Federation of Dutch Thrombosis Services. Summary annual medical reports 2017. http://www.fnt.nl/. Accessed: 1 Dec 2018.
Jespersen J, Poller L, van den Besselaar AM, van der Meer FJ, Palareti G, Tripodi A, et al. External quality assessment (EQA) for CoaguChek monitors. Thromb Haemost 2010;103:936–41.PubMedWeb of ScienceCrossrefGoogle Scholar
Van den Besselaar AM, Péquériaux NC, Ebben M, van der Feest J, de Jong K, Ganzeboom MB, et al. Point-of-care monitoring of vitamin K-antagonists: validation of CoaguChek XS test strips with international standard thromboplastin. J Clin Pathol 2012;65:1031–5.PubMedCrossrefWeb of ScienceGoogle Scholar
Clinical and Laboratory Standards Institute. Characterization and qualification of commutable reference materials for laboratory medicine; Approved Guideline 2010. CLSI document C53-A.Google Scholar
World Health Organization Expert Committee on Biological Standardization. Guidelines for thromboplastins and plasma used to monitor oral anticoagulant therapy with vitamin K antagonists. WHO Technical Report Series 979;2013:271–316.Google Scholar
Van den Besselaar AM, Witteveen E, van der Meer FJ. Long-term stability of frozen pooled plasmas stored at -70 °C, -40 °C, and -20 °C for prothrombin time and International Normalized Ratio (INR) assessment. Thromb Res 2013;131:349–51.CrossrefWeb of ScienceGoogle Scholar
Poller L, van den Besselaar AM, Jespersen J, Tripodi A, Houghton D. The effect of sample size on fresh plasma thromboplastin ISI determination. Br J Haematol 1999;105:655–63.PubMedCrossrefGoogle Scholar
International Organization for Standardization. Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy. ISO 17593:2007(E).Google Scholar
Ceriotti F, Fernandez-Calle P, Klee GG, Nordin G, Sandberg S, Streichert T, et al. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med 2017;55:189–94.Web of SciencePubMedGoogle Scholar
Kjeldsen J, Lassen JF, Petersen PH, Brandslund I. Biological variation of International Normalized Ratio for prothrombin times, and consequences in monitoring oral anticoagulant therapy: computer simulation of serial measurements with goal-setting for analytical quality. Clin Chem 1997;43: 2175–82.PubMedGoogle Scholar
Poller L, Keown M, Chauhan N, van den Besselaar AM, Tripodi A, Shiach C, et al. European Concerted Action on Anticoagulation. Evaluation of a method for international sensitivity index calibration of two point-of-care prothrombin time (PT) monitoring systems (CoaguChek Mini and TAS PT-NC) with fresh plasmas based on whole-blood equivalent PT. Clin Chem 2002;48:1672–80.PubMedGoogle Scholar
Meijer P, Kluft C, Poller L, van der Meer FJ, Keown M, Ibrahim S, et al. A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors. Am J Clin Pathol 2006;126:756–61.CrossrefPubMedGoogle Scholar
Kitchen DP, Kitchen S, Jennings I, Woods TA, Fitzmaurice DA, Murray ET, et al. Point of care INR testing devices: performance of the Roche CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years’ experience. J Clin Pathol 2012;65:1119–23.CrossrefPubMedWeb of ScienceGoogle Scholar
Bonar R, Mohammed S, Favaloro EJ. International Normalized Ratio monitoring of vitamin K antagonist therapy: comparative performance of point-of-care and laboratory-derived testing. Semin Thromb Hemost 2015;41:279–86.PubMedWeb of ScienceCrossrefGoogle Scholar
Stavelin A, Riksheim BO, Christensen NG, Sandberg S. The importance of reagent lot registration in external quality assurance/proficiency testing schemes. Clin Chem 2016;62:708–15.CrossrefPubMedWeb of ScienceGoogle Scholar
Van den Besselaar AM, Abdoel CF, Ardanary D, van de Kamp G, Versluijs FA. Preparation of control blood for external quality assessment of point-of-care international normalized ratio testing in the Netherlands. Am J Clin Pathol 2014;141:878–83.Web of ScienceCrossrefPubMedGoogle Scholar
Miller WG, Schimmel H, Rej R, Greenberg N, Ceriotti F, Burns C, et al. IFCC Working Group Recommendations for Assessing Commutability Part 1: general experimental design. Clin Chem 2018;64:447–54.CrossrefWeb of ScienceGoogle Scholar
Nilsson G, Budd JR, Greenberg N, Delatour V, Rej R, Panteghini M, et al. IFCC Working Group Recommendations for Assessing Commutability Part 2: using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455–64.CrossrefWeb of ScienceGoogle Scholar
Budd JR, Weykamp C, Rej R, MacKenzie F, Ceriotti F, Greenberg N, et al. IFCC Working Group Recommendations for Assessing Commutability Part 3: using the calibration effectiveness of a reference material. Clin Chem 2018;64:465–74.CrossrefWeb of ScienceGoogle Scholar
About the article
Published Online: 2019-02-14
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved submission.
Research funding: This work was supported in part by Roche Diagnostics Nederland BV and in part by the Federation of Netherlands Thrombosis Services.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.