Abstract：
Intense transmission of syphilis has emerged in some Canadian Arctic communities despite screening and prevention efforts. The remoteness of most communities and limited diagnostic infrastructure yield long delays (≥14 days) between screening and treatment of cases. These hamper syphilis control efforts and may contribute to sustained transmission. Syphilis rapid diagnostic tests (RDTs) have been developed to make screening more accessible and to inform clinical decision-making within the same clinical encounter. These RDTs have been successfully deployed in several countries, but not yet in Canada.
We describe the methodology of the \"Stopping Syphilis Transmission in Arctic Communities Through Rapid Diagnostic Testing\" (STAR) study, wherein the clinical and epidemiological impact of deploying a dual syphilis RDT in the context of ongoing transmission in Nunavut and Nunavik will be evaluated. In this prospective multisite field evaluation, sexually active individuals aged ≥14 years at risk for syphilis will be offered screening by an RDT at the point-of-care by non-laboratory trained registered nurses. Whole blood and serum specimens will be concurrently collected, when feasible, for rapid testing with an RDT containing both treponemal and non-treponemal components (Chembio DPP® Syphilis Screen & Confirm) and compared to laboratory-based reference testing according to a reverse sequence algorithm. The diagnostic accuracy of the RDT, using both whole blood and centrifuged serum specimens, will be validated under real-world conditions in remote Northern settings, outside of specialized laboratories. Additionally, screening-to-treatment time, case detection rates, and the number of infectious contacts averted by using the RDT relative to reference testing will be estimated. The impact of both diagnostic approaches on syphilis transmission dynamics will also be modeled.
This study will provide much needed evidence for strengthening rapid responses to emerging syphilis outbreaks in remote Arctic regions, by supplementing traditional diagnostic strategies with an RDT to rapidly triage patients likely in need of treatment. These results will also inform the development and tailoring of future diagnostic strategies and public health responses to emerging outbreaks in the North.
We describe the methodology of the \"Stopping Syphilis Transmission in Arctic Communities Through Rapid Diagnostic Testing\" (STAR) study, wherein the clinical and epidemiological impact of deploying a dual syphilis RDT in the context of ongoing transmission in Nunavut and Nunavik will be evaluated. In this prospective multisite field evaluation, sexually active individuals aged ≥14 years at risk for syphilis will be offered screening by an RDT at the point-of-care by non-laboratory trained registered nurses. Whole blood and serum specimens will be concurrently collected, when feasible, for rapid testing with an RDT containing both treponemal and non-treponemal components (Chembio DPP® Syphilis Screen & Confirm) and compared to laboratory-based reference testing according to a reverse sequence algorithm. The diagnostic accuracy of the RDT, using both whole blood and centrifuged serum specimens, will be validated under real-world conditions in remote Northern settings, outside of specialized laboratories. Additionally, screening-to-treatment time, case detection rates, and the number of infectious contacts averted by using the RDT relative to reference testing will be estimated. The impact of both diagnostic approaches on syphilis transmission dynamics will also be modeled.
This study will provide much needed evidence for strengthening rapid responses to emerging syphilis outbreaks in remote Arctic regions, by supplementing traditional diagnostic strategies with an RDT to rapidly triage patients likely in need of treatment. These results will also inform the development and tailoring of future diagnostic strategies and public health responses to emerging outbreaks in the North.
摘要：
尽管进行了筛查和预防工作，但加拿大的一些北极社区仍出现了梅毒的强烈传播。大多数社区的偏远和有限的诊断基础设施导致筛查和治疗病例之间的长时间延迟（≥14天）。这些阻碍了梅毒的控制努力，并可能有助于持续传播。已经开发了梅毒快速诊断测试（RDT），以使筛查更容易获得，并在相同的临床经历中为临床决策提供信息。这些RDT已经在几个国家成功部署,但还没有在加拿大。
我们描述了“通过快速诊断测试阻止北极社区梅毒传播”（STAR）研究的方法，其中将评估在努纳武特和努纳维克持续传播的背景下部署双重梅毒RDT的临床和流行病学影响。在这个前瞻性的多站点现场评估中，年龄≥14岁有梅毒风险的性活跃个体将由RDT在非实验室培训的注册护士的护理点进行筛查.同时采集全血和血清标本,在可行的情况下，用于使用包含螺旋体和非螺旋体成分的RDT进行快速测试（ChembioDPP®梅毒筛查和确认），并根据反向序列算法与基于实验室的参考测试进行比较。RDT的诊断准确性，使用全血和离心血清标本，将在遥远的北方环境中在现实世界的条件下进行验证，在专业实验室之外。此外,筛查至治疗时间，病例检出率，并且将估计通过使用RDT相对于参考测试避免的感染性接触者的数量。两种诊断方法对梅毒传播动力学的影响也将被建模。
这项研究将为加强对北极偏远地区新出现的梅毒暴发的快速反应提供急需的证据。通过用RDT补充传统的诊断策略来快速分诊可能需要治疗的患者。这些结果还将为制定和调整未来的诊断策略以及针对北方新出现的疫情的公共卫生应对措施提供信息。
我们描述了“通过快速诊断测试阻止北极社区梅毒传播”（STAR）研究的方法，其中将评估在努纳武特和努纳维克持续传播的背景下部署双重梅毒RDT的临床和流行病学影响。在这个前瞻性的多站点现场评估中，年龄≥14岁有梅毒风险的性活跃个体将由RDT在非实验室培训的注册护士的护理点进行筛查.同时采集全血和血清标本,在可行的情况下，用于使用包含螺旋体和非螺旋体成分的RDT进行快速测试（ChembioDPP®梅毒筛查和确认），并根据反向序列算法与基于实验室的参考测试进行比较。RDT的诊断准确性，使用全血和离心血清标本，将在遥远的北方环境中在现实世界的条件下进行验证，在专业实验室之外。此外,筛查至治疗时间，病例检出率，并且将估计通过使用RDT相对于参考测试避免的感染性接触者的数量。两种诊断方法对梅毒传播动力学的影响也将被建模。
这项研究将为加强对北极偏远地区新出现的梅毒暴发的快速反应提供急需的证据。通过用RDT补充传统的诊断策略来快速分诊可能需要治疗的患者。这些结果还将为制定和调整未来的诊断策略以及针对北方新出现的疫情的公共卫生应对措施提供信息。
