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. 2021 Oct 9;21(1):486.
doi: 10.1186/s12872-021-02298-7.

Development of a target product profile for a point-of-care cardiometabolic device

Beatrice Vetter  1 , David Beran  2 , Philippa Boulle  3 , Arlene Chua  3 , Roberto de la Tour  3 , Lucy Hattingh  4 , Pablo Perel  5 , Gojka Roglic  6 , Rangarajan Sampath  7 , Michael Woodman  8 , Sigiriya Aebischer Perone  2   9
Affiliations

Development of a target product profile for a point-of-care cardiometabolic device

Beatrice Vetter et al. BMC Cardiovasc Disord. .

Abstract

Introduction: Multi-parameter diagnostic devices can simplify cardiometabolic disease diagnosis. However, existing devices may not be suitable for use in low-resource settings, where the burden of non-communicable diseases is high. Here we describe the development of a target product profile (TPP) for a point-of-care multi-parameter device for detection of biomarkers for cardiovascular disease and metabolic disorders, including diabetes, in primary care settings in low- and middle-income countries (LMICs).

Methods: A draft TPP developed by an expert group was reviewed through an online survey and semi-structured expert interviews to identify device characteristics requiring refinement. The draft TPP included 41 characteristics with minimal and optimal requirements; characteristics with an agreement level for either requirement of ≤ 85% in either the survey or among interviewees were further discussed by the expert group and amended as appropriate.

Results: Twenty people responded to the online survey and 18 experts participated in the interviews. Twenty-two characteristics had an agreement level of ≤ 85% in either the online survey or interviews. The final TPP defines the device as intended to be used for basic diagnosis and management of cardiometabolic disorders (lipids, glucose, HbA1c, and creatinine) as minimal requirement, and offering an expanded test menu for wider cardiometabolic disease management as optimal requirement. To be suitable, the device should be intended for level 1 healthcare settings or lower, used by minimally trained healthcare workers and allow testing using self-contained cartridges or strips without the need for additional reagents. Throughput should be one sample at a time in a single or multi-analyte cartridge, or optimally enable testing of several samples and analytes in parallel with random access.

Conclusion: This TPP will inform developers of cardiometabolic multi-parameter devices for LMIC settings, and will support decision makers in the evaluation of existing and future devices.

Keywords: Cardiovascular disease; Diabetes; In vitro diagnostics; Low- and middle-income country; Medical device; Multi-parameter device; Primary care.

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Conflict of interest statement

LH reports personal fees from Roche Diagnostics, personal fees from Bio-Rad Laboratories, and personal fees from Becton–Dickinson and Company, outside the submitted work. BV and RS declare that they are employed by the Foundation for Innovative New Diagnostics (FIND). All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Results from the online survey and semi-structured interviews
Fig. 2
Fig. 2
Most important device characteristics for: a clinicians and users (N = 13); b purchase decision makers (N = 12)
See this image and copyright information in PMC

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