{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T13:01:39Z","timestamp":1783947699725,"version":"3.55.0"},"reference-count":29,"publisher":"Wiley","issue":"23","license":[{"start":{"date-parts":[[2025,10,6]],"date-time":"2025-10-06T00:00:00Z","timestamp":1759708800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The soluble C5b\u20109 (sC5b\u20109) is a soluble form of the Terminal Complement Complex (TCC) that is released into the circulation with elevated levels, associated with increased morbidity and mortality in patients with complement\u2010mediated inflammatory conditions. With the advent of eculizumab and ravulizumab, proper testing for diagnoses and therapeutic monitoring is warranted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We evaluated both the analytical and clinical performance of the Quidel Microvue sC5b\u20109 Plus enzyme immunoassay. Analytical performance was evaluated with precision, linearity, interference studies, and correlation with a reference laboratory. Reference intervals were established using control donor samples [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200926; median age 18.5\u2009years (range 2\u201359)]. Clinical performance of the assay was assessed using plasma samples of patients who (i) developed transplant\u2010associated thrombotic microangiopathy [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200910; median age 14\u2009years (range 3\u201319)], (ii) had reduced ADAMTS13 activity [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096; median age 16\u2009years (range 9\u201318)], and (iii) developed acquired Von\u2010Willebrand disease [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200910; median age 18.5\u2009years (range 0.5\u201318)].\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The assay showed acceptable intra and inter\u2010precision at both low and high levels. Linearity ranged from 12.6 to 160.66\u2009ng\/mL, while accuracy and method correlation studies with a reference laboratory yielded a correlation coefficient (\n                      <jats:italic>R<\/jats:italic>\n                      ) of 0.96. The reference range in control donors was established at \u2264\u2009268.0\u2009ng\/mL. Clinical performance of the assay in patients' plasma revealed elevated sC5b\u20109 levels suggesting complement activation in these patient cohorts compared with control levels.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The Quidel Microvue sC5b\u20109 plus EIA assay demonstrated acceptable analytical performance and clinical utility for monitoring complement activation in patients. Further studies are needed to correlate sC5b\u20109 levels with existing markers of complement activation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcla.70122","type":"journal-article","created":{"date-parts":[[2025,10,6]],"date-time":"2025-10-06T07:48:58Z","timestamp":1759736938000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Soluble C5b\u20109 (sC5b\u20109) in Pediatrics\u2014A Clinical Assessment"],"prefix":"10.1002","volume":"39","author":[{"given":"Ridwan B.","family":"Ibrahim","sequence":"first","affiliation":[{"name":"Department of Pathology and Immunology Baylor College of Medicine  Houston Texas USA"},{"name":"Department of Pathology Texas Children's Hospital  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9483-0886","authenticated-orcid":false,"given":"Radwa","family":"Almamoun","sequence":"additional","affiliation":[{"name":"Department of Pathology and Immunology Baylor College of Medicine  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah E.","family":"Sartain","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Section of Hematology Baylor College of Medicine  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9189-7914","authenticated-orcid":false,"given":"Sridevi","family":"Devaraj","sequence":"additional","affiliation":[{"name":"Department of Pathology and Immunology Baylor College of Medicine  Houston Texas USA"},{"name":"Department of Pathology Texas Children's Hospital  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,6]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.01869"},{"key":"e_1_2_8_3_1","unstructured":"C. A.Janeway P.Travers M.Walport andM. J.Shlomchik \u201cThe Complement System and Innate Immunity \u201d (2001) https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK27100\/."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajpath.2020.02.006"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2021.738927"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.220752"},{"issue":"1","key":"e_1_2_8_7_1","article-title":"Complements and Their Role in Systemic Disorders","volume":"16","author":"Wang S. S. 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