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

• Published in: BMC cardiovascular disorders Vol. 21; no. 1; p. 486
• Main Authors: Vetter, Beatrice, Beran, David, Boulle, Philippa, Chua, Arlene, de la Tour, Roberto, Hattingh, Lucy, Perel, Pablo, Roglic, Gojka, Sampath, Rangarajan, Woodman, Michael, Perone, Sigiriya Aebischer
• Format: Journal Article Conference Proceeding
• Language: English
• Published: England BioMed Central Ltd 09.10.2021; BioMed Central; BMC
• Subjects: Agreements; Biomarkers - blood; Blood Chemical Analysis - instrumentation; Blood Glucose - analysis; Cardiovascular disease; Cardiovascular diseases; Cardiovascular Diseases - blood; Cardiovascular Diseases - diagnosis; Care and treatment; Consensus; Creatinine; Creatinine - blood; Delphi Technique; Diabetes; Diabetes mellitus; Diabetes Mellitus - blood; Diabetes Mellitus - diagnosis; Diagnosis; Diagnostic equipment (Medical); Equipment and supplies; Equipment Design; Glycated Hemoglobin A - analysis; Health care; Humans; In vitro diagnostics; Infectious diseases; Kidney diseases; Laboratories; Lipids; Lipids - blood; Low- and middle-income country; Materials Testing; Medical device; Medical personnel; Metabolic diseases; Metabolic disorders; Metabolic Syndrome - blood; Metabolic Syndrome - diagnosis; Methods; Mortality; Point-of-Care Systems; Point-of-Care Testing; Polls & surveys; Predictive Value of Tests; Primary care; Primary Health Care; Product development; Questionnaires; Reagent Strips; Regulatory approval; Risk factors; Social sciences; Switzerland; In vitro diagnostics; Low- and middle-income country; Cardiovascular disease; Multi-parameter device; Medical device; Diabetes; Primary care
• ISSN: 1471-2261; 1471-2261
• DOI: 10.1186/s12872-021-02298-7

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). 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. 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. 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.