TY - JOUR 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 DO - 10.1136/sextrans-2017-053443 SP - sextrans-2017-053443 AU - Louise M Causer AU - Rebecca J Guy AU - Sepehr N Tabrizi AU - David M Whiley AU - David John Speers AU - James Ward AU - Annie Tangey AU - Steven G Badman AU - Belinda Hengel AU - Lisa Jane Natoli AU - David A Anderson AU - Handan Wand AU - David Wilson AU - David G Regan AU - Mark Shephard AU - Basil Donovan AU - Christopher K Fairley AU - John M Kaldor Y1 - 2018/05/10 UR - http://sti.bmj.com/content/early/2018/05/10/sextrans-2017-053443.abstract N2 - 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. ER -