Development of a target product profile for a point-of-care cardiometabolic device
| Autor: | Sigiriya Aebischer Perone, Michael Woodman, Gojka Roglic, Roberto de la Tour, David Beran, Pablo Perel, Lucy Hattingh, Arlene Chua, Philippa Boulle, Rangarajan Sampath, Beatrice N. Vetter |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Blood Glucose
Consensus Delphi Technique Point-of-Care Systems Sample (statistics) Primary care Disease Low- and middle-income country Predictive Value of Tests Health care Materials Testing Diabetes Mellitus Medicine Diseases of the circulatory (Cardiovascular) system Humans Point of care Medical device Reagent Strips Glycated Hemoglobin Metabolic Syndrome Primary Health Care business.industry Research Product profile Diabetes Equipment Design medicine.disease Cardiovascular disease Lipids Test (assessment) Multi-parameter device Cardiovascular Diseases Point-of-Care Testing RC666-701 Creatinine Medical emergency Cardiology and Cardiovascular Medicine business Random access Biomarkers Blood Chemical Analysis In vitro diagnostics |
| Zdroj: | BMC Cardiovascular Disorders BMC Cardiovascular Disorders, Vol 21, Iss 1, Pp 1-13 (2021) |
| ISSN: | 1471-2261 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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