The EuBIVAS: Within- and Between-Subject Biological Variation Data for Electrolytes, Lipids, Urea, Uric Acid, Total Protein, Total Bilirubin, Direct Bilirubin, and Glucose

Aarsand, Aasne K.; Díaz-Garzón, Jorge; Fernández–Calle, Pilar; Guerra, Elena; Locatelli, Massimo; Bartlett, William A.; Sandberg, Sverre; Røraas, Thomas; Ceriotti, Ferruccio; Sølvik, Una Ørvim; Sylte, Marit Sverresdotter; Coşkun, Abdurrahman; Serteser, Mustafa; Ünsal, İbrahim; Tosato, Francesca; Plebani, Mario; Jonker, Niels; Barla, Gerhard; Carobene, Anna

doi:10.1373/clinchem.2018.288415

Cited by 82 publications

(51 citation statements)

References 28 publications

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“…To evaluate differences in concentrations between participants from the different countries, data were visually inspected (data not shown). To examine if there was a general trend in the overall concentration over the study period, as described for other measurands in the EuBIVAS [19], and if individuals were at steady state, we calculated the regression of the mean of the 180 duplicate analysis from every blood drawing 1, 2 …. 10 (pooled mean group sample concentrations) versus the blood drawing number [1][2][3][4][5][6][7][8][9][10].…”

Section: Discussionmentioning

confidence: 99%

“…Currently available BV data for cTnI BV have been summarized by Nordenskjöld et al [12] and are mostly based on [1] analysis with a non-commercial analytical system [13], [2] small cohorts of potentially unhealthy individuals [12,14,15] or [3] based on sampling with a short time interval (24 h) [16]. The scope of our study was to estimate the weekly BV of high-sensitive cTnI with two recently released commercial methods targeting different epitopes, Siemens Atellica and Singulex Clarity (Singulex is as of June 2019 no longer on the market), on the well-characterized population of the European Biological Variation Study (EuBIVAS) [17][18][19][20]. The study has been conducted in accordance with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) recommendations [21].…”

Section: Introductionmentioning

confidence: 99%

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The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

Ceriotti

Marco

Fernández–Calle

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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BackgroundCardiac troponins (cTn) are specific markers for cardiac damage and acute coronary syndromes. The availability of new high-sensitivity assays allows cTn detection in healthy people, thus permitting the estimation of biological variation (BV) of cTn. The knowledge of BV is important to define analytical performance specifications (APS) and reference change values (RCVs). The aim of this study was to estimate the within- and between-subject weekly BV (CVI, CVG) of cTnI applying two high-sensitivity cTnI assays, using European Biological Variation Study (EuBIVAS) specimens.MethodsThirty-eight men and 53 women underwent weekly fasting blood drawings for 10 consecutive weeks. Duplicate measurements were performed with Singulex Clarity (Singulex, USA) and Siemens Atellica (Siemens Healthineers, Germany).ResultscTnI was measurable in 99.4% and 74.3% of the samples with Singulex and Atellica assays, respectively. Concentrations were significantly higher in men than in women with both methods. The CVI estimates with 95% confidence interval (CI) were for Singulex 16.6% (15.6–17.7) and for Atellica 13.8% (12.7–15.0), with the observed difference likely being caused by the different number of measurable samples. No significant CVI differences were observed between men and women. The CVG estimates for women were 40.3% and 36.3%, and for men 65.3% and 36.5% for Singulex and Atellica, respectively. The resulting APS and RCVs were similar for the two methods.ConclusionsThis is the first study able to estimate cTnI BV for such a large cohort of well-characterized healthy individuals deriving objective APS and RCV values for detecting significant variations in cTnI serial measurements, even within the 99th percentile.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

Ceriotti

Marco

Fernández–Calle

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…The risk that errors in LDLC measurement or calculation affect the clinical decision is further attenuated by the recommendation that decision to initiate a treatment, or adjusting or shifting to another treatment, should not be taken on one LDLC test, but rather after multiple repeated testing (at least 2 times) to allow averaging for intra-individual (biological) variation [41]. The EFLM Biological Variation Working Group recently revised biological variation data [54,55].…”

Section: Ldlc Test Errors: Are They Clinically Relevant?mentioning

confidence: 99%

Quantifying atherogenic lipoproteins for lipid-lowering strategies: consensus-based recommendations from EAS and EFLM

Langlois

Nordestgaard

Langsted

et al. 2019

Clinical Chemistry and Laboratory Medicine (CCLM)

148

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The joint consensus panel of the European Atherosclerosis Society (EAS) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) recently addressed present and future challenges in the laboratory diagnostics of atherogenic lipoproteins. Total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDLC), LDL cholesterol (LDLC), and calculated non-HDLC (=total – HDLC) constitute the primary lipid panel for estimating risk of atherosclerotic cardiovascular disease (ASCVD) and can be measured in the nonfasting state. LDLC is the primary target of lipid-lowering therapies. For on-treatment follow-up, LDLC shall be measured or calculated by the same method to attenuate errors in treatment decisions due to marked between-method variations. Lipoprotein(a) [Lp(a)]-cholesterol is part of measured or calculated LDLC and should be estimated at least once in all patients at risk of ASCVD, especially in those whose LDLC declines poorly upon statin treatment. Residual risk of ASCVD even under optimal LDL-lowering treatment should be also assessed by non-HDLC or apolipoprotein B (apoB), especially in patients with mild-to-moderate hypertriglyceridemia (2–10 mmol/L). Non-HDLC includes the assessment of remnant lipoprotein cholesterol and shall be reported in all standard lipid panels. Additional apoB measurement can detect elevated LDL particle (LDLP) numbers often unidentified on the basis of LDLC alone. Reference intervals of lipids, lipoproteins, and apolipoproteins are reported for European men and women aged 20–100 years. However, laboratories shall flag abnormal lipid values with reference to therapeutic decision thresholds.

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“…This model has been validated against traditional methods and has demonstrated to yield similar BV estimates. To perform these comparisons, Røraas et al [14] used the data obtained in the EuBIVAS study for chloride and triglycerides [15]. In other words, this model has already been validated with real BV data from robust studies, which guarantees the validity of this approach.…”

Section: Bayesian Modelmentioning

confidence: 99%

Models to estimate biological variation components and interpretation of serial results: strengths and limitations

Marco

Fernández–Calle

Ricós³

2020

Advances in Laboratory Medicine / Avances en Medicina De Laboratorio

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Biological variation (BV) has multiple applications in a variety of fields of clinical laboratory. The use of BV in statistical modeling is twofold. On the one hand, some models are used for the generation of BV estimates (within- and between-subject variability). Other models are built based on BV in combination with other factors to establish ranges of normality that will help the clinician interpret serial results for the same subject. There are two types of statistical models for the calculation of BV estimates: A. Direct methods, prospective studies designed to calculate BV estimates; i. Classic model: developed by Harris and Fraser, revised by the Working Group on Biological Variation of the European Federation of Laboratory Medicine. ii. Mixed-effect models. iii. Bayesian model. B. Indirect methods, retrospective studies to derive BV estimates from large databases of results. Big data. Understanding the characteristics of these models is crucial as they determine their applicability in different settings and populations. Models for defining ranges that help in the interpretation of individual serial results include: A. Reference change value and B. Bayesian data network. In summary, this review provides an overview of the models used to define BV components and others for the follow-up of patients. These models should be exploited in the future to personalize and improve the information provided by the clinical laboratory and get the best of the resources available.

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The EuBIVAS: Within- and Between-Subject Biological Variation Data for Electrolytes, Lipids, Urea, Uric Acid, Total Protein, Total Bilirubin, Direct Bilirubin, and Glucose

Cited by 82 publications

References 28 publications

The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

The European Biological Variation Study (EuBIVAS): weekly biological variation of cardiac troponin I estimated by the use of two different high-sensitivity cardiac troponin I assays

Quantifying atherogenic lipoproteins for lipid-lowering strategies: consensus-based recommendations from EAS and EFLM

Models to estimate biological variation components and interpretation of serial results: strengths and limitations

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