European Biological Variation Study (EuBIVAS): Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins

European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation, Anna Carobene, Aasne K. Aarsand, Elena Guerra, William A. Bartlett, Abdurrahman Coşkun, Jorge Díaz-Garzón, Pilar Fernandez-Calle, Niels Jonker, Massimo Locatelli, Sverre Sandberg, Ferruccio Ceriotti

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

BACKGROUND: The European Biological Variation Study (EuBIVAS) was established to deliver rigorously determined data for biological variation (BV). Here, EuBIVAS-based BV estimates are provided for α1-acid glycoprotein, α1-antitrypsin, albumin, β2-microglobulin, ceruloplasmin, complement component 3, complement component 4, C-reactive protein (CRP), cystatin C, haptoglobin, IgA, IgG, IgM, soluble transferrin receptor (sTfR), and transferrin (Trf), together with their associated analytical performance specifications (APSs) and reference change values (RCVs). METHOD: Serum samples from weekly blood samplings of 91 healthy study participants (38 males and 53 females, ages 21-69 years old) over 10 consecutive weeks in 6 European laboratories were stored at -80 °C before duplicate analysis on a Roche Cobas c702. Outlier and variance homogeneity analyses were performed followed by CV-ANOVA on trend-corrected data if relevant, to determine BV and analytical variation estimates with CI and the associated RCV. RESULTS: For the acute phase proteins, several participants experienced mild inflammatory episodes during the study, requiring exclusion of 7% of the 25290 results. Within-subject BV (CVI) estimates for specific proteins obtained in our study were lower than those available in the online 2014 BV database, except for Trf, whereas between-subject BV (CVG) estimates were similar. CVI and CVG estimates for sTfR, which have not previously been published, were 6.0% and 19.1%, respectively. CONCLUSIONS: In addition to new BV estimates for sTfR, this EuBIVAS substudy generated more demanding APS for frequently requested plasma specific proteins. APS for CRP should not be calculated from BV data except when CRP is used as a risk factor for cardiovascular disease.

Original languageEnglish
Pages (from-to)1031-1041
Number of pages11
JournalClinical Chemistry
Volume65
Issue number8
DOIs
Publication statusPublished - Aug 1 2019

Fingerprint

Transferrin Receptors
C-Reactive Protein
Transferrin
Specifications
Analysis of Variance
Reference Values
Complement C4
Cystatin C
Complement C3
Proteins
Ceruloplasmin
Haptoglobins
Acute-Phase Proteins
Analysis of variance (ANOVA)
Protein C
Immunoglobulin A
Immunoglobulin M
Blood Proteins
Albumins
Glycoproteins

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation, Carobene, A., Aarsand, A. K., Guerra, E., Bartlett, W. A., Coşkun, A., ... Ceriotti, F. (2019). European Biological Variation Study (EuBIVAS): Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins. Clinical Chemistry, 65(8), 1031-1041. https://doi.org/10.1373/clinchem.2019.304618

European Biological Variation Study (EuBIVAS) : Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins. / European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation ; Carobene, Anna; Aarsand, Aasne K.; Guerra, Elena; Bartlett, William A.; Coşkun, Abdurrahman; Díaz-Garzón, Jorge; Fernandez-Calle, Pilar; Jonker, Niels; Locatelli, Massimo; Sandberg, Sverre; Ceriotti, Ferruccio.

In: Clinical Chemistry, Vol. 65, No. 8, 01.08.2019, p. 1031-1041.

Research output: Contribution to journalArticle

European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation, Carobene, A, Aarsand, AK, Guerra, E, Bartlett, WA, Coşkun, A, Díaz-Garzón, J, Fernandez-Calle, P, Jonker, N, Locatelli, M, Sandberg, S & Ceriotti, F 2019, 'European Biological Variation Study (EuBIVAS): Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins', Clinical Chemistry, vol. 65, no. 8, pp. 1031-1041. https://doi.org/10.1373/clinchem.2019.304618
European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation, Carobene A, Aarsand AK, Guerra E, Bartlett WA, Coşkun A et al. European Biological Variation Study (EuBIVAS): Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins. Clinical Chemistry. 2019 Aug 1;65(8):1031-1041. https://doi.org/10.1373/clinchem.2019.304618
European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation ; Carobene, Anna ; Aarsand, Aasne K. ; Guerra, Elena ; Bartlett, William A. ; Coşkun, Abdurrahman ; Díaz-Garzón, Jorge ; Fernandez-Calle, Pilar ; Jonker, Niels ; Locatelli, Massimo ; Sandberg, Sverre ; Ceriotti, Ferruccio. / European Biological Variation Study (EuBIVAS) : Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins. In: Clinical Chemistry. 2019 ; Vol. 65, No. 8. pp. 1031-1041.
@article{843182b8c5f44bf49f875d8914bc2382,
title = "European Biological Variation Study (EuBIVAS): Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins",
abstract = "BACKGROUND: The European Biological Variation Study (EuBIVAS) was established to deliver rigorously determined data for biological variation (BV). Here, EuBIVAS-based BV estimates are provided for α1-acid glycoprotein, α1-antitrypsin, albumin, β2-microglobulin, ceruloplasmin, complement component 3, complement component 4, C-reactive protein (CRP), cystatin C, haptoglobin, IgA, IgG, IgM, soluble transferrin receptor (sTfR), and transferrin (Trf), together with their associated analytical performance specifications (APSs) and reference change values (RCVs). METHOD: Serum samples from weekly blood samplings of 91 healthy study participants (38 males and 53 females, ages 21-69 years old) over 10 consecutive weeks in 6 European laboratories were stored at -80 °C before duplicate analysis on a Roche Cobas c702. Outlier and variance homogeneity analyses were performed followed by CV-ANOVA on trend-corrected data if relevant, to determine BV and analytical variation estimates with CI and the associated RCV. RESULTS: For the acute phase proteins, several participants experienced mild inflammatory episodes during the study, requiring exclusion of 7{\%} of the 25290 results. Within-subject BV (CVI) estimates for specific proteins obtained in our study were lower than those available in the online 2014 BV database, except for Trf, whereas between-subject BV (CVG) estimates were similar. CVI and CVG estimates for sTfR, which have not previously been published, were 6.0{\%} and 19.1{\%}, respectively. CONCLUSIONS: In addition to new BV estimates for sTfR, this EuBIVAS substudy generated more demanding APS for frequently requested plasma specific proteins. APS for CRP should not be calculated from BV data except when CRP is used as a risk factor for cardiovascular disease.",
author = "{European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation} and Anna Carobene and Aarsand, {Aasne K.} and Elena Guerra and Bartlett, {William A.} and Abdurrahman Coşkun and Jorge D{\'i}az-Garz{\'o}n and Pilar Fernandez-Calle and Niels Jonker and Massimo Locatelli and Sverre Sandberg and Ferruccio Ceriotti",
year = "2019",
month = "8",
day = "1",
doi = "10.1373/clinchem.2019.304618",
language = "English",
volume = "65",
pages = "1031--1041",
journal = "Clinical Chemistry",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "8",

}

TY - JOUR

T1 - European Biological Variation Study (EuBIVAS)

T2 - Within- and Between-Subject Biological Variation Data for 15 Frequently Measured Proteins

AU - European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation

AU - Carobene, Anna

AU - Aarsand, Aasne K.

AU - Guerra, Elena

AU - Bartlett, William A.

AU - Coşkun, Abdurrahman

AU - Díaz-Garzón, Jorge

AU - Fernandez-Calle, Pilar

AU - Jonker, Niels

AU - Locatelli, Massimo

AU - Sandberg, Sverre

AU - Ceriotti, Ferruccio

PY - 2019/8/1

Y1 - 2019/8/1

N2 - BACKGROUND: The European Biological Variation Study (EuBIVAS) was established to deliver rigorously determined data for biological variation (BV). Here, EuBIVAS-based BV estimates are provided for α1-acid glycoprotein, α1-antitrypsin, albumin, β2-microglobulin, ceruloplasmin, complement component 3, complement component 4, C-reactive protein (CRP), cystatin C, haptoglobin, IgA, IgG, IgM, soluble transferrin receptor (sTfR), and transferrin (Trf), together with their associated analytical performance specifications (APSs) and reference change values (RCVs). METHOD: Serum samples from weekly blood samplings of 91 healthy study participants (38 males and 53 females, ages 21-69 years old) over 10 consecutive weeks in 6 European laboratories were stored at -80 °C before duplicate analysis on a Roche Cobas c702. Outlier and variance homogeneity analyses were performed followed by CV-ANOVA on trend-corrected data if relevant, to determine BV and analytical variation estimates with CI and the associated RCV. RESULTS: For the acute phase proteins, several participants experienced mild inflammatory episodes during the study, requiring exclusion of 7% of the 25290 results. Within-subject BV (CVI) estimates for specific proteins obtained in our study were lower than those available in the online 2014 BV database, except for Trf, whereas between-subject BV (CVG) estimates were similar. CVI and CVG estimates for sTfR, which have not previously been published, were 6.0% and 19.1%, respectively. CONCLUSIONS: In addition to new BV estimates for sTfR, this EuBIVAS substudy generated more demanding APS for frequently requested plasma specific proteins. APS for CRP should not be calculated from BV data except when CRP is used as a risk factor for cardiovascular disease.

AB - BACKGROUND: The European Biological Variation Study (EuBIVAS) was established to deliver rigorously determined data for biological variation (BV). Here, EuBIVAS-based BV estimates are provided for α1-acid glycoprotein, α1-antitrypsin, albumin, β2-microglobulin, ceruloplasmin, complement component 3, complement component 4, C-reactive protein (CRP), cystatin C, haptoglobin, IgA, IgG, IgM, soluble transferrin receptor (sTfR), and transferrin (Trf), together with their associated analytical performance specifications (APSs) and reference change values (RCVs). METHOD: Serum samples from weekly blood samplings of 91 healthy study participants (38 males and 53 females, ages 21-69 years old) over 10 consecutive weeks in 6 European laboratories were stored at -80 °C before duplicate analysis on a Roche Cobas c702. Outlier and variance homogeneity analyses were performed followed by CV-ANOVA on trend-corrected data if relevant, to determine BV and analytical variation estimates with CI and the associated RCV. RESULTS: For the acute phase proteins, several participants experienced mild inflammatory episodes during the study, requiring exclusion of 7% of the 25290 results. Within-subject BV (CVI) estimates for specific proteins obtained in our study were lower than those available in the online 2014 BV database, except for Trf, whereas between-subject BV (CVG) estimates were similar. CVI and CVG estimates for sTfR, which have not previously been published, were 6.0% and 19.1%, respectively. CONCLUSIONS: In addition to new BV estimates for sTfR, this EuBIVAS substudy generated more demanding APS for frequently requested plasma specific proteins. APS for CRP should not be calculated from BV data except when CRP is used as a risk factor for cardiovascular disease.

UR - http://www.scopus.com/inward/record.url?scp=85070788750&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85070788750&partnerID=8YFLogxK

U2 - 10.1373/clinchem.2019.304618

DO - 10.1373/clinchem.2019.304618

M3 - Article

C2 - 31171528

AN - SCOPUS:85070788750

VL - 65

SP - 1031

EP - 1041

JO - Clinical Chemistry

JF - Clinical Chemistry

SN - 0009-9147

IS - 8

ER -