The European Biological Variation Study (EuBIVAS): a summary report.
EuBIVAS
analytical performance specification
biological variation
reference change values
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
28 03 2022
28 03 2022
Historique:
received:
26
03
2021
accepted:
14
05
2021
pubmed:
29
5
2021
medline:
26
3
2022
entrez:
28
5
2021
Statut:
epublish
Résumé
Biological variation (BV) data have many important applications in laboratory medicine. Concerns about quality of published BV data led the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) 1st Strategic Conference to indicate need for new studies to generate BV estimates of required quality. In response, the EFLM Working Group on BV delivered the multicenter European Biological Variation Study (EuBIVAS). This review summarises the EuBIVAS and its outcomes. Serum/plasma samples were taken from 91 ostensibly healthy individuals for 10 consecutive weeks at 6 European centres. Analysis was performed by Siemens ADVIA 2400 (clinical chemistry), Cobas Roche 8000, c702 and e801 (proteins and tumor markers/hormones respectively), ACL Top 750 (coagulation parameters), and IDS iSYS or DiaSorin Liaison (bone biomarkers). A strict preanalytical and analytical protocol was applied. To determine BV estimates with 95% CI, CV-ANOVA after analysis of outliers, homogeneity and trend analysis or a Bayesian model was applied. EuBIVAS has so far delivered BV estimates for 80 different measurands. Estimates for 10 measurands (non-HDL cholesterol, S100-β protein, neuron-specific enolase, soluble transferrin receptor, intact fibroblast growth-factor-23, uncarboxylated-unphosphorylated matrix-Gla protein, human epididymis protein-4, free, conjugated and %free prostate-specific antigen), prior to EuBIVAS, have not been available. BV data for creatinine and troponin I were obtained using two analytical methods in each case. The EuBIVAS has delivered high-quality BV data for a wide range of measurands. The BV estimates are for many measurands lower than those previously reported, having an impact on the derived analytical performance specifications and reference change values.
Identifiants
pubmed: 34049424
pii: cclm-2021-0370
doi: 10.1515/cclm-2021-0370
doi:
Substances chimiques
Creatinine
AYI8EX34EU
Prostate-Specific Antigen
EC 3.4.21.77
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
505-517Informations de copyright
© 2021 Walter de Gruyter GmbH, Berlin/Boston.
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