Abstract Number: PB0537
Meeting: ISTH 2022 Congress
Theme: Coagulation and Natural Anticoagulants » Coagulation Factors and Inhibitors
Background: Biological variation data obtained in a correct and standardized way is valuable to evaluate the analytical requirements and to assess the utility of a reference interval. No data were found in the literature on short-term biological variation of thrombophilia and hemophilia parameters.
Aims: Our study aimed to determine analytical performance specifications for thrombophilia and hemophilia parameters. The studied parameters were protein C, protein S, activated protein C resistance (APCR), coagulation factors V, VIII, IX, XI and XII. Our second objective was to evaluate if our assays fulfill these criteria. Finally, we aimed to provide a robust tool for comparison of serial measurements of factor V, VIII, IX and XI.
Methods: A blood draw was performed weekly in 19 healthy Caucasian adults for 5 weeks. Hemophilia and thrombophilia parameters were measured in duplicate with Werfen reagents and analyzer. Biological variation components were calculated with nested analysis of variance after exclusion of outliers.
This study was carried out at the clinical hemostasis laboratory of Saint- Luc University Hospital, Brussels, Belgium. Informed consent was obtained from each participant, and the study protocol was approved by the local Ethics Committee.
Results: The analytical coefficient of variation (CV) varied from 1,5% to 4,6%, the within-subject CV from 1,6% to 8,9% and the between-subject CV from 3,8% to 24,0%. All parameters showed a high individuality. For all parameters except APCR, the desirable analytical goal was met with our assays. A reference change value (RCV) of 21.8%, 28%, 20% and 17% was obtained for factor V, VIII, IX and XI respectively.
Conclusion(s): For most parameters, the analytical goals were met. A RCV was obtained for factors V, VIII, IX and XI, facilitating the comparison with previously obtained values in the follow-up of patients with for example hepatic failure or mild hemophilia.
To cite this abstract in AMA style:
Brochier A, Mairesse A, Saussoy P, Gruson D, van Dievoet M. Short-term biological variation study of hemophilia and thrombophilia parameters in a population of Caucasian adults [abstract]. https://abstracts.isth.org/abstract/short-term-biological-variation-study-of-hemophilia-and-thrombophilia-parameters-in-a-population-of-caucasian-adults/. Accessed March 21, 2024.« Back to ISTH 2022 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/short-term-biological-variation-study-of-hemophilia-and-thrombophilia-parameters-in-a-population-of-caucasian-adults/