Abstract
IntroductionMulti-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).MethodsA 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.ResultsTwenty 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.ConclusionThis 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.
Highlights
Multi-parameter diagnostic devices can simplify cardiometabolic disease diagnosis
Background non-communicable diseases (NCDs) are often thought to be a problem of high income countries, a large proportion of the burden of Non-communicable disease (NCD) is borne by lowand middle-income countries (LMICs), with 78% of all
Cardiovascular diseases (CVDs) and metabolic disorders represent a large proportion of the NCD burden in Low- and middle income country (LMIC) [3, 4], with stroke, ischaemic heart disease, diabetes and chronic kidney disease commonly appearing in the top ten causes of life years lost due to premature mortality [5]
Summary
Existing devices may not be suitable for use in low-resource settings, where the burden of non-communicable diseases is high. Cardiovascular diseases (CVDs) and metabolic disorders represent a large proportion of the NCD burden in LMICs [3, 4], with stroke, ischaemic heart disease, diabetes and chronic kidney disease commonly appearing in the top ten causes of life years lost due to premature mortality [5]. With its emphasis on promoting health and preventing disease, is the most effective way to reduce premature mortality from NCDs [6, 7], but many primary healthcare facilities in LMICs lack the laboratory capacity required for diagnosis and monitoring of these conditions [8]. While several multi-parameter devices for CVDs already exist, they may not be suitable for use in LMICs due to resource requirements (e.g. power, storage), the need for trained users, and environmental operating conditions [11]
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