{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:07:08Z","timestamp":1792800428183,"version":"4.5.0"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,10,9]],"date-time":"2021-10-09T00:00:00Z","timestamp":1633737600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,10,9]],"date-time":"2021-10-09T00:00:00Z","timestamp":1633737600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"International Committee of the Red Cross","id":[{"id":"https:\/\/ror.org\/04h4t0r16","id-type":"ROR","asserted-by":"crossref"}]},{"DOI":"10.13039\/100009131","name":"Swiss Agency for Development and Cooperation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100009131","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Cardiovasc Disord"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u2009\u2264\u200985% in either the survey or among interviewees were further discussed by the expert group and amended as appropriate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty people responded to the online survey and 18 experts participated in the interviews. Twenty-two characteristics had an agreement level of\u2009\u2264\u200985% 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12872-021-02298-7","type":"journal-article","created":{"date-parts":[[2021,10,10]],"date-time":"2021-10-10T16:10:55Z","timestamp":1633882255000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Development of a target product profile for a point-of-care cardiometabolic device"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7898-472X","authenticated-orcid":false,"given":"Beatrice","family":"Vetter","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Beran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippa","family":"Boulle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arlene","family":"Chua","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"de la Tour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Hattingh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"Perel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gojka","family":"Roglic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rangarajan","family":"Sampath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Woodman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigiriya Aebischer","family":"Perone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,10,9]]},"reference":[{"issue":"4","key":"2298_CR1","doi-asserted-by":"publisher","first-page":"393","DOI":"10.1016\/j.gheart.2016.10.024","volume":"11","author":"CP Benziger","year":"2016","unstructured":"Benziger CP, Roth GA, Moran AE. The global burden of disease study and the preventable burden of NCD. Glob Heart. 2016;11(4):393\u20137.","journal-title":"Glob Heart"},{"key":"2298_CR2","unstructured":"World Health Organization (WHO). Noncommunicable diseases: Country profiles 2018, https:\/\/www.who.int\/nmh\/publications\/ncd-profiles-2018\/en\/. Accessed 18 December 2020."},{"issue":"11","key":"2298_CR3","doi-asserted-by":"publisher","first-page":"1667","DOI":"10.1038\/s41591-019-0644-7","volume":"25","author":"JJ Miranda","year":"2019","unstructured":"Miranda JJ, Barrientos-Gutierrez T, Corvalan C, Hyder AA, Lazo-Porras M, Oni T, Wells JCK. Understanding the rise of cardiometabolic diseases in low- and middle-income countries. Nat Med. 2019;25(11):1667\u201379.","journal-title":"Nat Med"},{"key":"2298_CR4","unstructured":"World Health Organization (WHO). Noncommunicable diseases: key facts, https:\/\/www.who.int\/en\/news-room\/fact-sheets\/detail\/noncommunicable-diseases. 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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.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"486"}}