logo
Science Portal
Copyright © Médecins Sans Frontières
v2.1.5115.produseast1
About MSF Science Portal
About
Contact Us
Frequently Asked Questions (FAQs)
Privacy Policy
Terms of Use
Copyright © Médecins Sans Frontières
v2.1.5115.produseast1
Development of a target product profile for a point-of-care cardiometabolic device | Journal Article / Research | MSF Science Portal
Journal Article
|Research

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

Vetter B, Beran D, Boulle P, Chua AC, de la Tour R, Hattingh L, Perel P, Roglic G, Sampath R, Woodman M, Perone SA
Download

Similar Content
Loading...
Loading...
Loading...
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.

RESULT
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.

CONCLUSIONS
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.

Subject Area

models of carecardiovascular disease

Languages

English
DOI
10.1186/s12872-021-02298-7
Published Date
09 Oct 2021
PubMed ID
34627153
Journal
BMC Cardiovascular Disorders
Volume | Issue | Pages
Volume 21, Pages 486
Dimensions Badge