BACKGROUND: Levels of hemostasis factors vary between and within individuals as a result of genetic and environmental factors and analytical variation of the assays. The current state of the art for defining analytical precision requirements for analytical testing is based on this between- and within-individual (biological) variation. However, information on biological variation in hemostasis variables is still limited.The aim of this study was to determine the biological variation of coagulation variables involved in thrombosis and bleeding to provide a recommendation for performance specifications and to assess whether hemostasis assays fulfill the recommendation. METHODS: We performed a longitudinal study by repeated blood sampling (in total 13 times over a 1-year period) in 40 healthy individuals and measured prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, antithrombin, factor VIII, factor IX, von Willebrand factor (VWF), protein C, and protein S. We evaluated the effect of the biological variation on parameters of analytical variation and propose required performance specifications. RESULTS: Biological variation was highly different for various hemostasis variables: the within-subject variation ranged from 2.6% (PT) to 25.6% [VWF collagen binding (CB) activity], the between-subject variation varied from 4.1% (PT) to 31.2% (VWF:ristocetin cofactor acitivity), and the assay variation from 1.3% (PT) to 12.9% (VWF:CB). CONCLUSIONS: With the reagents and analyzers used in this study, most of the hemostasis tests variables fulfill the current quality criteria for diagnosis and monitoring of routine hemostasis assays.
BACKGROUND: Levels of hemostasis factors vary between and within individuals as a result of genetic and environmental factors and analytical variation of the assays. The current state of the art for defining analytical precision requirements for analytical testing is based on this between- and within-individual (biological) variation. However, information on biological variation in hemostasis variables is still limited.The aim of this study was to determine the biological variation of coagulation variables involved in thrombosis and bleeding to provide a recommendation for performance specifications and to assess whether hemostasis assays fulfill the recommendation. METHODS: We performed a longitudinal study by repeated blood sampling (in total 13 times over a 1-year period) in 40 healthy individuals and measured prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, antithrombin, factor VIII, factor IX, von Willebrand factor (VWF), protein C, and protein S. We evaluated the effect of the biological variation on parameters of analytical variation and propose required performance specifications. RESULTS: Biological variation was highly different for various hemostasis variables: the within-subject variation ranged from 2.6% (PT) to 25.6% [VWF collagen binding (CB) activity], the between-subject variation varied from 4.1% (PT) to 31.2% (VWF:ristocetin cofactor acitivity), and the assay variation from 1.3% (PT) to 12.9% (VWF:CB). CONCLUSIONS: With the reagents and analyzers used in this study, most of the hemostasis tests variables fulfill the current quality criteria for diagnosis and monitoring of routine hemostasis assays.
Authors: Frank Driessler; Maricel G Miguelino; Glenn F Pierce; Robert T Peters; Jurg M Sommer Journal: Blood Coagul Fibrinolysis Date: 2017-10 Impact factor: 1.276
Authors: Johan Boender; Angelique Nederlof; Karina Meijer; Evelien P Mauser-Bunschoten; Marjon H Cnossen; Karin Fijnvandraat; Johanna G van der Bom; Joke de Meris; Britta A P Laros-van Gorkom; Karin P M van Galen; Jeroen Eikenboom; Moniek P M de Maat; Frank W G Leebeek Journal: Res Pract Thromb Haemost Date: 2020-10-31
Authors: Judith J de Vries; Chantal Visser; Lotte Geers; Johan A Slotman; Nadine D van Kleef; Coen Maas; Hannelore I Bax; Jelle R Miedema; Eric C M van Gorp; Marco Goeijenbier; Johannes P C van den Akker; Henrik Endeman; Dingeman C Rijken; Marieke J H A Kruip; Moniek P M de Maat Journal: J Thromb Haemost Date: 2022-04-01 Impact factor: 16.036
Authors: Ferdows Atiq; Karina Meijer; Jeroen Eikenboom; Karin Fijnvandraat; Eveline P Mauser-Bunschoten; Karin P M van Galen; Marten R Nijziel; Paula F Ypma; Joke de Meris; Britta A P Laros-van Gorkom; Johanna G van der Bom; Moniek P de Maat; Marjon H Cnossen; Frank W G Leebeek Journal: Br J Haematol Date: 2018-05-16 Impact factor: 6.998