maza, L. M. & Peterson, E. M. Evaluation of the rapid CLEARVIEW Chlamydia test for direct detection of chlamydiae from cervical specimens. J. Clin. Microbiol. 29, 1551– 1553 (1991).

    CAS  PubMed  PubMed Central  Google Scholar 

  14. Arumainayagam, J. T., Matthews, R. S., Uthayakumar, S. & Clay, J. C. Evaluation of a novel solid-phase immunoassay, Clearview Chlamydia, for the rapid detection of Chlamydia trachomatis. J. Clin. Microbiol. 28, 2813– 2814 (1990).

    CAS  PubMed  PubMed Central  Google Scholar 

  15. Ferris, D. G. & Martin, W. H. A comparison of three rapid chlamydial tests in pregnant and nonpregnant women. J. Fam. Pract. 34, 593– 597 (1992).

    CAS  PubMed  Google Scholar 

  16. Vickerman, P., Watts, C. H., Alary, M., Mabey, D. & Peeling, R. Sensitivity requirements for the point of care diagnosis of Chlamydia trachomatis and Neiserria gonorrhoeae in women. Sex. Transm. Infect. 79, 363– 368 (2003).

    Article  CAS  Google Scholar 

  17. Hook, E. W., 3rd, Spitters, C., Reichart, C. A., Neumann, T. M. & Quinn, T. C. Use of cell culture and a rapid diagnostic assay for Chlamydia trachomatis screening. JAMA 272, 867– 870 (1994).

    Article  Google Scholar 

  18. Van Dyck, E., Smet, H., Van Damme, L. & Laga, M. Evaluation of the Roche Neisseria gonorrhoeae 16 S rRNA PCR for confirmation of AMPLICOR PCR-positive samples and comparison of its diagnostic performance according to storage conditions and preparation of endocervical specimens. J. Clin. Microbiol. 39, 2280– 2282 (2001).

    Article  CAS  Google Scholar 

  19. Van Dyck, E., Leven, M., Pattyn, S., Van Damme, L. & Laga, M. Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by enzyme immunoassay, culture and three nucleic acid amplified tests. J. Clin. Microbiol. 39, 1751– 1756 (2001).

    Article  CAS  Google Scholar 

  20. Boyadzhyan, B., Yashida, B., Yatabe, H., Patnaik, M. & Hill, C. S. Comparison of the APTIMA CT and GC assays with the APTIMA COMBO 2 assay, the Abbott LCx assay, and direct fluorescent-antibody and culture assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J. Clin. Microbiol. 42, 3089– 3093 (2004).

    Article  CAS  Google Scholar 

  21. Darwin, L. H. et al. Comparison of digene hybrid capture 2 and conventional culture for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in cervical specimens. J. Clin. Microbiol. 40, 641– 644 (2002).

    Article  Google Scholar 

  22. Martin, D., Cammarata, C. & Van Der Pol, B. Multicenter evaluation of AMPLICOR and automated COBAS AMPLICOR CT/NG tests for Neisseria gonorrhoeae. J. Clin. Microbiol. 38, 3544– 3549 (2000).

    CAS  PubMed  PubMed Central  Google Scholar 

  23. Panke, E. et al. Comparison of Gen-Probe DNA probe test and culture for the detection of Neisseria gonorrhoeae in endocervical specimens. J. Clin. Microbiol. 29, 883– 888 (1991).

    CAS  PubMed  PubMed Central  Google Scholar 

  24. Palmer, H. M., Mallinson, H., Wood, R. & Herring, A. J. Evaluation of the specificities of five DNA amplification methods for the detection of Neisseria gonorrhoeae. J. Clin. Microbiol. 41, 835– 837 (2003).

    Article  CAS  Google Scholar 

  25. Diermert, D. J., Libman, M. D. & Lebel, P. Confirmation by 16S r RNA PCR of the COBAS AMPLICOR CT/NG test for diagnosis of Neisseria gonorrhoeae infection in a low-prevalence population. J. Clin. Microbiol. 40, 4056– 4059 (2002).

    Article  Google Scholar 

  26. Benzaken, A. S. et al. The diagnosis of gonococcal infection in high risk women using a rapid test. Sex. Transm. Infect. (in the press).

  27. Stiles, T., Grant, V. & Mawby, N. Good Clinical Laboratory Practice (British Association of Research Quality Assurance, 2003).

    Google Scholar 

  28. Alary, M. et al. Evaluation of a rapid point-of-care test for the detection of gonococcal infection among female sex workers in Benin. Sex. Transm. Infect. (in the press).

  29. Black, C. M. Current methods of laboratory diagnosis of Chlamydia trachomatis infections. Clin. Microbiol. Rev. 10, 160– 184 (1997).

    Article  CAS  Google Scholar 

  30. Black, C. M. et al. Head-to-head multicenter comparison of DNA probe and nucleic acid amplification tests for Chlamydia trachomatis infection in women performed with an improved reference standard. J. Clin. Microbiol. 40, 3757– 3763 (2002).

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The WHO/TDR Sexually Transmitted Diseases Diagnostics Initiative (SDI) would like to Drs Yaw Adu-Darkodie, Michel Alary, Xiang-Sheng Chen, Carlos Conde, King Holmes, Edward Hook III, Robert Johnson, Laurie Markowitz, Adele Schwartz-Benzaken, Milton Tam, Chantapong Wasi and Yue-Ping Yin for their valuable input into the design and conduct of the SDI diagnostics evaluation scheme, which forms the basis of these guides.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Rosanna W. Peeling.

Supplementary information

Rights and permissions

Reprints and permissions

About this article

Cite this article

Herring, A., Ballard, R., Mabey, D. et al. Evaluation of rapid diagnostic tests: chlamydia and gonorrhoea. Nat Rev Microbiol 4 (Suppl 12), S41–S48 (2006). https://doi.org/10.1038/nrmicro1562

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrmicro1562

This article is cited by

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing