Analytical Evaluation of GeneXpert CT/NG, the First Genetic Point-of-Care Assay for Simultaneous Detection of Neisseria gonorrhoeae and Chlamydia trachomatis

Tabrizi, Sepehr N.; Unemo, Magnus; Golparian, Daniel; Twin, Jimmy; Limnios, Athena; Lahra, Monica M; Guy, Rebecca

doi:10.1128/jcm.00806-13

Cited by 74 publications

(61 citation statements)

References 27 publications

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“…In 2013, the GeneXpert CT/NG assay (Cepheid, Sunnyvale, CA) became the first nucleic acid-based test for CT/NG available for POC use. It has been shown to have high analytical9 and clinical10 accuracy compared with established commercial nucleic acid amplification tests (NAAT) in highly controlled laboratory environments with dedicated staff. However, the ultimate demonstration of a POC test’s performance is not in this ideal setting, but rather in the hands of clinicians in front-line settings where patient care takes place 11…”

Section: Introductionmentioning

confidence: 99%

Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation

et al. 2018

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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.

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Section: Introductionmentioning

confidence: 99%

Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation

et al. 2018

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“…We previously evaluated the GeneXpert platform for point-ofcare testing and treatment of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in routine-clinic settings in Australia (10) and are currently evaluating this approach among antenatal women in Papua New Guinea (A. Vallely, presented at the World STI & HIV Congress 2015, Brisbane, Australia, 13 to 16 September 2015). In this paper, we report findings from the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test conducted at the point of care in the high-burden, low-income setting of Papua New Guinea (12)(13)(14).…”

mentioning

confidence: 99%

Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens

Toliman

Badman²,

Gabuzzi

et al. 2016

J Clin Microbiol

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iThe World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. T he recognition that infection with certain high-risk types of human papillomavirus (HPV) (hrHPV) is the primary cause of both cervical precancer and cancer led to the development of new technologies that would allow hrHPV DNA to be detected as part of population-based screening. These tests are more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN) and invasive disease and have comparable specificities (1, 2), and their potential efficacy for populationbased cervical screening has been conclusively demonstrated in large-scale randomized trials and prospective studies (3-5). These findings led to recommendations in Europe, the United States, Australia, and other high-income settings for cervical screening programs to incorporate hrHPV DNA testing (2, 5-7). In this rapidly developing environment, and based on trials directly comparing HPV screening with cytology (3-5), the World Health Organization recently recommended that hrHPV testing be incorporated into cervical screening programs in low-and middle-income countries (LIMCs), particularly where cytological testing is not available and where visual inspection of the cervix after the application of acetic acid (VIA) or visual inspection after the application of Lugol's iodine (VILI) is the principal cervical screening strategy (8).The Xpert HPV test (GeneXpert; Cepheid, Sunnyvale, CA) is a newly available, rapid, fully automated, and easy-to-use nonbatch test for hrHPV infection that is as accurate as laboratory-based nucleic acid amplification tests (NAATs) (2, 9). Xpert HPV compared favorably to the FDA-approved Cobas 4800 (Roche Molecular Systems, Pleasanton, CA) and Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) assays for the detection of hrHPV using clinician-collected cervical specimens (2, 9) and had sensitivity, specificity, and positive predictive values comparable to those of the above-mentioned assays for high-grade CIN (2). Disposable cartridges hold the reagents, primers, and probes for the simultaneous detection of 14 hrHPV types responsible for over 95% of cervical cancers ; a human reference gene; and an internal probe check control (PCC) (2). The system monitors the presence of inh...

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“…Of those testing positive to gonorrhoea, 85% will receive treatment within 21 days [15] but some will remain infected post-treatment due to treatment failure as a result of AMR or other factors such as non-adherence. We assume that 44% of the population will be tested for STI annually through general health check-ups and screening [15], using a diagnostic test of 100% sensitivity [16].…”

Section: Methodsmentioning

confidence: 99%

“…Prevalence of 7-8% has been reported for 16-34 years old and even higher for [16][17][18][19] year olds at more than 10% [3]. Currently, most gonorrhoea infections diagnosed in remote Indigenous communities are sensitive to and treated with penicillin, whereas the predominant gonorrhoea strains circulating in urban Australia and neighbouring countries are resistant to penicillin [4].…”

Section: Introductionmentioning

confidence: 99%

001.6 Exploring the benefits of molecular testing for gonorrhoea antibiotic resistance surveillance in remote settings

Hui¹,

Ryder²,

Su³

et al. 2015

Sex Transm Infect

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Analytical Evaluation of GeneXpert CT/NG, the First Genetic Point-of-Care Assay for Simultaneous Detection of Neisseria gonorrhoeae and Chlamydia trachomatis

Cited by 74 publications

References 27 publications

Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation

Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation

Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens

001.6 Exploring the benefits of molecular testing for gonorrhoea antibiotic resistance surveillance in remote settings

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