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Open Access 01-12-2024 | Research

Pre-market health systems barriers and enablers to infectious diseases point-of-care diagnostics in Australia: qualitative interviews with key informants

Authors: Lise Lafferty, Tanya L. Applegate, Sophie Lewis, Kerryn Drysdale, Robert Monaghan, Angela Kelly-Hanku, Rebecca Guy, Carla Treloar

Published in: BMC Infectious Diseases | Issue 1/2024

Abstract

Background

There exist multiple regulatory layers for point-of-care (POC) testing to be implemented within Australia. This qualitative analysis sought to understand the pre-market barriers and facilitators to scale-up infectious diseases POC testing in primary care settings at the national level.

Methods

Key informant interviews were undertaken with people (n = 30) working in high- level positions relevant to infectious diseases POC testing in Australia. Participants were recruited from federal and state health departments, industry, and nongovernment national peak bodies. The Unitaid scalability framework informed this analysis to understand barriers and enablers to creating access conditions and establishing country readiness for market access of POC tests.

Results

Participants identified regulatory frameworks as significant barriers to market access. National strategies and advocacy were viewed as potential enablers to establishing country readiness. It was recommended that the national system for universal health care should fund infectious disease POC tests to ensure financial sustainability, though the existing pathology infrastructure was regarded as a likely inhibitor.

Conclusions

Current regulatory frameworks inhibit market access for infectious disease POC testing devices for use in the primary care setting. National advocacy is urgently needed to gain government support and align national policies with regulatory frameworks.

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Title: Pre-market health systems barriers and enablers to infectious diseases point-of-care diagnostics in Australia: qualitative interviews with key informants
Authors: Lise Lafferty
Tanya L. Applegate
Sophie Lewis
Kerryn Drysdale
Robert Monaghan
Angela Kelly-Hanku
Rebecca Guy
Carla Treloar
Publication date: 01-12-2024
Publisher: BioMed Central
Published in: BMC Infectious Diseases / Issue 1/2024
Electronic ISSN: 1471-2334
DOI: https://doi.org/10.1186/s12879-024-10214-5

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Abstract

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