Biological variation data for lipid cardiovascular risk assessment biomarkers. A systematic review applying the biological variation data critical appraisal checklist (BIVAC)

Jorge Díaz-Garzón, Pilar Fernández–Calle, Joana Minchinela, Aasne K. Aarsand, William A. Bartlett, Berna Aslan, Beatriz Boned, Federica Braga, Anna Carobene, Abdurrahman Coskun, Elisabet Gonzalez-Lao, Niels Jonker, Fernando Marques-Garcia, Carmen Perich, Carmen Ricos, Margarita Simón, Sverre Sandberg

Research output: Contribution to journalReview article

Abstract

Background: Biological variation (BV) data can be used to set analytical performance specifications (APS) for lipid assays. Poor performance will impact upon the efficacy of international guidelines for cardiovascular risk assessment (CVR) and relevant clinical decision limits. This systematic review applies the Biological Variation Data Critical Appraisal Checklist (BIVAC) to published studies of BV of CVR biomarkers enabling metanalysis of the data. Methods: Studies of BV of total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and apolipoproteins A1 and B, retrieved using a systematic literature search, were evaluated and graded using the BIVAC. Meta-analysis of CVI and CVG estimates were performed utilizing weightings based upon BIVAC grades and the width of the data confidence intervals. Results: Applying the BIVAC, ten publications were graded as D, 43 as C, 5 as B and 1 as A (fully compliant). A total of 196 CVI and 87 CVG estimates were available for the different lipid measurands. The meta-analysis-derived BV data estimates were generally concordant with those in the online 2014 BV database. Conclusions: Application of BIVAC identifies BV data suitable for many important applications including setting APS. Additionally, this review identifies a need for new BIVAC compliant studies to deliver BV reference data in different subpopulations.

Original languageEnglish
Pages (from-to)467-475
Number of pages9
JournalClinica Chimica Acta
Volume495
DOIs
Publication statusPublished - Aug 2019

Keywords

  • Analytical performance specifications
  • Biological variation
  • Cardiovascular risk
  • Lipids
  • Meta-analysis

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

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    Díaz-Garzón, J., Fernández–Calle, P., Minchinela, J., Aarsand, A. K., Bartlett, W. A., Aslan, B., Boned, B., Braga, F., Carobene, A., Coskun, A., Gonzalez-Lao, E., Jonker, N., Marques-Garcia, F., Perich, C., Ricos, C., Simón, M., & Sandberg, S. (2019). Biological variation data for lipid cardiovascular risk assessment biomarkers. A systematic review applying the biological variation data critical appraisal checklist (BIVAC). Clinica Chimica Acta, 495, 467-475. https://doi.org/10.1016/j.cca.2019.05.013