{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T08:39:59Z","timestamp":1793867999745,"version":"4.6.1"},"reference-count":24,"publisher":"Walter de Gruyter GmbH","issue":"11","license":[{"start":{"date-parts":[[2022,8,29]],"date-time":"2022-08-29T00:00:00Z","timestamp":1661731200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,10,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2022-0749_abs_001\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To assess interlaboratory variability of total serum bilirubin (TSB) results in newborns. Initiated following a clinical incident in which a neonate was transferred to a tertiary hospital for treatment of severe hyperbilirubinemia but on arrival was reclassified into a\u00a0lower risk category due to a 20% difference in TSB between laboratories.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0749_abs_002\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Fresh residual plasma samples from hospital-born infants were pooled to obtain 11 samples across a range of total bilirubin concentrations. Aliquots were light-protected and measured on 7 commercial platforms at 4\u00a0accredited medical laboratories. Data from The Royal College of Pathologists of Australasia Quality Assurance Programs\u2019 (RCPAQAP) Neonatal Bilirubin program was analysed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0749_abs_003\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Twenty-four to 30% difference in results for individual samples, largely due to calibration differences between assays. When interpreted according to guidelines,\u00a0results from different platforms would have led\u00a0to different clinical interventions in some cases. RCPAQAP results showed significant within-method bias but were not shown to be commutable with patient samples<jats:italic>.<\/jats:italic>\n                  <\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2022-0749_abs_004\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>There are clinically significant method-dependent differences in TSB results from neonatal samples, consistent with our clinical incident. The differences are largely due to lack of standardisation of calibrator values. This\u00a0has implications for healthcare resource use and possibly\u00a0for the neurodevelopment of infants. Intervention is\u00a0needed at\u00a0a number of levels, including clinical reporting of\u00a0incidents arising from discordant results, commitment by manufacturers to ensure metrological traceability of methods with sufficiently low uncertainty in the final measurements, and\u00a0availability of commutable quality assurance material to monitor assay performance, especially at the clinical decision points for neonatal jaundice.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2022-0749","type":"journal-article","created":{"date-parts":[[2022,8,29]],"date-time":"2022-08-29T12:47:35Z","timestamp":1661777255000},"page":"1736-1744","source":"Crossref","is-referenced-by-count":18,"title":["Total bilirubin assay differences may cause inconsistent treatment decisions in neonatal hyperbilirubinaemia"],"prefix":"10.1515","volume":"60","author":[{"given":"David H.","family":"Thomas","sequence":"first","affiliation":[{"name":"Clinical Chemistry Liverpool Hospital, NSW Health Pathology , NSW Health Pathology, Liverpool , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet V.","family":"Warner","sequence":"additional","affiliation":[{"name":"Faculty of Medicine , The University of QLD , Saint Lucia , QLD , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham R.D.","family":"Jones","sequence":"additional","affiliation":[{"name":"SydPath, St Vincent\u2019s Hospital, Sydney , Darlinghurst , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7385-0474","authenticated-orcid":false,"given":"Jason Z.Y.","family":"Chung","sequence":"additional","affiliation":[{"name":"Department of Biochemistry , Children\u2019s Hospital at Westmead , Westmead , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Macey","sequence":"additional","affiliation":[{"name":"Central Automated Laboratory and Biochemistry, Douglass Hanly Moir Pathology , Macquarie Park , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Screnci","sequence":"additional","affiliation":[{"name":"Department of Chemical Pathology , St Vincent\u2019s Pathology , Darlinghurst , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua B.","family":"Ryan","sequence":"additional","affiliation":[{"name":"Department of Chemical Pathology , Institute of Clinical Pathology and Medical Research, Westmead Hospital , Westmead , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2022,8,29]]},"reference":[{"key":"2023033113340224576_j_cclm-2022-0749_ref_001","doi-asserted-by":"crossref","unstructured":"Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004;114:297\u2013316. https:\/\/doi.org\/10.1542\/peds.114.1.297.","DOI":"10.1542\/peds.114.1.297"},{"key":"2023033113340224576_j_cclm-2022-0749_ref_002","doi-asserted-by":"crossref","unstructured":"Maisels, MJ. Managing the jaundiced newborn: a persistent challenge. CMAJ (Can Med Assoc J) 2015;187:335\u201343. https:\/\/doi.org\/10.1503\/cmaj.122117.","DOI":"10.1503\/cmaj.122117"},{"key":"2023033113340224576_j_cclm-2022-0749_ref_003","doi-asserted-by":"crossref","unstructured":"Le Pichon, JB, Riordan, SM, Watchko, J, Shapiro, SM. The neurological sequelae of neonatal hyperbilirubinemia: definitions, diagnosis and treatment of the kernicterus spectrum disorders (KSDs). 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The clinical syndrome of bilirubin-induced neurologic dysfunction. Semin Fetal Neonatal Med 2015;20:6\u201313. https:\/\/doi.org\/10.1016\/j.siny.2014.12.008.","DOI":"10.1016\/j.siny.2014.12.008"},{"key":"2023033113340224576_j_cclm-2022-0749_ref_009","unstructured":"Available from: https:\/\/www1.health.nsw.gov.au\/pds\/ActivePDSDocuments\/GL2016_027.pdf [Accessed 1 Aug 2022]."},{"key":"2023033113340224576_j_cclm-2022-0749_ref_010","unstructured":"Available from: https:\/\/www.health.qld.gov.au\/__data\/assets\/pdf_file\/0018\/142038\/g-jaundice.pdf [Accessed 1 Aug 2022]."},{"key":"2023033113340224576_j_cclm-2022-0749_ref_011","doi-asserted-by":"crossref","unstructured":"Bhutani, VK, Johnson, L, Sivieri, EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. 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Bovine serum\u2013based bilirubin calibrators are inappropriate for some diazo methods. Clin Chem 2010;56:869\u201372. https:\/\/doi.org\/10.1373\/clinchem.2009.138925.","DOI":"10.1373\/clinchem.2009.138925"},{"key":"2023033113340224576_j_cclm-2022-0749_ref_022","unstructured":"Available from: https:\/\/www.harmonization.net\/measurands\/ [Accessed 1 Aug 2022]."},{"key":"2023033113340224576_j_cclm-2022-0749_ref_023","doi-asserted-by":"crossref","unstructured":"Doumas, BT, Wu, TW, Poon, KC, Jendrzejczak, B. Chemical nature of a synthetic bilirubin conjugate and its reactivities in the total and direct reactions by the Jendrassik-Gr\u00f3f method. Clin Chem 1985;31:1677\u201382. https:\/\/doi.org\/10.1093\/clinchem\/31.10.1677.","DOI":"10.1093\/clinchem\/31.10.1677"},{"key":"2023033113340224576_j_cclm-2022-0749_ref_024","doi-asserted-by":"crossref","unstructured":"Reif, S, Belson, A, Villa, Y, Milbauer, B, Bujanover, Y. Diurnal variation in serum bilirubin concentrations in infants. 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