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

    Clinica chimica acta, August 2019, 2019-Aug, 2019-08-00, 20190801, Letnik: 495
    Journal Article

    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. 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. 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. 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. •Reliable biological variation (BV) estimates are necessary for optimal diagnosis and monitoring of cardiovascular risk.•The Biological Variation Data Critical Appraisal Checklist has been applied to systematically evaluate BV studies for lipids•This study provides updated evidence-based estimates of CVI and CVG values for lipids from BIVAC-compliant studies, delivered by meta-analysis•Quality assessed BV data will in the future be made available in the EFLM Biological Variation Database.