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

Content Provider	Springer Nature : BioMed Central
Author	Lafferty, Lise Applegate, Tanya L. Lewis, Sophie Drysdale, Kerryn Monaghan, Robert Kelly-Hanku, Angela Guy, Rebecca Treloar, Carla
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.
Related Links	https://bmcinfectdis.biomedcentral.com/counter/pdf/10.1186/s12879-024-10214-5.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14712334
DOI	10.1186/s12879-024-10214-5
Journal	BMC Infectious Diseases
Issue Number	1
Volume Number	24
Language	English
Publisher	BioMed Central
Publisher Date	2024-11-19
Access Restriction	Open
Subject Keyword	Infectious Diseases Parasitology Medical Microbiology Tropical Medicine Internal Medicine Point-of-care testing Qualitative research Regulatory frameworks Sustainability
Content Type	Text
Resource Type	Article
Subject	Infectious Diseases
Journal Impact Factor	3.4/2023
5-Year Journal Impact Factor	3.3/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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