Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Nov 19;24(1):1317.
doi: 10.1186/s12879-024-10214-5.

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

Lise Lafferty  1   2 , Tanya L Applegate  3 , Sophie Lewis  4 , Kerryn Drysdale  5 , Robert Monaghan  3 , Angela Kelly-Hanku  3 , Rebecca Guy  3 , Carla Treloar  5
Affiliations

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

Lise Lafferty et al. BMC Infect Dis. .

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.

Keywords: Infectious diseases; Point-of-care testing; Qualitative research; Regulatory frameworks; Sustainability.

PubMed Disclaimer

Conflict of interest statement

Declarations Ethics approval and consent to participate Ethics approvals were obtained from: University of New South Wales Human Research Ethics Committee (HC200472), and Australian Institute of Aboriginal and Torres Strait Islander Studies Research Ethics Committee (EO209-20201002). The Participant Information Statement was attached to the initial email invitation and reviewed with participants prior to interview commencement. Informed verbal consent was obtained from all participants prior to commencement of interviews. Consent for publication Consent for publication was included in the Participant Information Statement. All participants gave informed consent to participate prior to interview commencement; consent included consent to publish quotes from de-identified transcripts. Additionally, all participants whose quotes were selected for use within this manuscript were given the opportunity to approve/deny inclusion of excerpts via email (none rejected). Competing interests LL, TLA, SL, KD, RM, and CT do not have any competing interests relevant to this study. AK-H has received speaker fees from Cepheid. RG leads two independent grants from National Health and Medical Research Council and Australian Research Council which receive funding and in-kind from Cepheid.

Similar articles

See all similar articles

References

    1. Chen H, Liu K, Li Z, Wang P. Point of care testing for infectious diseases. Clin Chim Acta. 2019;493:138–47. 10.1016/j.cca.2019.03.008. - PMC - PubMed
    1. Price CP, Kricka LJ. Improving Healthcare accessibility through point-of-Care technologies. Clin Chem. 2007;53(9):1665–75. 10.1373/clinchem.2006.084707. - PubMed
    1. Drain PK, Hyle EP, Noubary F, Freedberg KA, Wilson D, Bishai WR, Bassett IV. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis. 2014;14(3):239–49. 10.1016/S1473-3099(13)70250-0. - PMC - PubMed
    1. Peeling RW, McNerney R. Emerging technologies in point-of-care molecular diagnostics for resource-limited settings. Expert Rev Mol Diagn. 2014;14(5):525–34. 10.1586/14737159.2014.915748. - PubMed
    1. World Health Organization. Diagnostic errors: Technical Series on Safer Primary Care. Geneva: World Health Organization; 2016.

LinkOut - more resources