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Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women

Cordioli, Maddalena (författare)
WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy; Infectious Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy
Gios, Lorenzo (författare)
WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy; Infectious Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy
Mirandola, Massimo (författare)
WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy; Infectious Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy
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Zorzi, Antonella (författare)
WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy; Virology and Microbiology Unit, Department of Molecular Medicine, Padua University Hospital, Padua, Italy
Barbara, Christopher (författare)
Pathology Department, Mater Dei Hospital, Msida, Malta, Malta
Padovese, Valeska (författare)
Genitourinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta, L-Imsida, Malta, Malta
Hancali, Amina (författare)
Ministry of Health, National Institute of Hygiene, Rabat, Morocco
Oumzi, Hicham (författare)
National Institute of Hygiene, Ministry of Health, Rabat, Morocco
Kularatne, Ranmini (författare)
National Institute for Communicable Diseases, Johannesburg, South Africa
Jiang, Ting-Ting (författare)
Institute of Dermatology/Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China
Caceres, Carlos F. (författare)
Unit of Health, Sexuality and Human Development, Universidad Peruana Cayetano Heredia, Lima, Peru
Vargas, Silver (författare)
Laboratory of Sexual Health, Center for Interdisciplinary Research on Sexuality, AIDS and Society, Universidad Peruana Cayetano Heredia, Lima, Peru
Alvarez, Christian S. (författare)
Sida y Sociedad ONG (SISO), Escuintla, Guatemala
Camey, Elsy (författare)
Sida y Sociedad ONG (SISO), Escuintla, Guatemala
Peeling, Rosanna W. (författare)
Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK; Medical Microbiology Department, University of Manitoba, Winnipeg, Manitoba, Canada
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, Örebro University, Örebro, Sweden; Institute for Global Health, University College London (UCL), London, UK
Ballard, Ron (författare)
Consultant to WHO Headquarters - Geneva, The Villages, Florida, USA
Blondeel, Karel (författare)
Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
Kiarie, James (författare)
Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland
Thwin, Soe Soe (författare)
Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland
Toskin, Igor (författare)
Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland
ProSPeRo Network, - (bidragsgivare)
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 (creator_code:org_t)
2024
2024
Engelska.
Ingår i: BMJ Open. - 2044-6055. ; 14:6
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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  • INTRODUCTION: In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with 'gold-standard' reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries.METHOD AND ANALYSES: Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer's instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022.ETHICS AND DISSEMINATION: Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences.

Ämnesord

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

Nyckelord

Diagnostic microbiology
epidemiology
infectious diseases
public health

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