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.

"Declarations Ethics approval and consent to participateThe core protocol upon which this study was based was independently peer reviewed and approved by the Research Project Review Panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research (SRH) and by the WHO Ethics Review Committee (ERC). The protocol has also been adapted to the individual countries and approved by RP2, ERC, and institutional review boards at each site. Details are provided in elsewhere [27]. Consent for publicationNot applicable. Competing interestsThe POCT manufacturer disclose and furnish free of charge to WHO the information and sufficient quantities of the product in order to enable this evaluation as part of the WHO/RHR STI POC initiative. WHO is entitled to evaluate and publish the trial results, and to exclusively control this evaluation and the content of the aforesaid publication. WHO shall submit any proposed publication to the manufacturers for review, comments received will be considered in good faith, but the decision to publish rests with WHO. Competing interests The POCT manufacturer disclose and furnish free of charge to WHO the information and sufficient quantities of the product in order to enable this evaluation as part of the WHO/RHR STI POC initiative. WHO is entitled to evaluate and publish the trial results, and to exclusively control this evaluation and the content of the aforesaid publication. WHO shall submit any proposed publication to the manufacturers for review, comments received will be considered in good faith, but the decision to publish rests with WHO."

"Funding This work received funding from the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a co-sponsored programme executed by the World Health Organization (WHO) and the Government of Canada."