Systematic review and meta-analysis of within-subject and between-subject biological variation data of coagulation and fibrinolytic measurands

Martine J. Hollestelle*, Ann Helen Kristoffersen, René N. Idema, Piet Meijer, Sverre Sandberg, Moniek P.M. De Maat, Aasne K. Aarsand

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Scopus)
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Abstract

Objectives: The diagnosis and monitoring of bleeding and thrombotic disorders depend on correct haemostatic measurements. The availability of high-quality biological variation (BV) data is important in this context. Many studies have reported BV data for these measurands, but results are varied. The present study aims to deliver global within-subject (CVI) and between-subject (CVG) BV estimates for haemostasis measurands by meta-analyses of eligible studies, by assessment with the Biological Variation Data Critical Appraisal Checklist (BIVAC). Methods: Relevant BV studies were graded by the BIVAC. Weighted estimates for CVI and CVG were obtained via meta-analysis of the BV data derived from BIVAC-compliant studies (graded A-C; whereby A represents optimal study design) performed in healthy adults. Results: In 26 studies BV data were reported for 35 haemostasis measurands. For 9 measurands, only one eligible publication was identified and meta-analysis could not be performed. 74% of the publications were graded as BIVAC C. The CVI and CVG varied extensively between the haemostasis measurands. The highest estimates were observed for PAI-1 antigen (CVI 48.6%; CVG 59.8%) and activity (CVI 34.9%; CVG 90.2%), while the lowest were observed for activated protein C resistance ratio (CVI 1.5%; CVG 4.5%). Conclusions: This study provides updated BV estimates of CVI and CVG with 95% confidence intervals for a wide range of haemostasis measurands. These estimates can be used to form the basis for analytical performance specifications for haemostasis tests used in the diagnostic work-up required in bleeding- and thrombosis events and for risk assessment.

Original languageEnglish
Pages (from-to)1470-1480
Number of pages11
JournalClinical Chemistry and Laboratory Medicine
Volume61
Issue number8
Early online date22 Feb 2023
DOIs
Publication statusPublished - 1 Jul 2023

Bibliographical note

Funding Information:
Research funding: Thanks to the Western Norway Regional Health Authority for supporting Ann Helen Kristoffersen with postdoctoral fellowship.

Publisher Copyright:
© 2023 the author(s), published by De Gruyter, Berlin/Boston.

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