{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:52:15Z","timestamp":1791276735772,"version":"4.1.0"},"reference-count":42,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:00:00Z","timestamp":1791244800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:00:00Z","timestamp":1791244800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100013254","name":"National College Students Innovation and Entrepreneurship Training Program","doi-asserted-by":"publisher","award":["202516405001S"],"award-info":[{"award-number":["202516405001S"]}],"id":[{"id":"10.13039\/501100013254","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cystatin\u2010C is an important renal function biomarker, but conventional quantification requires centralized laboratory analyzers, limiting timely testing in primary care and resource\u2010limited settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We developed and validated a quantitative smartphone\u2010based lateral flow immunoassay (SP\u2010LFIA) comprising a colorimetric strip, a Redmi Note 12R smartphone, a fixed\u2010geometry macro\u2010lens module with integrated LED illumination, and an Android application. The application directly converted background\u2010corrected test\/control\u2010line (T\/C) ratios into concentrations using a batch\u2010specific third\u2010order polynomial calibration model. Analytical validation followed relevant Clinical and Laboratory Standards Institute guidelines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The assay showed a quantitative range of 0.32\u20138.00\u2009mg\/L and a limit of detection of 0.15\u2009mg\/L. Intra\u2010 and inter\u2010assay coefficients of variation were below 10%. No significant interference was observed from bilirubin, triglycerides, hemoglobin, rheumatoid factor, gentamicin sulfate, norvancomycin hydrochloride, or cisplatin at the tested concentrations. Accelerated testing supported strip performance after storage at 50\u00b0C for 28\u2009days. In 120 clinical serum samples, SP\u2010LFIA agreed closely with the commercial particle\u2010enhanced turbidimetric immunoassay reference method (R\n                      <jats:sup>2<\/jats:sup>\n                      \u2009=\u20090.9946), with a mean bias of \u22120.01\u2009mg\/L.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The smartphone\u2010based LFIA provides a reliable, rapid, low\u2010cost, and practical approach to quantitative Cystatin\u2010C testing in point\u2010of\u2010care settings where serum preparation is available.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcla.70372","type":"journal-article","created":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:15:56Z","timestamp":1791274556000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and Analytical Validation of a Smartphone\u2010Based Quantitative Lateral Flow Immunoassay for Serum Cystatin\u2010C"],"prefix":"10.1002","author":[{"given":"Ye","family":"Lian","sequence":"first","affiliation":[{"name":"College of Science, Mathematics and Technology Wenzhou\u2010Kean University  Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruiying","family":"Zheng","sequence":"additional","affiliation":[{"name":"First School of Medicine (School of Information and Engineering) Wenzhou Medical University  Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chenqi","family":"Yang","sequence":"additional","affiliation":[{"name":"College of Information Science and Engineering Ningbo University  Ningbo China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yueyang","family":"Luo","sequence":"additional","affiliation":[{"name":"College of Science, Mathematics and Technology Wenzhou\u2010Kean University  Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Zhang","sequence":"additional","affiliation":[{"name":"School of Laboratory Medicine (School of Life Sciences) Wenzhou Medical University  Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3912-3107","authenticated-orcid":false,"given":"Guojun","family":"Lian","sequence":"additional","affiliation":[{"name":"School of Laboratory Medicine (School of Life Sciences) Wenzhou Medical University  Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baoqing","family":"Li","sequence":"additional","affiliation":[{"name":"Clinical Laboratory Center Second Affiliated Hospital of Wenzhou Medical University  Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,6]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"crossref","first-page":"932","DOI":"10.1056\/NEJMoa1214234","article-title":"Cystatin C Versus Creatinine in Determining Risk Based on Kidney Function","volume":"369","author":"Shlipak M. 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