{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T17:49:00Z","timestamp":1779299340340,"version":"3.51.4"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,7,11]],"date-time":"2025-07-11T00:00:00Z","timestamp":1752192000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000191","name":"Kidney Foundation of Canada","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000191","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005565","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005565","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008794","name":"Research Manitoba","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008794","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical Co., Ltd","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Tricida"},{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Albuminuria is an important biomarker for detecting chronic kidney disease (CKD), particularly in at-risk individuals. Advances in diagnostic technology have introduced home-use, semiquantitative testing methods such as the FDA-cleared Minuteful Kidney Test (MKT). This study compares the diagnostic accuracy of the MKT to the Beckman Coulter AU 480 analyzer, a standard laboratory quantitative method, for detecting albuminuria in individuals with or at risk for CKD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Urine samples were obtained from individuals with risk factors for kidney damage. Each sample was analyzed for the urinary albumin-to-creatinine ratio (uACR) using both the MKT and the laboratory standard method. Albuminuria was classified according to KDIGO guidelines: A1 (uACR &amp;lt;30\u2005mg\/g, \u201cnormal to mildly increased\u201d), A2 (uACR 30\u2013300\u2005mg\/g, \u201cmoderately increased\u201d), and A3 (uACR &amp;gt;300\u2005mg\/g, \u201cseverely increased\u201d). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MKT were calculated against the laboratory standard.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Out of 615 collected urine samples, 555 met inclusion criteria. Albuminuria (uACR &amp;gt;30\u2005mg\/g) was detected in 24.9% of samples using the laboratory method (95% CI: 21.3%\u201328.5%). The MKT demonstrated a sensitivity of 96.4%, specificity of 84.2%, NPV of 98.6%, and PPV of 66.8%. MKT accurately categorized 85.6% of samples into the KDIGO albuminuria categories A1, A2, and A3, identifying 100% of laboratory-confirmed A3 samples as abnormal.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The MKT shows high sensitivity, exceeding the guideline-required threshold (&amp;gt;85%, P &amp;lt; 0.001), and acceptable specificity for detecting albuminuria in high-risk populations. This device offers the potential to improve CKD detection and management and facilitate early intervention in primary care and community settings, where accurate rule-out capabilities are essential.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jalm\/jfaf087","type":"journal-article","created":{"date-parts":[[2025,7,11]],"date-time":"2025-07-11T11:11:38Z","timestamp":1752232298000},"page":"1241-1253","source":"Crossref","is-referenced-by-count":5,"title":["Diagnostic Accuracy of Smartphone-Enabled Urinary Albumin-to-Creatinine Ratio Testing"],"prefix":"10.1093","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6219-3675","authenticated-orcid":false,"given":"Danielle","family":"Jeddah","sequence":"first","affiliation":[{"name":"Department of Clinical Development, Healthy.io , Boston, MA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas B","family":"Bevins","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, BirdRock Laboratories , San Diego, CA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matan","family":"Ronen","sequence":"additional","affiliation":[{"name":"Department of Clinical Development, Healthy.io , Boston, MA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ron","family":"Zohar","sequence":"additional","affiliation":[{"name":"Department of Clinical Development, Healthy.io , Boston, MA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Navdeep","family":"Tangri","sequence":"additional","affiliation":[{"name":"Department of Medicine, and the Department of Community Health Sciences, Max Rady College of Medicine, University of Manitoba , Winnipeg, MB ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,7,11]]},"reference":[{"key":"2025090311543494400_jfaf087-B1","doi-asserted-by":"crossref","first-page":"2025","DOI":"10.2337\/dc21-0723","article-title":"Chronic kidney disease testing among at-risk adults in the U.S. remains low: real-world evidence from a national laboratory database","volume":"44","author":"Alfego","year":"2021","journal-title":"Diabetes Care"},{"key":"2025090311543494400_jfaf087-B2","doi-asserted-by":"crossref","first-page":"975","DOI":"10.1016\/j.mayocp.2020.07.037","article-title":"Adherence to chronic kidney disease screening guidelines among patients with type 2 diabetes in a US administrative claims database","volume":"96","author":"Folkerts","year":"2021","journal-title":"Mayo Clin Proc"},{"key":"2025090311543494400_jfaf087-B3","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1038\/ki.2010.531","article-title":"Lower 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