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.
- Chlamydia trachomatis
- Neisseria gonorrhoea
- primary care
- molecular techniques
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Handling editor Nicola Low
Contributors The study was designed by all authors. LMC, LJN, BH, AT and SGB were responsible for data collection. SNT, DMW and DJS were responsible for reference and further laboratory testing results. LMC, RJG and HW were responsible for data analysis. All authors contributed to the interpretation of results and findings. LMC drafted the first full manuscript with input to the final version from all other authors. All authors contributed to the interpretation and writing of the manuscript.
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.
Disclaimer The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests None declared.
Ethics approval West Australian Aboriginal Health Ethics Research Committee (HREC 396); Kimberley Aboriginal Health Planning Forum (HREC 2012-003); West Australian Community Health Board Research Ethics Committee (HREC 2012/16); Townsville (HREC/12/QTHS/133)/Cairns and Hinterland Hospital and Health Service (HREC 12/QCH/89-810); Aboriginal Health Council South Australia (HREC 04-13-500).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement As per the approved study protocol, access to these data is limited to select named investigators and remains the property of the participating health services. Access to these data may be considered by contacting the corresponding author of this manuscript.