Naidu Prenilla, Tsang Raymond Sw
Provincial Laboratory for Public Health, Edmonton, Alberta, Canada.
Syphilis Diagnostic Unit, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
J Assoc Med Microbiol Infect Dis Can. 2022 Jun 3;7(2):85-96. doi: 10.3138/jammi-2021-0021. eCollection 2022 Jun.
Over the past few years, the increase in infectious syphilis outbreaks in major urban centres and remote or rural locations in Canada, often affecting hard-to-reach patient populations, has renewed an interest and urgency in studying the use of point-of-care tests (POCTs) that can provide test results at the time and place of primary health care delivery, obviating the repeat visit necessary with traditional syphilis serology or molecular diagnostic tests. In 2015, the Canadian Public Health Laboratory Network released its first laboratory guideline for the use of POCTs in the diagnosis of syphilis in Canada. Although Canada has no licensed POCT, two POCTs (Syphilis Health Check and the DPP® HIV Syphilis System) have received US Food and Drug Administration (FDA) approval under premarket approval applications. Most syphilis POCTs detect antibodies to treponemal antigens, so their results cannot be used to differentiate between active and past infection. The only POCT that detects antibodies to both treponemal and non-treponemal antigens does not yet have Health Canada or FDA approval. In this updated guideline, the current landscape of POCTs for syphilis, with an emphasis on data from low-prevalence countries, is described. Individual operators should consider the questions of where, when, how, and why a POCT is used before its actual implementation. Training in the operation and interpretation, quality control, proficiency program, safety, and careful documentation of the process and results are especially important for the successful implementation of POCTs.
在过去几年中，加拿大主要城市中心以及偏远或农村地区的感染性梅毒疫情不断增加，这些疫情往往影响到难以接触到的患者群体，这重新引发了人们对即时检验（POCT）的兴趣，并凸显了其紧迫性。即时检验能够在初级卫生保健提供的时间和地点提供检测结果，从而避免了传统梅毒血清学或分子诊断检测所需的再次就诊。2015年，加拿大公共卫生实验室网络发布了其首份关于在加拿大使用即时检验诊断梅毒的实验室指南。尽管加拿大没有获得许可的即时检验产品，但有两种即时检验产品（梅毒健康检查和DPP® HIV梅毒检测系统）已根据上市前批准申请获得了美国食品药品监督管理局（FDA）的批准。大多数梅毒即时检验产品检测针对梅毒螺旋体抗原的抗体，因此其结果不能用于区分现症感染和既往感染。唯一一种能同时检测针对梅毒螺旋体和非梅毒螺旋体抗原抗体的即时检验产品尚未获得加拿大卫生部或FDA批准。在本更新指南中，描述了梅毒即时检验的现状，重点介绍了来自低流行率国家的数据。在实际实施即时检验之前，个体操作人员应考虑在何处、何时、如何以及为何使用即时检验的问题。对于即时检验的成功实施而言，操作与解读、质量控制、能力验证计划、安全性以及对过程和结果进行仔细记录等方面的培训尤为重要。
