{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T09:06:16Z","timestamp":1789031176415,"version":"build-2803163510"},"reference-count":23,"publisher":"Walter de Gruyter GmbH","issue":"3","license":[{"start":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T00:00:00Z","timestamp":1778716800000},"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":[[2026,9,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_almed-2026-0028_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Haemolysis is the leading preanalytical cause of sample rejection in coagulation testing. This study prospectively evaluated the impact of spontaneous haemolysis on routine haemostasis assays by comparing paired haemolysed (H)\u00a0and non-haemolysed (NH) clinical samples. Additionally, analyser flagging behaviour was characterised using an artificially haemolysed sample series.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_almed-2026-0028_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Thirty nine paired of H and NH samples were analysed for prothrombin time (PT), activated partial thromboplastin time (aPTT), and D-dimer (DD) on the Sysmex CN-3000. Mean biases were compared against predefined critical differences (CD) derived from biological variation data. Analyser flagging was additionally assessed using five sample pools across five haemolysis concentration levels (H1\u2013H5).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_almed-2026-0028_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>When comparing H samples with NH samples, the mean bias was +0.07\u202fs (+0.14\u202f%) for PT (p=0.5979), +0.44\u202fs (+0.66\u202f%) for aPTT (p=0.8704), and +0.72\u202fmg\/L FEU (+10.63\u202f%) for D-dimer (p=0.0199). D-dimer showed the highest relative bias but remained below the CD (64.7\u202f%). Degree of haemolysis did not predict the magnitude of interference across the range of haemoglobin (Hb) concentrations studied. CN-3000 flagging grades were constant and correlated free Hb and irrespective of baseline sample PT\/aPTT\/D-dimer\u00a0level.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_almed-2026-0028_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Mild to moderate spontaneous haemolysis does not produce clinically significant interference in PT, aPTT, or D-dimer. CN-3000 flagging behaviour is predictable and grade-dependent. Re-evaluation of automatic haemolysis rejection thresholds is warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/almed-2026-0028","type":"journal-article","created":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T11:55:58Z","timestamp":1778673358000},"page":"179-186","source":"Crossref","is-referenced-by-count":0,"title":["Re-evaluating haemolysis rejection criteria for PT, aPTT, and D-dimer testing: evidence from paired clinical samples on the CN-3000 analyser"],"prefix":"10.1515","volume":"7","author":[{"given":"Jirapa","family":"Kaewkhruawan","sequence":"first","affiliation":[{"name":"Division of Laboratory Medicine , King Chulalongkorn Memorial Hospital , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wararat","family":"Masalae","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine , King Chulalongkorn Memorial Hospital , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Surapat","family":"Tanticharoenkarn","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine , King Chulalongkorn Memorial Hospital , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pitchayaporn","family":"Riyagoon","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine , King Chulalongkorn Memorial Hospital , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waroonkarn","family":"Laiklang","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine , King Chulalongkorn Memorial Hospital , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwanlada","family":"Chaiwong","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine , King Chulalongkorn Memorial Hospital , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suppakorn","family":"Wongkamchai","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine , King Chulalongkorn Memorial Hospital , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8270-5308","authenticated-orcid":false,"given":"Phandee","family":"Watanaboonyongcharoen","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7043-8062","authenticated-orcid":false,"given":"Chutitorn","family":"Ketloy","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-1790-9841","authenticated-orcid":false,"given":"Orakan","family":"Limpornpugdee","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7565-9211","authenticated-orcid":false,"given":"Eakachai","family":"Prompetchara","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,5,14]]},"reference":[{"key":"2026091008070974256_j_almed-2026-0028_ref_001","doi-asserted-by":"crossref","unstructured":"Plebani, M, Carraro, P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997;43:1348\u201351. https:\/\/doi.org\/10.1093\/clinchem\/43.8.1348.","DOI":"10.1093\/clinchem\/43.8.1348"},{"key":"2026091008070974256_j_almed-2026-0028_ref_002","doi-asserted-by":"crossref","unstructured":"Lippi, G, Banfi, G, Church, S, Cornes, M, De Carli, G, Grankvist, K, et al.. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE). Clin Chem Lab Med 2015;53:357\u201370. https:\/\/doi.org\/10.1515\/cclm-2014-1051.","DOI":"10.1515\/cclm-2014-1051"},{"key":"2026091008070974256_j_almed-2026-0028_ref_003","doi-asserted-by":"crossref","unstructured":"Lippi, G, Blanckaert, N, Bonini, P, Green, S, Kitchen, S, Palicka, V, et al.. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med 2008;46:764\u201372. https:\/\/doi.org\/10.1515\/cclm.2008.170.","DOI":"10.1515\/CCLM.2008.170"},{"key":"2026091008070974256_j_almed-2026-0028_ref_004","doi-asserted-by":"crossref","unstructured":"Getawa, S, Aynalem, M, Melku, M, Adane, T. Blood specimen rejection rate in clinical laboratory: a systematic review and meta-analysis. Pract Lab Med 2023;33:e00303. https:\/\/doi.org\/10.1016\/j.plabm.2022.e00303.","DOI":"10.1016\/j.plabm.2022.e00303"},{"key":"2026091008070974256_j_almed-2026-0028_ref_005","doi-asserted-by":"crossref","unstructured":"Lippi, G, Plebani, M, Favaloro, EJ. Interference in coagulation testing: focus on spurious hemolysis, icterus, and lipemia. Semin Thromb Hemost 2013;39:258\u201366. https:\/\/doi.org\/10.1055\/s-0032-1328972.","DOI":"10.1055\/s-0032-1328972"},{"key":"2026091008070974256_j_almed-2026-0028_ref_006","doi-asserted-by":"crossref","unstructured":"Hernaningsih, Y, Akualing, JS. The effects of hemolysis on plasma prothrombin time and activated partial thromboplastin time tests using photo-optical method. Medicine (Baltim) 2017;96:e7976. https:\/\/doi.org\/10.1097\/md.0000000000007976.","DOI":"10.1097\/MD.0000000000007976"},{"key":"2026091008070974256_j_almed-2026-0028_ref_007","doi-asserted-by":"crossref","unstructured":"Protty, MB, Jenkins, PV, Collins, PW, O\u2019Donnell, VB. The role of procoagulant phospholipids on the surface of circulating blood cells in thrombosis and haemostasis. Open Biol 2022;12:210318. https:\/\/doi.org\/10.1098\/rsob.210318.","DOI":"10.1098\/rsob.210318"},{"key":"2026091008070974256_j_almed-2026-0028_ref_008","unstructured":"Marques-Garcia, F. Methods for hemolysis interference study in laboratory medicine\u00a0\u2013\u00a0a critical review. EJIFCC 2020;31:85\u201397."},{"key":"2026091008070974256_j_almed-2026-0028_ref_009","doi-asserted-by":"crossref","unstructured":"Green, SF. The cost of poor blood specimen quality and errors in preanalytical processes. Clin Biochem 2013;46:1175\u20139. https:\/\/doi.org\/10.1016\/j.clinbiochem.2013.06.001.","DOI":"10.1016\/j.clinbiochem.2013.06.001"},{"key":"2026091008070974256_j_almed-2026-0028_ref_010","unstructured":"Clinical and Laboratory Standards Institute. Hemolysis, icterus, and lipemia\/turbidity indices as indicators of interference in clinical laboratory analysis; C56-A. Wayne, PA: CLSI; 2012."},{"key":"2026091008070974256_j_almed-2026-0028_ref_011","doi-asserted-by":"crossref","unstructured":"Limpornpugdee, O, Tanticharoenkarn, S, Thepnarin, T, Yeekaday, M, Riyagoon, P, Laiklang, W, et al.. Development and assessment of autoverification system for routine coagulation assays in inpatient and outpatient settings of tertiary care hospital: algorithm performance and impact on laboratory efficiency. Diagnosis (Berl). 2025;12:452\u201363. https:\/\/doi.org\/10.1515\/dx-2025-0004.","DOI":"10.1515\/dx-2025-0004"},{"key":"2026091008070974256_j_almed-2026-0028_ref_012","unstructured":"Clinical and Laboratory Standards Institute. Collection, transport, and processing of blood specimens for testing plasma-based coagulation assays; H21. Wayne, PA: CLSI; 2024."},{"key":"2026091008070974256_j_almed-2026-0028_ref_013","doi-asserted-by":"crossref","unstructured":"Perez-Montero, B, Fermin-Rodriguez, ML, Miro, G, de Juan, L, Cruz-Lopez, F. Hemolysis, icterus and lipemia interfere with the determination of two oxidative stress biomarkers in canine serum. BMC Vet Res 2023;19:172. https:\/\/doi.org\/10.1186\/s12917-023-03740-y.","DOI":"10.1186\/s12917-023-03740-y"},{"key":"2026091008070974256_j_almed-2026-0028_ref_014","doi-asserted-by":"crossref","unstructured":"Ricos, C, Alvarez, V, Cava, F, Garcia-Lario, JV, Hernandez, A, Jimenez, CV, et al.. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59:491\u2013500. https:\/\/doi.org\/10.1080\/00365519950185229.","DOI":"10.1080\/00365519950185229"},{"key":"2026091008070974256_j_almed-2026-0028_ref_015","doi-asserted-by":"crossref","unstructured":"Arora, S, Kolte, S, Dhupia, J. Hemolyzed samples should be processed for coagulation studies: the study of hemolysis effects on coagulation parameters. Ann Med Health Sci Res 2014;4:233\u20137. https:\/\/doi.org\/10.4103\/2141-9248.129049.","DOI":"10.4103\/2141-9248.129049"},{"key":"2026091008070974256_j_almed-2026-0028_ref_016","doi-asserted-by":"crossref","unstructured":"Hedeland, Y, Gustafsson, CM, Touza, Z, Ridefelt, P. Hemolysis interference in 10 coagulation assays on an instrument with viscosity-based, chromogenic, and turbidimetric clot detection. Int J Lab Hematol 2020;42:341\u20139. https:\/\/doi.org\/10.1111\/ijlh.13188.","DOI":"10.1111\/ijlh.13188"},{"key":"2026091008070974256_j_almed-2026-0028_ref_017","doi-asserted-by":"crossref","unstructured":"Nougier, C, Jousselme, E, Sobas, F, Pousseur, V, Negrier, C. Effects of hemolysis, bilirubin, and lipemia interference on coagulation tests detected by two analytical systems. Int J Lab Hematol 2020;42:88\u201394. https:\/\/doi.org\/10.1111\/ijlh.13147.","DOI":"10.1111\/ijlh.13147"},{"key":"2026091008070974256_j_almed-2026-0028_ref_018","doi-asserted-by":"crossref","unstructured":"Novelli, C, Vidali, M, Brando, B, Morelli, B, Andreani, G, Arini, M, et al.. A collaborative study by the Working Group on Hemostasis and Thrombosis of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) on the interference of haemolysis on five routine blood coagulation tests by evaluation of 269 paired haemolysed\/non-haemolysed samples. Biochem Med (Zagreb) 2018;28:030711. https:\/\/doi.org\/10.11613\/bm.2018.030711.","DOI":"10.11613\/BM.2018.030711"},{"key":"2026091008070974256_j_almed-2026-0028_ref_019","doi-asserted-by":"crossref","unstructured":"Orhan, S, Isbilen, E. Comparison of SYSMEX CN-6000 and STAGO STA-R: effects of hemolysis and lipemia. J\u00a0Med Biochem 2025;44:976\u201384. https:\/\/doi.org\/10.5937\/jomb0-56377.","DOI":"10.5937\/jomb0-56377"},{"key":"2026091008070974256_j_almed-2026-0028_ref_020","doi-asserted-by":"crossref","unstructured":"Righini, M, Van Es, J, Den Exter, PL, Roy, PM, Verschuren, F, Ghuysen, A, et al.. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA 2014;311:1117\u201324. https:\/\/doi.org\/10.1001\/jama.2014.2135.","DOI":"10.1001\/jama.2014.2135"},{"key":"2026091008070974256_j_almed-2026-0028_ref_021","doi-asserted-by":"crossref","unstructured":"Alp, HH, Tran, MTC, Markus, C, Ho, CS, Loh, TP, Zakaria, R, et al.. Clinical vs. statistical significance: considerations for clinical laboratories. Clin Chem Lab Med 2025;63:1503\u201318. https:\/\/doi.org\/10.1515\/cclm-2025-0219.","DOI":"10.1515\/cclm-2025-0219"},{"key":"2026091008070974256_j_almed-2026-0028_ref_022","doi-asserted-by":"crossref","unstructured":"AbdulRaheem, Y. Statistical significance versus clinical relevance: key considerations in interpretation medical research data. Indian J Community Med 2024;49:791\u20135. https:\/\/doi.org\/10.4103\/ijcm.ijcm_601_23.","DOI":"10.4103\/ijcm.ijcm_601_23"},{"key":"2026091008070974256_j_almed-2026-0028_ref_023","doi-asserted-by":"crossref","unstructured":"Lippi, G, Cadamuro, J, von Meyer, A, Simundic, AM, European Federation of Clinical C, Laboratory Medicine Working Group for Preanalytical P. Practical recommendations for managing hemolyzed samples in clinical chemistry testing. Clin Chem Lab Med 2018;56:718\u201327. https:\/\/doi.org\/10.1515\/cclm-2017-1104.","DOI":"10.1515\/cclm-2017-1104"}],"container-title":["Advances in Laboratory Medicine \/ Avances en Medicina de Laboratorio"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.degruyterbrill.com\/document\/doi\/10.1515\/almed-2026-0028\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyterbrill.com\/document\/doi\/10.1515\/almed-2026-0028\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T08:08:51Z","timestamp":1789027731000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyterbrill.com\/document\/doi\/10.1515\/almed-2026-0028\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,14]]},"references-count":23,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,7,7]]},"published-print":{"date-parts":[[2026,9,9]]}},"alternative-id":["10.1515\/almed-2026-0028"],"URL":"https:\/\/doi.org\/10.1515\/almed-2026-0028","relation":{},"ISSN":["2628-491X"],"issn-type":[{"value":"2628-491X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,14]]}}}