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Clinic-based evaluation of the dual Xpert CT/NG assay on the GeneXpert System for screening for extragenital chlamydial and gonococcal infections amongst men who have sex with men

Cordioli, Maddalena (författare)
Infectious Diseases Section, Department of Medicine, Verona University Hospital, Verona, Italyt; WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Verona University Hospital, Verona, Italy
Gios, Lorenzo (författare)
Infectious Diseases Section, Department of Medicine, Verona University Hospital, Verona, Italy; WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Verona University Hospital, Verona, Italy
Erbogasto, Anna (författare)
Infectious Diseases Section, Department of Medicine, Verona University Hospital, Verona, Italy
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Mirandola, Massimo (författare)
Infectious Diseases Section, Department of Medicine, Verona University Hospital, Verona, Italy; WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Verona University Hospital, Verona, Italy; School of Sport and Health Sciences, University of Brighton, Brighton, UK
Sandri, Angela (författare)
Microbiology Section, Department of Diagnostics and Public Health, University of Verona, Verona, Italy
Padovese, Valeska (författare)
Genitourinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta
Caceres, Carlos (författare)
Centro de Investigación Interdisciplinaria en Sexualidad, Sida y Sociedad, Universidad Peruana Cayetano Heredia, Lima, Peru
Vargas, Silver (författare)
Centro de Investigación Interdisciplinaria en Sexualidad, Sida y Sociedad, Universidad Peruana Cayetano Heredia, Lima, Peru
Blondeel, Karel (författare)
Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
Silva, Ronaldo (författare)
Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland
Kiarie, James (författare)
Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland
Kurbonov, Firdavs (författare)
Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland
Peeling, Rosanna W. (författare)
Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK
Thwin, Soe Soe (författare)
Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland
Golparian, Daniel, 1984- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,WHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
Unemo, Magnus, 1970- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Institute for Global Health, University College London (UCL), London, UK
Toskin, Igor (författare)
Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland
ProSPeRo Network, - (bidragsgivare)
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 (creator_code:org_t)
BioMed Central (BMC), 2024
2024
Engelska.
Ingår i: BMC Infectious Diseases. - : BioMed Central (BMC). - 1471-2334. ; 24:Suppl 1
Relaterad länk:
https://doi.org/10.1...
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https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections have increased globally. Asymptomatic infections represent a significant risk of long-term complications. Men who have sex with men (MSM) are disproportionally affected, underscoring the need to offer screening programmes to this population. CT/NG Point of Care Testing (POCT) constitutes a strategic tool to improve the continuum of STI care, however extensive real-life evaluations amongst at risk populations are lacking. The aim of this study is to estimate the GeneXpert CT/NG assay performance and usability for CT and NG at genital and extragenital sites for screening amongst MSM.METHODS: This study was a multi-site sexual health clinic-based evaluation (Italy, Malta and Peru) with consecutive enrolment. A first void urine sample (divided in two aliquots), two oropharyngeal and two anorectal swabs were collected for each study participant. One specimen set (one for each anatomical site) was tested with the dual index test (Cepheid) at the clinics by the healthcare staff, the other set with FDA/CE approved Nucleic Acid Amplification Tests (NAATs) at the laboratory. Clinical sites and reference laboratories participated in an internal and external quality control programme. Sensitivity, specificity, positive and negative likelihood ratios, positive and negative predictive values for each anatomical site were estimated using a meta-analytic approach.RESULTS: One thousand seven hundred two MSM were recruited across all clinical sites for a total of 5049 biological specimens. NG and CT were respectively detected in 274 and 287 of samples. Overall, the NG POCT sensitivity and specificity was 91.43% and 99.75% in urine (LR + 372.80, LR- 0.09), 89.68% and 99.55% in rectal specimens (LR + 197.30, LR- 0.10) and 75.87% and 98.77% at the pharynx respectively (LR + 61.94, LR- 0.24). The CT component of the POCT sensitivity was 84.82% and specificity 99.63% in urine (LR + 228.68, LR- 0.15), 78.07% and 99.19% respectively on rectal site (LR + 96.23, LR-0.22), 67.79% and 99.88% respectively at pharyngeal site (LR + 554.89, LR- 0.32). 95.95% of MSM reported to be willing to wait for POCT results and no provider reported difficulties in terms of performance or interpretation of the results of the Xpert CT/NG.CONCLUSION: Rapid turnaround time, ease of use and high acceptability make the Xpert CT/NG testing system a strategic tool for increasing testing frequency, reaching those not yet tested and offering the possibility of immediate treatment if needed. The assay showed good negative likelihood ratios and confirms its use to rule out CT/NG infections. Sensitivity varied across sites and pathogens. Periodic staff training at the testing sites should be mandatory.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

Nyckelord

Chlamydia trachomatis
Neisseria gonorrhoeae
Gonococcal and chlamydial infections
Men who have Sex with Men
Point-of-Care Tests (POCTs)
Public Health
Sexually transmitted infections
diagnostic evaluation

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