Chinese expert consensus on the standardization of antithrombin activity testing (2026 Edition)

  • Clinical Hematology and Body Fluid Group Chinese Society of Laboratory Medicine ,
  • Hemophilia Treatment Center Collaborative Network of China ,
  • Hematology and Body Fluid Analysis Division Shanghai Medical Association Branch of Laboratory Medicine ,
  • Laboratory Diagnosis and Socialized Services Branch of Chinese Health Culture Association
Expand

Received date: 2026-04-16

  Revised date: 2026-05-11

  Accepted date: 2026-07-07

  Online published: 2026-08-31

Abstract

Antithrombin (AT) activity testing is widely used for the diagnosis of hereditary or acquired AT deficiency and for therapeutic monitoring in various diseases. However, laboratories in China face various challenges in testing procedures, quality control, and appropriateness evaluation. This consensus integrates relevant Chinese and international literature on AT activity testing and current practices in China to summarize key issues and propose consensus recommendations, with the aim of standardizing AT activity testing, improving laboratory testing quality, and laying the foundation for establishing standards for related individualized therapies.

Cite this article

Clinical Hematology and Body Fluid Group Chinese Society of Laboratory Medicine , Hemophilia Treatment Center Collaborative Network of China , Hematology and Body Fluid Analysis Division Shanghai Medical Association Branch of Laboratory Medicine , Laboratory Diagnosis and Socialized Services Branch of Chinese Health Culture Association . Chinese expert consensus on the standardization of antithrombin activity testing (2026 Edition)[J]. Journal of Diagnostics Concepts & Practice, 2026 , 25(04) : 433 -441 . DOI: 10.16150/j.1671-2870.2026.04.006

References

[1] Rodgers G M, Mahajerin A. Antithrombin therapy: Current state and future outlook[J]. Clin Appl Thromb Hemost, 2023, 29:10760296231205279.
[2] Van Cott E M, Orlando C, Moore G W, et al. Recommendations for clinical laboratory testing for antithrombin deficiency; Communication from the SSC of the ISTH[J]. J Thromb Haemost, 2020, 18(1):17-22.
[3] 刘秀丽, 周文宾, 李臣宾, 等. 抗凝蛋白检测现状全国性调查与分析[J]. 中华医学杂志, 2017, 97(22):1699-1704.
  Liu Xiuli, Zhou Wenbin, Li Chenbin, et al. Study and analysis of national current status and problems of anticoa-gulant proteins assay[J]. Natl Med J China, 2017, 97(22):1699-1704.
[4] Liu Y, Song Y, Wang Y H, et al. Toward standardized antithrombin activity assays: Multi-center evaluation and optimization[J]. Lab Med Discov, 2026, 3(1):100117.
[5] 李蕾, 吴希, 戴菁, 等. 中国118例颅内静脉窦血栓患者的临床特点及危险因素分析[J]. 诊断学理论与实践, 2023, 22(3):261-269.
  Li Lei, Wu Xi, Dai Jing, et al. Clinical characteristics and risk factor analysis of 118 patients with cerebral venous sinus thrombosis[J]. J Diagn Concepts Pract, 2023, 22(3):261-269.
[6] 沈连军, 吴蔚, 吉薇, 等. 急性粒-单核细胞白血病患者造血干细胞移植后微血栓形成凝血指标监测及治疗1例报告[J]. 诊断学理论与实践, 2024, 23(2):180-183.
  Shen Lianjun, Wu Wei, Ji Wei, et al. A report on monito-ring of coagulation indicators and treatment of microthrombus formation in AML(M4 type)after hematopoietic stem cell transplantation:a case report[J]. J Diagn Concepts Pract, 2024, 23(2):180-183.
[7] Shetty S, Vora S, Kulkarni B, et al. Contribution of natural anticoagulant and fibrinolytic factors in modulating the clinical severity of haemophilia patients[J]. Br J Haematol, 2007, 138(4):541-544.
[8] Ghosh K, Shetty S, Mohanty D. Milder clinical presentation of haemophilia A with severe deficiency of factor Ⅷ as measured by one-stage assay[J]. Haemophilia, 2001, 7(1):9-12.
[9] Halimeh S, Ettingshausen C E, Kurnik K, et al. Sympto-matic onset of severe hemophilia a in childhood is dependent on the presence of prothrombotic risk factors[C]. 31st Hemophilia Symposium Hamburg 2000. Berlin, Heidelberg: Springer,2002:77-80.
[10] Bolliger D, Szlam F, Suzuki N, et al. Heterozygous antithrombin deficiency improves in vivo haemostasis in factor Ⅷ-deficient mice[J]. Thromb Haemost, 2010, 103(6):1233-1238.
[11] 朱礼君, 郑昌成. 世界血友病同盟《全球血友病年度报告2022》解读[J]. 诊断学理论与实践, 2024, 23(1):40-45.
  Zhu Lijun, Zheng Changcheng. Interpretation of the"2022 World Hemophilia Annual Report"by the World Federation of Hemophilia[J]. J Diagn Concepts Pract, 2024, 23(1):40-45.
[12] Pasi K J, Lissitchkov T, Mamonov V, et al. Targeting of antithrombin in hemophilia A or B with investigational siRNA therapeutic fitusiran: Results of the phase 1 inhibitor cohort[J]. J Thromb Haemost, 2021, 19(6):1436-1446.
[13] Young G, Srivastava A, Kavakli K, et al. Efficacy and safety of fitusiran prophylaxis in people with haemophilia A or haemophilia B with inhibitors (ATLAS-INH): A multicentre, open-label, randomised phase 3 trial[J]. Lancet, 2023, 401(10386):1427-1437.
[14] Srivastava A, Rangarajan S, Kavakli K, et al. Fitusiran prophylaxis in people with severe haemophilia A or haemophilia B without inhibitors (ATLAS-A/B): A multicentre, open-label, randomised, phase 3 trial[J]. Lancet Haematol, 2023, 10(5):e322-e332.
[15] Kenet G, Nolan B, Zulfikar B, et al. Fitusiran prophylaxis in people with hemophilia A or B who switched from prior BPA/CFC prophylaxis: The ATLAS-PPX trial[J]. Blood, 2024, 143(22):2256-2269.
[16] Young G, Lenting P J, Croteau S E, et al. Antithrombin-lowering in hemophilia: A closer look at fitusiran[J]. Res Pract Thromb Haemost, 2023, 7(4):100179.
[17] Zhou X, Chen X, Du H, et al. Antithrombin III activity is associated with prognosis, infection, and inflammation in patients with hepatitis B virus-related acute-on-chronic liver failure[J]. Eur J Gastroenterol Hepatol, 2023, 35(8):914-920.
[18] Kim K S, Moon Y J, Kim S H, et al. Low preoperative antithrombin III level is associated with postoperative acute kidney injury after liver transplantation[J]. J Pers Med, 2021, 11(8):716.
[19] Young G A, Perry D J. Laboratory assay measurement of modified clotting factor concentrates: A review of the lite-rature and recommendations for practice[J]. J Thromb Haemost, 2019, 17(4):567-573.
[20] Chhabra E S, Sadeghi-Khomami A, Liu M, et al. Global comparative antithrombin field study: Impact of laboratory assay variability on the assessment of antithrombin activity measurement at fitusiran clinical decision-making points[J]. Haemophilia, 2025, 31(3):566-574.
[21] Rojnik T, Sedlar N, Turk N, et al. Comparison of antithrombin activity assays in detection of patients with heparin binding site antithrombin deficiency: Systematic review and meta-analysis[J]. Sci Rep, 2023, 13:16734.
[22] Seth-Chhabra E, Sadeghi-Khomami A, Mingjie-Liu, et al. Global comparative antithrombin-field study: Impact of laboratory assay variability on the assessment of antithrombin activity measurement[J]. Hematol Transfus Cell Ther, 2024, 46:S155.
[23] 中华人民共和国国家卫生健康委员会. WS/T 359-2024血栓与止血检验常用项目的标本采集与处理[S]. 北京: 中国标准出版社, 2024.
  National Health Commission of the people's Republic of China. National Health Commission of the people's Republic of China. Specimen collection and treatment of common items in thrombus and hemostasis test (WS/T 359-2024)[S]. Beijing: Standards Press of China, 2024.
[24] Clinical Laboratory Standards Institute (CLSI). Collection, transport, and processing of blood specimens for tes-ting plasma-based coagulation assays; approved guideline- 6th Edition (H21)[S]. Wayne,PA: Clinical and Laboratory Standards Institute, 2024.
[25] Gardiner C, Coleman R, de Maat M P M, et al. International Council for Standardization in Haematology (ICSH) laboratory guidance for the evaluation of haemostasis analyser-reagent test systems. Part 1: Instrument-specific issues and commonly used coagulation screening tests[J]. Int J Lab Hematology, 2021, 43(2):169-183.
[26] 中华人民共和国国家卫生健康委员会. WS/T 806-2022临床血液与体液检验基本技术标准[S]. 北京: 中国标准出版社, 2022.
  National Health Commission of the people's Republic of China. Basic technical standards for clinical blood and body fluid testing (WS/T 806-2022)[S]. Beijing: Standards Press of China, 2022.
[27] Kim Y A, Lewandrowski K B, Lucien F A, et al. The effects of transport temperature and time on routine and specialized coagulation assays[J]. Blood Coagulation Fibrinolysis, 2018, 29(2):184-188.
[28] van Balveren J A, Huijskens M J, Gemen E F, et al. Effects of time and temperature on 48 routine chemistry, haematology and coagulation analytes in whole blood samples[J]. Ann Clin Biochem, 2017, 54(4):448-462.
[29] Zürcher M, Sulzer I, Barizzi G, et al. Stability of coagulation assays performed in plasma from citrated whole blood transported at ambient temperature[J]. Thromb Haemost, 2008, 99(2):416-426.
[30] Kemkes-Matthes B, Fischer R, Peetz D. Influence of 8 and 24-h storage of whole blood at ambient temperature on prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time, antithrombin and D-dimer[J]. Blood Coagulation Fibrinolysis, 2011, 22(3):215-220.
[31] Rimac V, Herak D C. Is it acceptable to use coagulation plasma samples stored at room temperature and 4℃ for 24 hours for additional prothrombin time, activated partial thromboplastin time, fibrinogen, antithrombin, and D-dimer testing?[J]. Int J Lab Hematology, 2017, 39(5):475-481.
[32] Heil W, Grunewald R, Amend M, et al. Influence of time and temperature on coagulation analytes in stored plasma[J]. cclm, 1998, 36(7):459-462.
[33] Baker P, Platton S, Gibson C, et al. Guidelines on the laboratory aspects of assays used in haemostasis and thrombosis[J]. Br J Haematol, 2020, 191(3):347-362.
[34] Kitchen S, Adcock D M, Dauer R, et al. International Council for Standardization in Haematology (ICSH) reco-mmendations for processing of blood samples for coagu-lation testing[J]. Int J Lab Hematology, 2021, 43(6):1272-1283.
[35] 戴菁, 马小莉, 刘禹, 等. 血友病非因子治疗的实验室检测:从传统到创新的进展与挑战[J]. 中华检验医学杂志, 2025, 48(8):953-961.
  Dai Jing, Ma Xiaoli, Liu Yu, et al. Laboratory testing for non-factor therapy in hemophilia: progress and challenges from traditional to innovative approaches[J]. Chin J Lab Med, 2025, 48(8):953-961.
[36] Gosselin R C, Castellone D, Dorgalaleh A, et al. International council for standardization in haematology guidance for new lot verification of coagulation reagents, calibrators, and controls[J]. Semin Thromb Hemost, 2024, 50(8):1091-1102.
[37] Gardiner C, Dorgalaleh A, Echenagucia M, et al. International council for standardization in haematology (ICSH) guidance on the validation of laboratory developed tests in haemostasis[J]. Int J Lab Hematology, 2025, 47(4):600-612.
[38] Gardiner C, Coleman R, de Maat M P M, et al. International Council for Standardization in Haematology (ICSH) laboratory guidance for the verification of haemostasis analyser-reagent test systems. Part 2: Specialist tests and calibrated assays[J]. Int J Lab Hematology, 2021, 43(5):907-916.
[39] 国家药品监督管理局. YY 1741-2021抗凝血酶Ⅲ测定试剂盒行业标准[S]. 北京: 中国标准出版社, 2021.
  National Medical Products Administration. Industry standard for antithrombin Ⅲ assay kit (YY 1741-2021)[S]. Beijing: Standards Press of China, 2021.
[40] 中华人民共和国国家卫生健康委员会. WS/T 406-2024临床血液检验常用项目分析质量标准[S]. 北京: 中国标准出版社, 2024.
  National Health Commission of the people's Republic of China. Analysis quality standard of common items in clinical blood test (WS/T 406-2024)[S]. Beijing: Standards Press of China, 2024.
[41] 中华人民共和国国家卫生和计划生育委员会. WS/T 477-2015D-二聚体定量检测[S]. 北京: 中国标准出版社, 2015.
  National Health Commission of the people's Republic of China. Quantitative detection of D-dimer (WS/T 477-2015)[S]. Beijing: Standards Press of China, 2015.
[42] 中华人民共和国国家卫生健康委员会. WS/T 220-2021凝血因子活性测定技术标准[S]. 北京: 中国标准出版社, 2021.
  National Health Commission of the people's Republic of China. Technical standard for determination of coagulation factor activity (WS/T 220-2021)[S]. Beijing: Standards Press of China, 2021.
[43] 中华人民共和国国家卫生健康委员会. WS/T 408-2024定量检验程序分析性能验证指南[S]. 北京: 中国标准出版社, 2024.
  National Health Commission of the people's Republic of China. Guide for verification of analytical performance of quantitative inspection procedures (WS/T 408-2024)[S]. Beijing: Standards Press of China, 2024.
[44] 中华人民共和国国家卫生健康委员会. WS/T 641-2018临床检验定量测定室内质量控制[S]. 北京: 中国标准出版社, 2018.
  National Health Commission of the people's Republic of China. Indoor quality control of clinical laboratory quantitative determination (WS/T641-2018)[S]. Beijing: Standards Press of China, 2018.
[45] 中华人民共和国国家卫生健康委员会. WS/T 402-2024临床实验室定量检验项目参考区间的制定[S]. 北京: 中国标准出版社, 2024.
  National Health Commission of the people's Republic of China. Establishment of reference interval for quantitative test items in clinical laboratory (WS/T402-2024)[S]. Beijing: Standards Press of China, 2024.
Outlines

/

〈 〉