{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T08:15:31Z","timestamp":1774685731072,"version":"3.50.1"},"reference-count":23,"publisher":"Walter de Gruyter GmbH","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2022-0433_abs_001\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>In adults, the elevation of cardiac troponin (cTn) above the 99th percentile upper reference limit defines myocardial injury. The use and interpretation of cTn in a paediatric population, however, is difficult given the 99th percentile for different assays is not well established. Using paediatric blood samples from healthy neonates, infants and children we derived continuous and partitioned 97.5th and 99th percentiles for the Ortho VITROS hs-TnI assay.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0433_abs_002\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A total of 328 samples for infants, children and adolescents aged 0\u201317.8\u00a0years were obtained. Age partitioned reference limits were derived in accordance with CLSI EP28-A3C. Continuous reference limits were established as described previously by the HAPPI Kids Study team.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0433_abs_003\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>hs-TnI as measured by the Ortho VITROS Assay is highly elevated above the adult 99th percentile at birth and declines to lower levels within the first 6\u00a0months of life. The 99th centile upper reference limit for ages 0\u20133\u00a0months was 72\u00a0ng\/L (90% CI: 52\u201391) and 9\u00a0ng\/L (90% CI: 5.2\u201317.4) for ages 3\u00a0months to 18\u00a0years. Continuous upper 99th centile reference limits were comparable.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0433_abs_004\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Partitioned and continuous 99th percentiles for hs-TnI were derived for the new Ortho VITROS assay in healthy neonates and older children. This will assist clinicians to appropriately assess for the presence of myocardial injury in this population.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2022-0433","type":"journal-article","created":{"date-parts":[[2022,7,4]],"date-time":"2022-07-04T19:22:56Z","timestamp":1656962576000},"page":"1449-1454","source":"Crossref","is-referenced-by-count":3,"title":["Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort"],"prefix":"10.1515","volume":"60","author":[{"given":"Joel","family":"Smith","sequence":"first","affiliation":[{"name":"The Royal Children\u2019s Hospital , Parkville , VIC , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vasiliki","family":"Karlaftis","sequence":"additional","affiliation":[{"name":"Murdoch Children\u2019s Research Institute , Parkville , VIC , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Hearps","sequence":"additional","affiliation":[{"name":"Murdoch Children\u2019s Research Institute , Parkville , VIC , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Chiriano","sequence":"additional","affiliation":[{"name":"The Royal Children\u2019s Hospital , Parkville , VIC , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Monagle","sequence":"additional","affiliation":[{"name":"The Royal Children\u2019s Hospital , Parkville , VIC , Australia"},{"name":"Murdoch Children\u2019s Research Institute , Parkville , VIC , Australia"},{"name":"Department of Paediatrics , The University of Melbourne , Parkville , VIC , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"374","published-online":{"date-parts":[[2022,7,4]]},"reference":[{"key":"2023033112140898392_j_cclm-2022-0433_ref_001","doi-asserted-by":"crossref","unstructured":"Thygesen, K, Alpert, JS, Jaffe, AS, Chaitman, BR, Bax, JJ, Morrow, DA, et al.. 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Assessment of the 99th or 97.5th percentile for cardiac troponin I in a healthy pediatric cohort. Clin Chem 2014;60:1574\u20136. https:\/\/doi.org\/10.1373\/clinchem.2014.228619.","DOI":"10.1373\/clinchem.2014.228619"},{"key":"2023033112140898392_j_cclm-2022-0433_ref_005","doi-asserted-by":"crossref","unstructured":"Karlen, J, Karlsson, M, Eliasson, H, Bonamy, AE, Halvorsen, CP. Cardiac troponin T in healthy full-term infants. Pediatr Cardiol 2019;40:1645\u201354. https:\/\/doi.org\/10.1007\/s00246-019-02199-9.","DOI":"10.1007\/s00246-019-02199-9"},{"key":"2023033112140898392_j_cclm-2022-0433_ref_006","doi-asserted-by":"crossref","unstructured":"Hickman, PE, Badrick, T, Wilson, SR, McGill, D. Reporting of cardiac troponin\u00a0\u2013 problems with the 99th population percentile. 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