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 (Lead / Corresponding author), 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
Early online date16 May 2019
DOIs
Publication statusPublished - 1 Aug 2019

Fingerprint

Biomarkers
Checklist
Risk assessment
Specifications
Lipids
Cholesterol
Apolipoprotein A-I
Apolipoproteins B
LDL Cholesterol
HDL Cholesterol
Assays
Triglycerides
Meta-Analysis
Publications
Databases
Guidelines
Confidence Intervals

Keywords

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

Cite this

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. / Biological variation data for lipid cardiovascular risk assessment biomarkers : A systematic review applying the biological variation data critical appraisal checklist (BIVAC). In: Clinica Chimica Acta. 2019 ; Vol. 495. pp. 467-475.
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title = "Biological variation data for lipid cardiovascular risk assessment biomarkers: A systematic review applying the biological variation data critical appraisal checklist (BIVAC)",
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.",
keywords = "Analytical performance specifications, Biological variation, Cardiovascular risk, Lipids, Meta-analysis",
author = "Jorge D{\'i}az-Garz{\'o}n and Pilar Fern{\'a}ndez-Calle and Joana Minchinela and Aarsand, {Aasne K.} and Bartlett, {William A.} and Berna Aslan and Beatriz Boned and Federica Braga and Anna Carobene and Abdurrahman Coskun and Elisabet Gonzalez-Lao and Niels Jonker and Fernando Marques-Garcia and Carmen Perich and Carmen Ricos and Margarita Sim{\'o}n and Sverre Sandberg",
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Díaz-Garzón, J, Fernández-Calle, P, Minchinela, J, Aarsand, AK, Bartlett, WA, 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, vol. 495, pp. 467-475. https://doi.org/10.1016/j.cca.2019.05.013

Biological variation data for lipid cardiovascular risk assessment biomarkers : A systematic review applying the biological variation data critical appraisal checklist (BIVAC). / Díaz-Garzón, Jorge; Fernández-Calle, Pilar (Lead / Corresponding author); 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.

In: Clinica Chimica Acta, Vol. 495, 01.08.2019, p. 467-475.

Research output: Contribution to journalReview article

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

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

VL - 495

SP - 467

EP - 475

JO - Clinica Chimica Acta

JF - Clinica Chimica Acta

SN - 0009-8981

ER -