{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T02:10:54Z","timestamp":1768270254268,"version":"3.49.0"},"reference-count":27,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2016,1,7]],"date-time":"2016-01-07T00:00:00Z","timestamp":1452124800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Tropical Med Int Health"],"published-print":{"date-parts":[[2016,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The prevalence of hyperlipidaemia, along with other non\u2010communicable diseases, is on the rise in low\u2010 and middle\u2010income countries. CardioChek <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content> is a point\u2010of\u2010care lipid measuring device, which seeks to overcome laboratory\u2010based diagnostic barriers by providing immediate results without dependency on significant laboratory infrastructure. However, it has not been validated in Kenya. In this study, we assess the accuracy of CardioChek <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content> with respect to the gold standard laboratory\u2010based testing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In Webuye, Kenya, two blood samples were collected from 246 subjects to simultaneously measure the lipid levels via both CardioChek <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content> and the gold standard. All subjects were adults, and geographic stratified sampling methods were applied. Statistical analysis of the device's accuracy was based on per cent bias parameters, as established by the United States National Institutes of Health (<jats:styled-content style=\"fixed-case\">NIH<\/jats:styled-content>). The <jats:styled-content style=\"fixed-case\">NIH<\/jats:styled-content> recommends that per cent bias be \u2264\u00b13% for low\u2010density lipoprotein (<jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>) cholesterol, \u2264\u00b15% for high\u2010density lipoprotein (<jats:styled-content style=\"fixed-case\">HDL<\/jats:styled-content>) cholesterol, \u2264\u00b15% for total cholesterol (<jats:styled-content style=\"fixed-case\">TC<\/jats:styled-content>) and \u2264\u00b14% for triglycerides (<jats:styled-content style=\"fixed-case\">TG<\/jats:styled-content>). Risk group misclassification rates were also analysed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The CardioChek <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content> analyzer was substantially inaccurate for <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content> cholesterol (\u221225.9% bias), <jats:styled-content style=\"fixed-case\">HDL<\/jats:styled-content> cholesterol (\u22128.2% bias) and <jats:styled-content style=\"fixed-case\">TC<\/jats:styled-content> (\u221215.9% bias). Moreover, those patients at higher risk of complications from hyperlipidaemia were most likely to be misclassified into a lower risk category.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>CardioChek <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content> is inaccurate and not suitable for our clinical setting. Furthermore, our findings highlight the need to validate new diagnostic tools in the appropriate setting prior to scale up regardless of their potential for novel utility.<\/jats:p><\/jats:sec>","DOI":"10.1111\/tmi.12653","type":"journal-article","created":{"date-parts":[[2015,12,11]],"date-time":"2015-12-11T08:29:47Z","timestamp":1449822587000},"page":"437-444","source":"Crossref","is-referenced-by-count":15,"title":["Assessing the accuracy of a point\u2010of\u2010care analyzer for hyperlipidaemia in western <scp>K<\/scp>enya"],"prefix":"10.1111","volume":"21","author":[{"given":"Paul H.","family":"Park","sequence":"first","affiliation":[{"name":"Duke Global Health Institute Duke University Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Chege","sequence":"additional","affiliation":[{"name":"Department of Family Medicine School of Medicine College of Health Sciences Moi University Eldoret 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