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Review
. 2024 Dec 19;9(4):208-218.
doi: 10.3138/jammi-2024-0008. eCollection 2024 Dec.

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

Kathleen Whyte  1 , Andrea Chittle  2 , Raymond Sw Tsang  1
Affiliations
Review

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

Kathleen Whyte et al. J Assoc Med Microbiol Infect Dis Can. .

Abstract
in English, French

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.

Au début des années 2000, le taux de syphilis infectieuse a commencé à augmenter au Canada. Depuis le milieu des années 2010, le taux chez les femmes, notamment celles en âge de procréer, s'est accru rapidement. Conjointement à ce phénomène, les cas de syphilis congénitale sont réapparus au Canada ces dernières années. La syphilis infectieuse et congénitale atteint démesurément les communautés touchées par des déterminants sociaux et structurels de la santé, y compris l'itinérance et des services de santé inappropriés ou inaccessibles. Ces réalités font ressortir l'importance de stratégies émergentes, y compris les tests diagnostiques rapides qui peuvent être utilisés au point de service, et servir d'outils pour renverser ces tendances. Un meilleur accès aux tests fait partie des piliers du Cadre d'action pancanadien sur les infections transmissibles sexuellement et par le sang (ITSS) et le Plan d'action 2024-2030 du gouvernement du Canada sur les ITSS. La Direction générale du Laboratoire national de microbiologie de l'Agence de la santé publique du Canada s'est affairée à lancer des tests de diagnostic rapide, y compris des tests au point de service (PDS) pour le dépistage des ITSS. Puisque Santé Canada a approuvé un premier test de la syphilis au PDS (test INSTI multiplex de détection des anticorps anti-VIH-1/VIH-2/syphilis de bioLytical) en 2023, le temps est venu de réfléchir aux considérations importantes relatives à la mise en œuvre de ce test et d'autres tests de la syphilis au PDS au Canada. Dans le présent article, les auteurs visent à examiner les tests au PDS offerts sur le marché pour détecter les anticorps de la syphilis, leur rendement dans de récentes études sur le terrain et les considérations contextuelles clés que doit envisager le Canada pour mettre en œuvre les tests de la syphilis au PDS.

Keywords: Canada; Treponema pallidum; implementation; infectious syphilis; point-of-care testing.

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Conflict of interest statement

All authors are employees of the Public Health Agency of Canada. K Whyte and RSW Tsang participate in evaluation of syphilis POCTs. The authors have no other conflict of interest to declare. Also, the opinions expressed in this work are those of the authors and they do not represent the official position of the National Microbiology Laboratory Branch or the Public Health Agency of Canada. Specific products mentioned in this manuscript are for discussion purposes only and not to be construed as an endorsement or recommendation by the authors, the National Microbiology Laboratory Branch, or the Public Health Agency of Canada.

References

    1. Health Canada. Proceedings of National STD Consensus Meeting and National Goals for the Prevention and Control of Sexually Transmitted Diseases in Canada. Can Commun Dis Rep. 1997;23(S6):1–15.
    1. Aho J, Lybeck C, Tetteh A, et al. Rising syphilis rates in Canada, 2011-2020. Can Commun Dis Rep. 2022;48(2/3):52–60. 10.14745/ccdr.v48i23a01. PMID: - DOI - PMC - PubMed
    1. Centers for Disease Control and Prevention. National overview – sexually transmitted disease surveillance, 2019. 2021; https://www.cdc.gov/std/statistics/2019/std-surveillance-2019.pdf. Accessed November 6, 2023.
    1. Kirby Institute, University of South Wales. Sexually transmissible infections. https://data.kirby.unsw.edu.au/STIs. Accessed: November 6, 2023.
    1. Public Health Agency of Canada. Infographic: infectious syphilis and congenital syphilis in Canada, 2022. Can Commun Dis Rep. 2023;49(10):439.

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