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https://hdl.handle.net/2440/120928
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Type: | Journal article |
Title: | Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation |
Author: | Causer, L.M. Guy, R.J. Tabrizi, S.N. Whiley, D.M. Speers, D.J. Ward, J. Tangey, A. Badman, S.G. Hengel, B. Natoli, L.J. Anderson, D.A. Wand, H. Wilson, D. Regan, D.G. Shephard, M. Donovan, B. Fairley, C.K. Kaldor, J.M. |
Citation: | Sexually Transmitted Infections, 2018; 94(5):340-345 |
Publisher: | BMJ Publishing |
Issue Date: | 2018 |
ISSN: | 1368-4973 1472-3263 |
Statement of Responsibility: | 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 |
Abstract: | 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. |
Keywords: | Molecular testing; primary health care |
Rights: | © 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. |
DOI: | 10.1136/sextrans-2017-053443 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1009902 http://purl.org/au-research/grants/nhmrc/1071269 |
Published version: | http://dx.doi.org/10.1136/sextrans-2017-053443 |
Appears in Collections: | Aurora harvest 8 Medicine publications |
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