Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: A diagnostic test evaluation

Louise M. Causer*, Rebecca J. Guy, Sepehr N. Tabrizi, David M. Whiley, David John Speers, James Ward, Annie Tangey, Steven G. Badman, Belinda Hengel, Lisa Jane Natoli, David A. Anderson, Handan Wand, David Wilson, David G. Regan, Mark Shephard, Basil Donovan, Christopher K. Fairley, John M. Kaldor

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

31 Citations (Scopus)


Objectives A new molecular test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (GeneXpert CT/NG) has been demonstrated to be as accurate as conventional nucleic acid amplification tests (NAAT), but performance has not been evaluated in routine primary care, performed at the point of care by clinicians. We aimed to examine its diagnostic performance when used by clinicians in remote community health services in Australia with high prevalences of CT and NG infection. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#12613000808741) Methods At 12 health services, training was provided to 99 clinicians in the use of the GeneXpert CT/NG assay who tested specimens from all patients undergoing STI screening. Specimens were also sent in parallel for conventional laboratory-based NAATs and the concordance of results was evaluated. Results Clinicians conducted 2486 tests: CT concordance was 99.4% (95% CI 99.1 to 99.7) with a positive concordance of 98.6% (95% CI 95.9 to 99.7) and negative concordance of 99.5% (95% CI 99.1 to 99.8); NG concordance was 99.9% (95% CI 99.7 to 100.0) with a positive concordance of 100.0% (95% CI 97.5 to 100.0) and negative concordance of 99.9% (95% CI 99.7 to 100.0). Conclusions In this first study reporting routine point-of-care use of GeneXpert CT/NG by primary care clinicians, we found excellent concordance with conventional NAATs. The use of the GeneXpert CT/NG at the point of care could potentially transform management and control of these infections in many endemic settings, including low/middle-income countries.

Original languageEnglish
Pages (from-to)340-345
Number of pages6
JournalSexually Transmitted Infections
Issue number5
Publication statusPublished - Aug 2018
Externally publishedYes

Bibliographical note

Funding Information:
Funding this work was supported by the australian national Health and Medical council awards (nHMrc Project grant application no 1009902 and Program grant application no 1071269). cepheid (Sunnyvale, ca) supplied the genXpert devices and cartridges at reduced price.

Publisher Copyright:
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.


  • Chlamydia trachomatis
  • diagnosis
  • molecular techniques
  • Neisseria gonorrhoea
  • primary care


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