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Abstract：
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
摘要：
背景：2016年，世卫组织估计成年人中大约有3.74亿新感染以下四种可治愈的性传播感染（STIs）：衣原体（由沙眼衣原体（CT）引起），淋病（淋病奈瑟菌（NG）），梅毒（梅毒螺旋体）和滴虫（阴道毛滴虫（TV））。准确的护理点测试（POCT），用于筛查生殖器和生殖器外CT，NG和TV感染具有很大的价值，并且在最近十年中得到了发展。在基于实验室的研究中，与“黄金标准”参考测试相比，有几种测试在商业上可用，并显示出令人鼓舞的性能。然而,他们的临床表现数据有限，包括POC。重点人群,例如与男性发生性关系的男性（MSM），在生殖器和生殖器外部位有更高的性传播感染风险，并且这些性传播感染通常是无症状的，尤其是在外生殖器部位和女性中。Wewillconductaclinical-basedevaluationtoassessatetheperformancecharacteristicsandacceptabilitytoend-usersofthepoc/nearpatientuseoftheXpertCT/NG(Cepheid,桑尼维尔,加州,美国)生殖器筛查测试，MSM和XpertCT/NG和XpertTV的肛门直肠和咽部CT和NG感染（造父变星，桑尼维尔,加州,美国）用于生殖器CT筛查，与金标准参考核酸扩增测试相比，有这些性传播感染风险的女性的NG和TV。这个主协议概述了将在七个国家使用的总体研究方法。
方法：连续MSM和在临床地点出现的高危女性，低收入和中等收入国家将被注册。要评估的POCT是XpertCT/NG和XpertTV。所有程序将由训练有素的医护人员执行，并严格按照制造商的说明进行测试。敏感性,特异性，将计算每个POCT的阳性和阴性预测值。该研究正在进行中，预计将于2022年年中至2022年底在所有国家完成招聘。
背景：在注册之前，本核心方案由世卫组织性健康和生殖健康与研究部研究项目审查小组(RP2)和世卫组织伦理审查委员会(ERC)独立同行评审和批准.核心议定书已根据个别国家和RP2和ERC批准的改编进行了略微调整，以及每个参与地点的所有相关机构审查委员会。结果将通过同行评审的期刊传播，并在相关的国家/国际会议上发表。
方法：连续MSM和在临床地点出现的高危女性，低收入和中等收入国家将被注册。要评估的POCT是XpertCT/NG和XpertTV。所有程序将由训练有素的医护人员执行，并严格按照制造商的说明进行测试。敏感性,特异性，将计算每个POCT的阳性和阴性预测值。该研究正在进行中，预计将于2022年年中至2022年底在所有国家完成招聘。
背景：在注册之前，本核心方案由世卫组织性健康和生殖健康与研究部研究项目审查小组(RP2)和世卫组织伦理审查委员会(ERC)独立同行评审和批准.核心议定书已根据个别国家和RP2和ERC批准的改编进行了略微调整，以及每个参与地点的所有相关机构审查委员会。结果将通过同行评审的期刊传播，并在相关的国家/国际会议上发表。
