Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation
| Autor: | David M. Whiley, Steven G Badman, John M. Kaldor, David A. Anderson, Lisa Natoli, Mark Shephard, David J. Speers, Belinda Hengel, Sepehr N. Tabrizi, David G. Regan, Louise M. Causer, Basil Donovan, Rebecca Guy, Handan Wand, Christopher K Fairley, Annie Tangey, James Ward, David Wilson |
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| Rok vydání: | 2018 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Native Hawaiian or Other Pacific Islander Concordance 030106 microbiology Chlamydia trachomatis Dermatology Primary care medicine.disease_cause Physicians Primary Care Specimen Handling Gonorrhea 03 medical and health sciences 0302 clinical medicine Internal medicine Humans Medicine 030212 general & internal medicine Point of care Cross-Over Studies GeneXpert MTB/RIF Chlamydia Primary Health Care business.industry Australia Community Health Centers Chlamydia Infections medicine.disease Neisseria gonorrhoeae Test (assessment) Clinical trial Infectious Diseases Molecular Diagnostic Techniques Point-of-Care Testing Female business Nucleic Acid Amplification Techniques New Zealand |
| Zdroj: | Sexually Transmitted Infections. 94:340-345 |
| ISSN: | 1472-3263 1368-4973 |
| Popis: | ObjectivesA 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)MethodsAt 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.ResultsClinicians 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).ConclusionsIn 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. |
| Databáze: | OpenAIRE |
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