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梅毒即时检验(POCT):加拿大的实施考量

Syphilis Point-of-Care Tests (POCTs): Implementation Considerations in Canada.

作者信息

Whyte Kathleen, Chittle Andrea, Tsang Raymond Sw

机构信息

Laboratory for Syphilis Diagnostics, National Microbiology Laboratory Branch, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.

Sexually Transmitted and Blood-Borne Infections Surveillance Division, Public Health Agency of Canada, Guelph, Ontario, Canada.

出版信息

J Assoc Med Microbiol Infect Dis Can. 2024 Dec 19;9(4):208-218. doi: 10.3138/jammi-2024-0008. eCollection 2024 Dec.

Abstract

Starting in the early 2000s, the rate of infectious syphilis in Canada began rising. Since the mid-2010s, the rate among females, particularly females in their reproductive years, has increased rapidly. Coincident with this shift, congenital syphilis has re-emerged in Canada in recent years. Infectious and congenital syphilis disproportionately impact communities affected by social and structural determinants of health, including homelessness and inadequate or inaccessible health care services. These realities underscore the importance of emerging strategies, including rapid diagnostic tests that can be deployed at the point of care, as tools to help reverse these trends. Increased access to testing is one of the pillars of the Pan-Canadian Framework for Action on Sexually Transmitted and Blood-Borne Infections (STBBI) and the Government of Canada's STBBI Action Plan 2024-2030. The National Microbiology Laboratory Branch of the Public Health Agency of Canada has worked towards introducing rapid diagnostic tests including point-of-care tests (POCTs) for STBBI testing. With Health Canada's first approval of a syphilis POCT (bioLytical's INSTI MULTIPLEX HIV-1/2 Syphilis Ab Test) in 2023, it is timely to reflect on important implementation considerations for this and other syphilis POCTs in Canada. In this article, we aim to review antibody-detecting syphilis POCTs that are commercially available, their performance in recent Canadian field studies, and key contextual considerations for Canada in implementing POCTs for syphilis.

摘要

从21世纪初开始,加拿大的传染性梅毒发病率开始上升。自2010年代中期以来,女性尤其是育龄女性中的发病率迅速上升。与此同时,近年来先天性梅毒在加拿大再度出现。传染性梅毒和先天性梅毒对受健康的社会和结构决定因素影响的社区造成了不成比例的影响,这些因素包括无家可归以及医疗保健服务不足或难以获得。这些现实凸显了新兴策略的重要性,包括可在护理点使用的快速诊断测试,作为有助于扭转这些趋势的工具。增加检测机会是《加拿大性传播和血源感染行动框架》以及加拿大政府《2024-2030年性传播和血源感染行动计划》的支柱之一。加拿大公共卫生署国家微生物学实验室分部一直致力于引入快速诊断测试,包括用于性传播和血源感染检测的即时检验(POCT)。随着加拿大卫生部在2023年首次批准一种梅毒POCT(生物分析公司的INSTI MULTIPLEX HIV-1/2梅毒抗体检测),现在是时候思考该检测以及加拿大其他梅毒POCT的重要实施考量因素了。在本文中,我们旨在回顾市面上可买到的检测抗体的梅毒POCT、它们在加拿大近期现场研究中的表现,以及加拿大在实施梅毒POCT方面的关键背景考量因素。

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