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Confirmatory assays are essential when using molecular testing for Neisseria gonorrhoeae in low-prevalence settings: insights from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3)
  1. Nigel Field1,
  2. Soazig Clifton1,2,
  3. Sarah Alexander3,
  4. Catherine A Ison3,
  5. Gwenda Hughes4,
  6. Simon Beddows5,
  7. Clare Tanton1,
  8. Kate Soldan4,
  9. Filomeno Coelho da Silva5,
  10. Catherine H Mercer1,
  11. Kaye Wellings6,
  12. Anne M Johnson1,
  13. Pam Sonnenberg1
  1. 1Research Department of Infection & Population Health, University College London, Mortimer Market Centre, London, UK
  2. 2NatCen Social Research, London, UK
  3. 3Sexually Transmitted Bacteria Reference Unit, Public Health England, London, UK
  4. 4Public Health England, National Centre for Infectious Disease Surveillance and Control, London, UK
  5. 5Virus Reference Department, Public Health England, London, UK
  6. 6Department of Social and Environmental Research, London School of Hygiene & Tropical Medicine, London, UK
  1. Correspondence to Dr Nigel Field, Research Department of Infection and Population Health, University College London, London WC1E 6JB, UK; nigel.field{at}ucl.ac.uk

Abstract

Objectives To investigate the occurrence of unconfirmed positive gonorrhoea results when using molecular testing within a large population-based survey.

Design, setting and participants Between 2010 and 2012, we did a probability sample survey of 15 162 men and women aged 16–74 years in Britain. Urine from participants aged 16–44 years reporting ≥1 lifetime sexual partner was tested for Neisseria gonorrhoeae and Chlamydia trachomatis using the Aptima Combo 2 (AC2) assay, with positive or equivocal results confirmed with molecular assays using different nucleic acid targets.

Results A total of 4550 participants aged 16–44 years had urine test results (1885 men; 2665 women). For gonorrhoea, 18 samples initially tested positive and eight were equivocal. Only five out of 26 confirmed, giving a positive predictive value (PPV) for the initial testing of 19% (95% CI 4% to 34%). Most (86% (18/21)) participants with unconfirmed positive results for gonorrhoea reported zero or one sexual partner without condoms in the past year and none had chlamydia co-infection, whereas all five with confirmed gonorrhoea reported at least two recent sexual partners without condoms, and four had chlamydia co-infection. The weighted prevalence for gonorrhoea positivity fell from 0.4% (0.3% to 0.7%) after initial screening to <0.1% (0.0% to 0.1%) after confirmatory testing. By comparison, 103 samples tested positive or equivocal for chlamydia and 98 were confirmed (PPV=95% (91% to 99%)).

Conclusions We highlight the low PPV for gonorrhoea of an unconfirmed reactive test when deploying molecular testing in a low-prevalence population. Failure to undertake confirmatory testing in low-prevalence settings may lead to inappropriate diagnoses, unnecessary treatment and overestimation of population prevalence.

  • NEISSERIA GONORRHOEA
  • TESTING
  • EPIDEMIOLOGY (CLINICAL)
  • PUBLIC HEALTH

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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