Free Standard AU & NZ Shipping For All Book Orders Over $80!
Register      Login
Microbiology Australia Microbiology Australia Society
Microbiology Australia, bringing Microbiologists together
RESEARCH ARTICLE (Open Access)

The past, present and future of molecular testing for Neisseria gonorrhoeae in Australia: still challenging

Todd M. Pryce https://orcid.org/0000-0002-5293-9795 A *
+ Author Affiliations
- Author Affiliations

A Department of Clinical Microbiology, PathWest Laboratory Medicine WA, Fiona Stanley Hospital, Murdoch, WA 6150, Australia.




Todd Pryce is the senior medical scientist in charge of molecular diagnostics, serology and typing at the Department of Clinical Microbiology, PathWest Laboratory Medicine WA. Todd has 31-year history of working in a clinical microbiology laboratory in bacteriology, molecular diagnostics and research. Interests include qualitative and quantitative molecular methods in virology, bacteriology and mycology, Neisseria gonorrhoeae and sexually transmitted infection testing, novel multi-marker approaches for clinical laboratory testing and detection of antimicrobial resistant markers. Todd is a PhD candidate at Flinders University.

* Correspondence to: todd.pryce@health.wa.gov.au

Microbiology Australia https://doi.org/10.1071/MA24037
Submitted: 31 May 2024  Accepted: 29 July 2024  Published: 14 August 2024

© 2024 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of the ASM. This is an open access article distributed under the Creative Commons Attribution 4.0 International License (CC BY).

Abstract

Nucleic-acid amplification tests (NAATs) for Neisseria gonorrhoeae, particularly earlier generation tests, have been beset with specificity problems associated with cross reaction with commensal neisseriae. This is a particular problem for extragenital samples such as pharyngeal swabs, which are loaded with commensal Neisseria species and also a common site of infection for N. gonorrhoeae. To address the specificity issues, supplementary testing (whereby samples testing positive in a screening NAAT are reflexively tested with a secondary NAAT) has been widely implemented, with associated guidelines in place in Australia since 2005. Unlike earlier generation tests, modern commercial N. gonorrhoeae NAATs are (for the most part) much improved in terms of sensitivity and specificity and some now include testing claims for oropharyngeal and anorectal sites. This has raised questions over the ongoing utility of N. gonorrhoeae supplemental testing (particularly for urogenital sites) and left supplemental testing needing to play ‘catch-up’ in terms of sensitivity compared to newer commercial NAATs. More recently, supplemental testing has found added clinical utility with the addition of antimicrobial resistance (AMR) markers. Here I present the current N. gonorrhoeae testing guidelines, recent improvements in N. gonorrhoeae NAATs, discuss the changing role of supplemental testing and future sexually transmitted infection (STI) testing needs.

Keywords: AMR, antimicrobial resistance markers, antimicrobial resistance, clinical specificity, extragenital sites, high-throughput assays, Neisseria gonorrhoeae, point-of-care testing, sexually transmitted infection, STI, supplementary testing.

Biographies

MA24037_B1.gif

Todd Pryce is the senior medical scientist in charge of molecular diagnostics, serology and typing at the Department of Clinical Microbiology, PathWest Laboratory Medicine WA. Todd has 31-year history of working in a clinical microbiology laboratory in bacteriology, molecular diagnostics and research. Interests include qualitative and quantitative molecular methods in virology, bacteriology and mycology, Neisseria gonorrhoeae and sexually transmitted infection testing, novel multi-marker approaches for clinical laboratory testing and detection of antimicrobial resistant markers. Todd is a PhD candidate at Flinders University.

References

Rowley J et al. (2019) Chlamydia, gonorrhoea, trichomoniasis and syphilis: global prevalence and incidence estimates, 2016. Bull World Health Organ 97, 548-562.
| Crossref | Google Scholar | PubMed |

Australian Government, Department of Health and Aged Care (2024) National Notifiable Diseases Surveillance System (NNDSS) data visualisation tool. Commonwealth of Australia. https://www.health.gov.au/resources/apps-and-tools/national-notifiable-diseases-surveillance-system-nndss-data-visualisation-tool

Belkacem A et al. (2013) Changing patterns of disseminated gonococcal infection in France: cross-sectional data 2009-2011. Sex Transm Infect 89, 613-615.
| Crossref | Google Scholar | PubMed |

Vallely LM et al. (2021) Adverse pregnancy and neonatal outcomes associated with Neisseria gonorrhoeae: systematic review and meta-analysis. Sex Transm Infect 97, 104-111.
| Crossref | Google Scholar | PubMed |

Australian Government, Department of Health and Aged Care (2019) Fifth National Aboriginal and Torres Strait Islander Bloodborne Viruses and Sexually Transmissible Infections Strategy 2018–2022. Commonwealth of Australia. https://www.health.gov.au/resources/publications/fifth-national-aboriginal-and-torres-strait-islander-bloodborne-viruses-and-sexually-transmissible-infections-strategy-2018-2022

Pryce TM et al. (2024) Maximizing the Neisseria gonorrhoeae confirmatory rate and the genotypic detection of ciprofloxacin resistance for samples screened with cobas CT/NG. J Clin Microbiol 62, e01039-01023.
| Crossref | Google Scholar | PubMed |

Whiley DM, Lahra MM (2015) Review of 2005 Public Health Laboratory Network Neisseria gonorrhoeae nucleic acid amplification tests guidelines. Commun Dis Intell Q Rep 39, 42-5.
| Google Scholar | PubMed |

Perry MD et al. (2014) Is confirmatory testing of Roche cobas 4800 CT/NG test Neisseria gonorrhoeae positive samples required? Comparison of the Roche cobas 4800 CT/NG test with an opa/pap duplex assay for the detection of N. gonorrhoeae. Sex Transm Infect 90, 303-308.
| Crossref | Google Scholar | PubMed |

Upton A et al. (2013) Neisseria gonorrhoeae false-positive result obtained from a pharyngeal swab by using the Roche cobas 4800 CT/NG assay in New Zealand in 2012. J Clin Microbiol 51, 1609-1610.
| Crossref | Google Scholar | PubMed |

10  Pryce TM et al. (2023) A previously documented Neisseria macacae isolate providing a false-positive result with Roche cobas 4800 CT/NG does not cross-react with the later generation cobas 6800 CT/NG assay. Eur J Clin Microbiol Infect Dis 42, 121-123.
| Crossref | Google Scholar | PubMed |

11  Smith DW et al. (2005) Guidelines for the use and interpretation of nucleic acid detection tests for Neisseria gonorrhoeae in Australia: a position paper on behalf of the Public Health Laboratory Network. Commun Dis Intell Q Rep 29, 358-365.
| Google Scholar | PubMed |

12  Bromhead C et al. (2013) Comparison of the cobas 4800 CT/NG test with culture for detecting Neisseria gonorrhoeae in genital and nongenital specimens in a low-prevalence population in New Zealand. J Clin Microbiol 51, 1505-1509.
| Crossref | Google Scholar | PubMed |

13  Fifer H et al. (2020) 2018 UK national guideline for the management of infection with Neisseria gonorrhoeae. Int J STD AIDS 31, 4-15.
| Crossref | Google Scholar | PubMed |

14  Pryce TM et al. (2021) Second- and third-generation commercial Neisseria gonorrhoeae screening assays and the ongoing issues of false-positive results and confirmatory testing. Eur J Clin Microbiol Infect Dis 40, 67-75.
| Crossref | Google Scholar | PubMed |

15  Adamson PC et al. (2020) Analytical evaluation of the Abbott RealTime CT/NG assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal swabs. J Mol Diagn 22, 811-816.
| Crossref | Google Scholar | PubMed |

16  Mohammed H et al. (2015) Frequency and correlates of culture-positive infection with Neisseria gonorrhoeae in England: a review of sentinel surveillance data. Sex Transm Infect 91, 287-293.
| Crossref | Google Scholar | PubMed |

17  Hook EW, Van Der Pol B (2013) Evolving gonococcal antimicrobial resistance: research priorities and implications for management. Sex Transm Infect 89, iv60-2.
| Crossref | Google Scholar | PubMed |

18  Unemo M et al. (2021) WHO global antimicrobial resistance surveillance for Neisseria gonorrhoeae 2017–18: a retrospective observational study. Lancet Microbe 2, e627-e636.
| Crossref | Google Scholar | PubMed |

19  Tabrizi SN et al. (2011) Evaluation of six commercial nucleic acid amplification tests for detection of Neisseria gonorrhoeae and other Neisseria species. J Clin Microbiol 49, 3610-3615.
| Crossref | Google Scholar | PubMed |

20  Whiley DM et al. (2006) Nucleic acid amplification testing for Neisseria gonorrhoeae: an ongoing challenge. J Mol Diagn 8, 3-15.
| Crossref | Google Scholar | PubMed |

21  Moncada J et al. (2008) Evaluation of CDC-recommended approaches for confirmatory testing of positive Neisseria gonorrhoeae nucleic acid amplification test results. J Clin Microbiol 46, 1614-1619.
| Crossref | Google Scholar | PubMed |

22  Whiley DM et al. (2011) False-negative results using Neisseria gonorrhoeae porA pseudogene PCR – a clinical gonococcal isolate with an N. meningitidis porA sequence, Australia, March 2011. Euro Surveill 16, 19874.
| Google Scholar | PubMed |

23  Whiley DM et al. (2007) Neisseria gonorrhoeae NAAT – a problem down under. Microbiol Aust 28, 9-11.
| Crossref | Google Scholar |

24  Pryce TM et al. (2012) Confirmatory rates of Neisseria gonorrhoeae from urogenital and non-urogenital sites: need to review current guidelines for N. gonorrhoeae confirmation. In ‘ASM 2012 Annual Scientific Meeting and Exhibition program’, 1–4 July 2012, Brisbane, Qld, Australia. Abstract 524, p. 105. (The ASM)

25  van Niekerk JM et al. (2021) Despite excellent test characteristics of the cobas 4800 CT/NG assay, detection of oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae remains challenging. J Clin Microbiol 59, e02137-20.
| Crossref | Google Scholar | PubMed |

26  Lahra MM et al. (2022) Australian Gonococcal Surveillance Programme Annual Report, 2021. Commun Dis Intell 46,.
| Crossref | Google Scholar | PubMed |

27  Buckley C et al. (2015) Multitarget PCR assay for direct detection of penicillinase-producing Neisseria gonorrhoeae for enhanced surveillance of gonococcal antimicrobial resistance. J Clin Microbiol 53, 2706-2708.
| Crossref | Google Scholar | PubMed |

28  Goire N et al. (2011) Enhancing gonococcal antimicrobial resistance surveillance: a real-time PCR assay for detection of penicillinase-producing Neisseria gonorrhoeae by use of noncultured clinical samples. J Clin Microbiol 49, 513-518.
| Crossref | Google Scholar | PubMed |

29  Golparian D, Unemo M (2022) Antimicrobial resistance prediction in Neisseria gonorrhoeae: current status and future prospects. Expert Rev Mol Diagn 22, 29-48.
| Crossref | Google Scholar | PubMed |

30  Goldstein E et al. (2024) Impact of molecular ciprofloxacin resistance testing in management of gonorrhoea in a large urban clinic. Sex Transm Infect 100, 226-230.
| Crossref | Google Scholar | PubMed |