Standardization of Prothrombin Time/International Normalized Ratio (PT/INR).
INR
coagulation factors
harmonization
hemostasis
prothrombin time
standardization
Journal
International journal of laboratory hematology
ISSN: 1751-553X
Titre abrégé: Int J Lab Hematol
Pays: England
ID NLM: 101300213
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
01
07
2020
revised:
02
09
2020
accepted:
07
09
2020
pubmed:
27
9
2020
medline:
7
5
2021
entrez:
26
9
2020
Statut:
ppublish
Résumé
The prothrombin time (PT) represents the most commonly used coagulation test in clinical laboratories. The PT is mathematically converted to the international normalized ratio (INR) for use in monitoring anticoagulant therapy with vitamin K antagonists such as warfarin in order to provide test results that are adjusted for thromboplastin and instrument used. The INR is created using two major PT 'correction factors', namely the mean normal PT (MNPT) and the international sensitivity index (ISI). Manufacturers of reagents and coagulometers have made some efforts to harmonizing INRs, for example, by tailoring reagents to specific coagulometers and provide associated ISI values. Thus, two types of ISIs may be generated, with one being a 'general' or 'generic' ISI and others being reagent/coagulometer-specific ISI values. Although these play a crucial role in improving INR results between laboratories, these laboratories reported INR values are known to still differ, even when laboratories use the same thromboplastin reagent and coagulometer. Moreover, ISI values for a specific thromboplastin can vary among different models of coagulometers from a manufacturer using the same method for clot identification. All these factors can be sources of error for INR reporting, which in turn can significantly affect patient management. In this narrative review, we provide some guidance to appropriate ISI verification/validation, which may help decrease the variability in cross laboratory reporting of INRs.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
21-28Subventions
Organisme : Yasuj University of Medical Sciences
Informations de copyright
© 2020 John Wiley & Sons Ltd.
Références
Meijer P, Kynde K, van den Besselaar AM, Van Blerk M, Woods TA. International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents. Clin Chem Lab Med. 2018;56(10):1698-1703.
Dorgalaleh A, Daneshi M, Rashidpanah J, Yasaghi ER. An Overview of Hemostasis. Congenital Bleeding Disorders. Diagnosis and Management. Cham, Switzerland: Springer; 2018:3-26. https://link.springer.com/chapter/10.1007/978-3-319-76723-9_1.
van Ommen CH, Peters M. Clinical practice: the bleeding child. Part I: primary hemostatic disorders. Eur J Pediatr. 2012;171(1):1-10.
Favaloro EJ. Optimizing the Verification of Mean Normal Prothrombin Time (MNPT) and International Sensitivity Index (ISI) for Accurate Conversion of Prothrombin Time (PT) to International Normalized Ratio (INR). Hemostasis and Thrombosis. Methods and Protocols. Cham, Switzerland: Springer; 2017:59-74.
Palta S, Saroa R, Palta A. Overview of the coagulation system. Indian J Anaesth. 2014;58(5):515.
Dorgalaleh A, Rad F. Congenital Bleeding Disorders. Congenital Bleeding Disorders. Diagnosis and Managment. Cham, Switzerland: Springer; 2018;27-53. https://link.springer.com/chapter/10.1007/978-3-319-76723-9_2.
Medcalf RL. What drives “fibrinolysis”? Hämostaseologie. 2015;35(04):303-310.
Kamal AH, Tefferi A, Pruthi RK. How to interpret and pursue an abnormal prothrombin time, activated partial thromboplastin time, and bleeding time in adults. Mayo Clin Proc. 2007;82(7):864-873.
Rad F, Hamidpour M, Dorgalaleh A, et al. The effect of demographic factors and VKORC1 1639 G>A genotypes on estimated warfarin maintenance dose in Iranian patients under warfarin therapy. Indian J Hematol Blood Transfus. 2019;35:167-171.
De Caterina R, Husted S, Wallentin L, et al. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Thromb Haemost. 2013;110(12):1087-1107.
Choufani EB, Sanchorawala V, Ernst T, et al. Acquired factor X deficiency in patients with amyloid light-chain amyloidosis: incidence, bleeding manifestations, and response to high-dose chemotherapy. Blood. 2001;97(6):1885-1887.
Flanders MM, Crist R, Rodgers GM. Comparison of five thrombin time reagents. Clin Chem. 2003;49(1):169-172.
Poller L. International Normalized Ratios (INR): the first 20 years. J Thromb Haemost. 2004;2(6):849-860.
Hull R, Hirsh J, Jay R, et al. Different intensities of oral anticoagulant therapy in the treatment of proximal-vein thrombosis. N Engl J Med. 1982;307(27):1676-1681.
Poller L. The British comparative thromboplastin: the use of the national thromboplastin reagent for uniformity of laboratory control of oral anticoagulants and expression of results. ACP Broadsheet. 1970;71:1-6.
Kirkwood T. Calibration of reference thromboplastins and standardisation of the prothrombin time ratio. Thromb Haemost. 1983;50(03):238-244.
Catlett RH, Welch M. "Deep venous thrombosis: guide to tailoring the prophylactic regimen. Consultant. 1996;36(7):1489-1496.
Lippi G, Favaloro EJ. Laboratory monitoring of direct oral anticoagulants (DOACs)-The perfect storm? Ann Transl Med. 2017;5(1):6.
Mueck W, Stampfuss J, Kubitza D, Becka M. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin Pharmacokinet. 2014;53(1):1-16.
Pollack CV. Introduction to direct oral anticoagulants and rationale for specific reversal agents. Am J Emerg Med. 2016;34(11):1-2.
Vazquez S, Rondina MT. Direct oral anticoagulants (DOACs). Vasc Med. 2015;20(6):575-577.
Poller L. The effect of the use of different tissue extracts on one-stage prothrombin times. Acta Haematol. 1964;32(5):292-298.
Organization WH. WHO Expert Committee on Biological Standardization: Fifty-Fifth Report. Geneva, Switzerland: World Health Organization; 2005.
Tripodi A, Chantarangkul V, Primignani M, et al. The international normalized ratio calibrated for cirrhosis (INR[liver]) normalizes prothrombin time results for model for end-stage liver disease calculation. Hepatology. 2007;46(2):520-527.
Tange JI, Grill D, Koch CD, et al. Local verification and assignment of mean normal prothrombin time and international sensitivity index values across various instruments: recent experience and outcome from North America. Semin Thromb Hemost. 2014;40(01):115-120.
Favaloro EJ. How to generate a more accurate laboratory-based international normalized ratio: solutions to obtaining or verifying the mean normal prothrombin time and international sensitivity index. Semin Thromb Hemost. 2019;45(01):10-21
Standardization WECoB. WHO Expert Committee on Biological Standardization: Forty-first Report. Geneva, Switzerland: World Health Organization; 1991.
Kitchens CS, Konkle BA, Kessler CM. Consultative Hemostasis and Thrombosis E-Book. Edinburgh, London: Elsevier Health Sciences; 2013.
Holbrook A, Schulman S, Witt DM, et al. Evidence-based management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2):e152S-e184.
Eichinger S. Reversing vitamin K antagonists: making the old new again. Hematology. 2016;2016(1):605-611.
Jackson CM, Esnouf MP. Has the Time Arrived to Replace the Quick Prothrombin Time Test for Monitoring Oral Anticoagulant Therapy?. Oxfordshire, England: Oxford University Press; 2005.
Poller L, Ibrahim S, Keown M, Pattison A, Jespersen J. Simplified method for international normalized ratio (INR) derivation based on the prothrombin time/INR line: an international study. Clin Chem. 2010;56(10):1608-1617.
Ozturk M, Ipekci A, Kiyak SK, et al. Bleeding complications in warfarin-treated patients admitted to the emergency department. J Clin Med Res. 2019;11(2):106.
Kuruvilla M, Gurk-Turner C. A review of warfarin dosing and monitoring. Proc (Bayl Univ Med Cent). 2001;14(3):305.
Asarcıklı LD, Şen T, İpek EG, et al. Time in therapeutic range (TTR) value of patients who use warfarin and factors which influence TTR. J Am Coll Cardiol. 2013;62(18 Supplement 2):C127-C128.
Brouwer JLP, Stoevelaar H, Sucker C. The clinical impact of different coagulometers on patient outcomes. Adv Ther. 2014;31(6):639-656.
Kalçık M, Yesin M, Gürsoy MO, et al. Comparison of the INR values measured by CoaguChek XS coagulometer and conventional laboratory methods in patients on VKA therapy. Clin Appl Thromb Hemost. 2017;23(2):187-194.
APA. Laboratory errors suspected as cause of two deaths: warfarin is commonly associated with medication errors, and its appropriate use is an important indicator of patient safety. Emerg Med News. 2002:24(6):58.
Ng VL. Prothrombin time and partial thromboplastin time assay considerations. Clin Lab Med. 2009;29(2):253-263.
Van den Besselaar A, Houbouyan L, Aillaud M, et al. Influence of three types of automated coagulometers on the International Sensitivity Index (ISI) of rabbit, human, and recombinant human tissue factor preparations. Thromb Haemost. 1999;81(01):66-70.
Riley RS, Rowe D, Fisher LM. Clinical utilization of the international normalized ratio (INR). J Clin Lab Anal. 2000;14(3):101-114.
Marlar RA, Gausman JN. Do you report an accurate international normalized ratio? Find out using local verification and calibration. Lab Med. 2011;42(3):176-181.
Budak YU, Huysal K, Polat M, Tarakçi G, Uçar H. Evaluation of the Steelex M600H coagulometer prothrombin time-international normalized ratio assay with Steelex test reagents. Biochem Med. 2012;22(1):121-126.
Horsti J, Uppa H, Vilpo JA. Poor agreement among prothrombin time international normalized ratio methods: comparison of seven commercial reagents. Clin Chem. 2005;51(3):553-560.
Bonar R, Favaloro EJ. Explaining and reducing the variation in inter-laboratory reported values for international normalised ratio. Thromb Res. 2017;150:22-29.
Favaloro EJ, McVicker W, Lay M, et al. Harmonizing the International Normalized Ratio (INR) standardization of methods and use of novel strategies to reduce interlaboratory variation and bias. Am J Clin Pathol. 2016;145(2):191-202.
Expert W. Committee on Biological Standardization. Requirements for Thromboplastins and Plasmas Used to Control Oral Anticoagulant Therapy. Geneva, Switzerland: WHO Technical Report Series; 1983;81-105.
Time COSP. Test and Activate Partial Thromboplastin Time (APTT) Test: Approved Guideline. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
Favaloro EJ, Hamdam S, McDonald J, McVicker W, Ule V. Time to think outside the box? Prothrombin time, international normalised ratio, international sensitivity index, mean normal prothrombin time and measurement of uncertainty a novel approach to standardisation. Pathology. 2008;40(3):277-287.
Adcock DM, Brien WF, Duff S, et al. Procedures for validation of INR and local calibration of PT/INR systems; approved guideline. Clin Lab Standards Institute H54-A. 2005;25(23):1-64.
Van den Besselaar A, Barrowcliffe T, Houbouyan-Reveillard L, et al. Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. J Thromb Haemost. 2004;2(11):1946-1953.
Poller L, Ibrahim S, Keown M, Pattison A, Jespersen J; Anticoagulation EAo. The prothrombin time/international normalized ratio (PT/INR) Line: derivation of local INR with commercial thromboplastins and coagulometers-two independent studies. J Thromb Haemost. 2011;9(1):140-148.
Ibrahim SA, Jespersen J, Pattison A, Poller L. Evaluation of European Concerted Action on Anticoagulation lyophilized plasmas for INR derivation using the PT/INR Line. Am J Clin Pathol. 2011;135(5):732-740.
Houbouyan LL, Goguel AF. Long-term French experience in INR standardization by a procedure using plasma calibrants. Am J Clin Pathol. 1997;108(1):83-89.