TY - JOUR
T1 - Biological variation data for lipid cardiovascular risk assessment biomarkers
T2 - A systematic review applying the biological variation data critical appraisal checklist (BIVAC)
AU - Díaz-Garzón, Jorge
AU - Fernández-Calle, Pilar
AU - Minchinela, Joana
AU - Aarsand, Aasne K.
AU - Bartlett, William A.
AU - Aslan, Berna
AU - Boned, Beatriz
AU - Braga, Federica
AU - Carobene, Anna
AU - Coskun, Abdurrahman
AU - Gonzalez-Lao, Elisabet
AU - Jonker, Niels
AU - Marques-Garcia, Fernando
AU - Perich, Carmen
AU - Ricos, Carmen
AU - Simón, Margarita
AU - Sandberg, Sverre
N1 - Copyright © 2019. Published by Elsevier B.V.
PY - 2019/8/1
Y1 - 2019/8/1
N2 - 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.
AB - 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.
KW - Analytical performance specifications
KW - Biological variation
KW - Cardiovascular risk
KW - Lipids
KW - Meta-analysis
KW - Risk Assessment
KW - Humans
KW - Checklist
KW - Biomarkers/blood
KW - Lipids/blood
KW - Cardiovascular Diseases/blood
UR - http://www.scopus.com/inward/record.url?scp=85066287834&partnerID=8YFLogxK
U2 - 10.1016/j.cca.2019.05.013
DO - 10.1016/j.cca.2019.05.013
M3 - Review article
C2 - 31103621
SN - 0009-8981
VL - 495
SP - 467
EP - 475
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
ER -
