BACKGROUND: Concentrations of inflammatory and hemostatic variables are influenced by biological variation, which is the natural within-subject variation over time. OBJECTIVES: The aim of this study was to determine fibrinogen, C-reactive protein (CRP), platelet aggregation, thrombin generation and prothrombin time (PT): (i) the number of repeated measurements needed to obtain the true habitual concentration of an individual; (ii) the recommended analytical imprecision for diagnosis and monitoring; (iii) the recommended analytical bias; (iv) the contribution of analytical imprecision to test result variability; (v) the index of individuality; (vi) the reference change value; and (vii) the seasonal variation. SUBJECTS AND METHODS: We collected 520 blood samples over a 1-year period from 40 healthy individuals, and determined the between-subject, within-subject and seasonal variation in fibrinogen, CRP, platelet aggregation, thrombin generation and PT. RESULTS: One or two repeated measurements were sufficient to establish the true habitual concentration, except for platelet aggregation and peak thrombin generation, where at least four and nine repeated measurements were needed, respectively. For diagnosis, the maximal recommended coefficient of analytical variation (CV) was 4%-27%, except for CRP (77.7%). For monitoring, these CVs were on average 3% lower. Recommended analytical bias varied between 1.7% and 33.2%. Finally, seasonal variation was observed in concentrations of fibrinogen and thrombin generation, which could explain approximately 11% of their total variation. CONCLUSION: This study provides insights into the biological variability of selected inflammatory and hemostatic markers, which can be used for sample size calculations and to determine the analytical quality specifications for their respective assays.
BACKGROUND: Concentrations of inflammatory and hemostatic variables are influenced by biological variation, which is the natural within-subject variation over time. OBJECTIVES: The aim of this study was to determine fibrinogen, C-reactive protein (CRP), platelet aggregation, thrombin generation and prothrombin time (PT): (i) the number of repeated measurements needed to obtain the true habitual concentration of an individual; (ii) the recommended analytical imprecision for diagnosis and monitoring; (iii) the recommended analytical bias; (iv) the contribution of analytical imprecision to test result variability; (v) the index of individuality; (vi) the reference change value; and (vii) the seasonal variation. SUBJECTS AND METHODS: We collected 520 blood samples over a 1-year period from 40 healthy individuals, and determined the between-subject, within-subject and seasonal variation in fibrinogen, CRP, platelet aggregation, thrombin generation and PT. RESULTS: One or two repeated measurements were sufficient to establish the true habitual concentration, except for platelet aggregation and peak thrombin generation, where at least four and nine repeated measurements were needed, respectively. For diagnosis, the maximal recommended coefficient of analytical variation (CV) was 4%-27%, except for CRP (77.7%). For monitoring, these CVs were on average 3% lower. Recommended analytical bias varied between 1.7% and 33.2%. Finally, seasonal variation was observed in concentrations of fibrinogen and thrombin generation, which could explain approximately 11% of their total variation. CONCLUSION: This study provides insights into the biological variability of selected inflammatory and hemostatic markers, which can be used for sample size calculations and to determine the analytical quality specifications for their respective assays.
Authors: Niels Lech Pedersen; Mathias Mertz Petersen; Jon J Ladd; Paul D Lampe; Robert S Bresalier; Gerard J Davis; Christina Demuth; Sarah Ø Jensen; Claus L Andersen; Linnea Ferm; Ib J Christensen; Hans J Nielsen Journal: Clin Chim Acta Date: 2020-04-06 Impact factor: 3.786
Authors: Friday Ocheja Zakari; Joseph Olusegun Ayo; Peter Ibrahim Rekwot; Mohammed Umar Kawu Journal: Int J Biometeorol Date: 2015-04-10 Impact factor: 3.787
Authors: Siddhee A Sahasrabudhe; Marcia R Terluk; Kyle D Rudser; James C Cloyd; Reena V Kartha Journal: Int J Mol Sci Date: 2022-08-16 Impact factor: 6.208
Authors: Dana Huskens; Yaqiu Sang; Joke Konings; Lisa van der Vorm; Bas de Laat; Hilde Kelchtermans; Mark Roest Journal: PLoS One Date: 2018-02-01 Impact factor: 3.240