RT Journal Article
SR Electronic
T1 Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation
JF Sexually Transmitted Infections
JO Sex Transm Infect
FD BMJ Publishing Group Ltd
SP sextrans-2017-053443
DO 10.1136/sextrans-2017-053443
A1 Louise M Causer
A1 Rebecca J Guy
A1 Sepehr N Tabrizi
A1 David M Whiley
A1 David John Speers
A1 James Ward
A1 Annie Tangey
A1 Steven G Badman
A1 Belinda Hengel
A1 Lisa Jane Natoli
A1 David A Anderson
A1 Handan Wand
A1 David Wilson
A1 David G Regan
A1 Mark Shephard
A1 Basil Donovan
A1 Christopher K Fairley
A1 John M Kaldor
YR 2018
UL http://sti.bmj.com/content/early/2018/05/10/sextrans-2017-053443.abstract
AB 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.