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    Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters
    (WALTER DE GRUYTER GMBH, 2020-01-01) Coskun, Abdurrahman; Braga, Federica; Carobene, Anna; Tejedor Ganduxe, Xavier; Aarsand, Aasne K.; Fernandez-Calle, Pilar; Diaz-Garzon Marco, Jorge; Bartlett, William; Jonker, Niels; Aslan, Berna; Minchinela, Joana; Boned, Beatriz; Gonzalez-Lao, Elisabet; Marques-Garcia, Fernando; Perich, Carmen; Ricos, Carmen; Simon, Margarita; Sandberg, Sverre; Chem, European Federation Clinical
    Background: Interpretation of the complete blood count (CBC) parameters requires reliable biological variation (BV) data. The aims of this study were to appraise the quality of publications reporting BV data for CBC parameters by applying the BV Data Critical Appraisal Checklist (BIVAC) and to deliver global BV estimates based on BIVAC compliant studies. Methods: Relevant publications were identified by a systematic literature search and evaluated for their compliance with the 14 BIVAC criteria, scored as A, B, C or D, indicating decreasing compliance. Global CVI and CVG estimates with 95\% CI were delivered by a meta-analysis approach using data from BIVAC compliant papers (grades A-C). Results: In total, 32 studies were identified
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    Biological Variation of Cardiac Troponins in Health and Disease: A Systematic Review and Meta-analysis
    (OXFORD UNIV PRESS INC, 2021-01-01) Diaz-Garzon, Jorge; Fernandez-Calle, Pilar; Sandberg, Sverre; Ozcurumez, Mustafa; Bartlett, William A.; Coskun, Abdurrahman; Carobene, Anna; Perich, Carmen; Simon, Margarita; Marques, Fernando; Boned, Beatriz; Gonzalez-Lao, Elisabet; Braga, Federica; Aarsand, Aasne K.; Chem, European Federation Clinical; Database, Task Grp Biol Variation
    BACKGROUND: Many studies have assessed the biological variation (BV) of cardiac-specific troponins (cTn), reporting widely varying within-subject BV (CVI) estimates. The aim of this study was to provide metaanalysis-derived BV estimates for troponin I (cTnI) and troponin T (cTnT) for different sampling intervals and states of health. METHODS: Relevant studies were identified by a systematic literature search. Studies were classified according to their methodological quality by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Meta-analyses of BIVAC-compliant studies were performed after stratification by cTn isoform, exclusion of results below the limit of detection, states of health, and sampling interval to deliver reference change values (RCV), index of individuality (II) and analytical performance specifications (APS) for these settings. RESULTS: Sixteen and 15 studies were identified for cTnI and cTnT, respectively, out of which 6 received a BIVAC grade A. Five studies had applied contemporary cTnI assays, but none contemporary cTnT. High-sensitivity (hs-) cTnI and cTnT delivered similar estimates in all settings. Long-term CVI estimates (15.1
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    A checklist for critical appraisal of studies of biological variation
    (2014-01-01) Bartlett, William A.; Braga, Federica; Carobene, Anna; Coskun, Abdurrahman; Prusa, Richard; Fernandez-Calle, Pilar; Roraas, Thomas; Jonker, Neils; Sandberg, Sverre; Grp, Biol Variation Working; Chem, European Federation Clinical
    Data on biological variation are used for many purposes in laboratory medicine but concern exists over the validity of the data reported in some studies. A critical appraisal checklist has been produced by a working group established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) to enable standardised assessment of existing and future publications of biological variation data. The checklist identifies key elements to be reported in studies to enable safe accurate and effective transport of biological variation data sets across healthcare systems. The checklist is mapped to the domains of a minimum data set required to enable this process.
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    Analytical Performance Specifications for Lipoprotein(a), Apolipoprotein B-100, and Apolipoprotein A-I Using the Biological Variation Model in the EuBIVAS Population
    (OXFORD UNIV PRESS INC, 2020-01-01) Clouet-Foraison, Noemie; Marcovina, Santica M.; Guerra, Elena; Aarsand, Aasne K.; Coskun, Abdurrahman; Diaz-Garzon, Jorge; Fernandez-Calle, Pilar; Sandberg, Sverre; Ceriotti, Ferruccio; Carobene, Anna; Chem, European Federation Clinical
    BACKGROUND: With increased interest in lipoprotein(a) (Lp{[}a]) concentration as a target for risk reduction and growing clinical evidence of its impact on cardiovascular disease (CVD) risk, rigorous analytical performance specifications (APS) and accuracy targets for Lp(a) are required. We investigated the biological variation (BV) of Lp(a), and 2 other major biomarkers of CVD, apolipoprotein A-I (apoA-I) and apolipoprotein B-100 (apoB), in the European Biological Variation Study population. METHOD: Serum samples were drawn from 91 healthy individuals for 10 consecutive weeks at 6 European laboratories and analyzed in duplicate on a Roche Cobas 8000 c702. Outlier, homogeneity, and trend analysis were performed, followed by CV-ANOVA to determine BV estimates and their 95\% CIs. These estimates were used to calculate APS and reference change values. For Lp(a), BV estimates were determined on normalized concentration quintiles. RESULTS: Within-subject BV estimates were significantly different between sexes for Lp(a) and between women aged <50 and >50 years for apoA-I and apoB. Lp(a) APS was constant across concentration quintiles and, overall, lower than APS based on currently published data, whereas results were similar for apoA-I and apoB. CONCLUSION: Using a fully Biological Variation Data Critical Appraisal Checklist (BIVAC)-compliant protocol, our study data confirm BV estimates of Lp(a) listed in the European Federation of Clinical Chemistry and Laboratory Medicine database and reinforce concerns expressed in recent articles regarding the suitability of older APS recommendations for Lp(a) measurements. Given the heterogeneity of Lp(a), more BIVAC-compliant studies on large numbers of individuals of different ethnic groups would be desirable.
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    Harmonization initiatives in the generation, reporting and application of biological variation data
    (2018-01-01) Aarsand, Aasne K.; Roraas, Thomas; Bartlett, William A.; Coskun, Abdurrahman; Carobene, Anna; Fernandez-Calle, Pilar; Jonker, Niels; Diaz-Garzon, Jorge; Braga, Federica; Sandberg, Sverre; Chem, European Federation Clinical
    Biological variation (BV) data have many applications in laboratory medicine. However, concern has been raised that some LW estimates in use today may be irrelevant or of unacceptable quality. A number of initiatives have been launched by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and other parties to deliver a more harmonized practice in the generation, reporting and application of BV data. Resulting from a necessary focus upon the veracity of historical BV studies, critical appraisal and meta-analysis of published BV studies is possible through application of the Biological Variation Data Critical Appraisal Checklist (BIVAC), published in 2017. The BIVAC compliant large-scale European Biological Variation Study delivers updated high-quality BV data for a wide range of measurands. Other significant developments include the publication of a Medical Subject Heading term for BV and recommendations for common terminology for reporting of BV data. In the near future, global BV estimates derived from meta-analysis of BIVAC appraised publications will be accessible in a Biological Variation Database at the EFLM website. The availability of these high-quality data, which have many applications that impact on the quality and interpretation of clinical laboratory results, will afford improved patient care.
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    Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects
    (WALTER DE GRUYTER GMBH, 2018-01-01) Coskun, Abdurrahman; Carobene, Anna; Kilercik, Meltem; Serteser, Mustafa; Sandberg, Sverre; Aarsand, Aasne K.; Fernandez-Calle, Pilar; Jonker, Niels; Bartlett, William A.; Diaz-Garzon, Jorge; Huet, Sibel; Kiziltas, Cansu; Dalgakiran, Ilayda; Ugur, Esra; Unsal, Ibrahim; Varia, E.F.L.M. Working Grp Biological
    Background: The complete blood count (CBC) is used to evaluate health status in the contexts of various clinical situations such as anemia, infection, inflammation, trauma, malignancies, etc. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are required. The study aim was to define the BVs of CBC parameters employing a strict protocol. Methods: Blood samples, drawn from 30 healthy subjects (17 females, 13 males) once weekly for 10 weeks, were analyzed using a Sysmex XN 3000 instrument. The data were assessed for normality, trends, outliers and variance homogeneity prior to coefficient of variation (CV)-analysis of variance (ANOVA). Sex-stratified within-subject (CVI) and between-subjects (CVG) BV estimates were determined for 21 CBC parameters. Results: For leukocyte parameters, with the exception of lymphocytes and basophils, significant differences were found between female/male CVI estimates. The mean values of all erythrocyte-, reticulocyte- and platelet parameters differed significantly between the sexes, except for mean corpuscular hemoglobin concentration, mean corpuscular volume and platelet numbers. Most CVI and CVG estimates appear to be lower than those previously published. Conclusions: Our study, based on a rigorous protocol, provides updated and more stringent BV estimates for CBC parameters. Sex stratification of data is necessary when exploring the significance of changes in consecutive results and when setting analytical performance specifications.
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    The European Biological Variation Study (EuBIVAS): Biological Variation Data for Coagulation Markers Estimated by a Bayesian Model
    (OXFORD UNIV PRESS INC, 2021-01-01) Aarsand, Aasne K.; Kristoffersen, Ann Helen; Sandberg, Sverre; Stove, Bard; Coskun, Abdurrahman; Fernandez-Calle, Pilar; Diaz-Garzon, Jorge; Guerra, Elena; Ceriotti, Ferruccio; Jonker, Niels; Roraas, Thomas; Carobene, Anna; Chem, European Federation Clinical
    BACKGROUND: For biological variation (BV) data to be safely used, data must be reliable and relevant to the population in which they are applied. We used samples from the European Biological Variation Study (EuBIVAS) to determine BV of coagulation markers by a Bayesian model robust to extreme observations and used the derived within-participant BV estimates {[}CVP(i)] to assess the applicability of the BV estimates in clinical practice. METHOD: Plasma samples were drawn from 92 healthy individuals for 10 consecutive weeks at 6 European laboratories and analyzed in duplicate for activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, D-dimer, antithrombin (AT), protein C, protein S free, and factor VIII (FVIII). A Bayesian model with Student t likelihoods for samples and replicates was applied to derive CVP(i) and predicted BV estimates with 95\% credibility intervals. RESULTS: For all markers except D-dimer, CVP( i) were homogeneously distributed in the overall study population or in subgroups. Mean within-subject estimates (CVI) were <5\% for APTT, PT, AT, and protein S free, <10\% for protein C and FVIII, and <12\% for fibrinogen. For APTT, protein C, and protein S free, estimates were significantly lower in men than in women <= 50 years. CONCLUSION: For most coagulation markers, a common CVI estimate for men and women is applicable, whereas for APTT, protein C, and protein S free, sex-specific reference change values should be applied. The use of a Bayesian model to deliver individual CVP(i) allows for improved interpretation and application of the data.
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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
    (WALTER DE GRUYTER GMBH, 2020-01-01) Ceriotti, Ferruccio; Diaz-Garzon Marco, Jorge; Fernandez-Calle, Pilar; Maregnani, Alessio; Aarsand, Aasne K.; Coskun, Abdurrahman; Jonker, Niels; Sandberg, Sverre; Carobene, Anna; Chem, European Federation Clinical
    Background: Cardiac 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. Methods: Thirty-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). Results: cTnI 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. Conclusions: This 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.