Italian 
English CONTRIBUTI SCIENTIFICI – Scientific Papers
Volume:
Biochimica Clinica 2019; 43(1) 059-066
Pubblicato on-line:
Gennaio 14, 2019
DOI:
10.19186/BC_2019.001
Importanza dell’utilizzo di Biological Variation Data Critical Appraisal Checklist nel disegno sperimentale di studi di variabilità biologica. Valutazione a confronto di due pubblicazioni sulla variabilità biologica della proteina S100βe dell’enolasi neu
AUTORI
1Servizio Medicina di Laboratorio, Ospedale San Raffaele, Milano
2Laboratorio di Chimica Clinica, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milano
3Analytical Quality Commission, Spanish Society of Laboratory Medicine (SEQCML)
4Department of Laboratory Medicine, La Paz University Hospital, Madrid, Spagna
5Metropolitana Nord ClinicalLaboratory (LCMN), GermansTriasiPujolUniversity Hospital, Badalona, Spagna
6Norwegian Porphyria Centre, Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norvegia
7Norwegian Quality Improvement of Laboratory Examinations (NOKLUS), Haraldsplass Deaconess Hospital, Bergen, Norvegia
8Blood Sciences, Ninewells Hospital & Medical School, Scotland, Regno Unito
9Institute for Quality Management in Healthcare (IQMH), Centre for Proficiency Testing, Toronto, Ontario, Canada
10Royo Villanova Hospital, Zaragoza, Spagna
11San Agustin University Hospital, Aviles, Asturias, Spagna
12Acibadem University, School of Medicine, Atasehir, Istanbul, Turchia
13Quality Healthcare Consulting. Grupo ACMS, Madrid, Spagna
14Certe, Wilhelmina ZiekenhuisAssen, Assen, Olanda
15Department of Clinical Biochemistry, University Hospital of Salamanca, Spagna
16Clinic Laboratory Hospital Valld’Hebron, Barcelona, Spagna
18Laboratory de l’Alt Penedés, l’Anoia i el Garraf, Barcelona, Spagna
19Department of Global Health and Primary Care, Faculty of Medicine and Dentistry, University of Bergen, Norvegia
ABSTRACT
The importance of the Biological Variation Data Critical Appraisal Checklist when designing experimental studies on biological variation. Comparison of two papers reporting biological variation results for S100-β and neuron-specific enolase proteins
The Biological Variation Data Critical Appraisal Checklist (BIVAC) has been designed to evaluate biological variation (BV) studies and the reliability of the associated BV estimates. To illustrate its utility, two studies delivering within-subject BV (CVI) data for S100-β protein and neuron-specific enolase (NSE), markers typically used for melanoma and neuroendocrine tumors, respectively, were appraised using BIVAC. Data from the European Biological Variation Study (EuBIVAS) and the recently published Johnson et al. study (ref n 11) were scored using the 14 BIVAC quality items (QI), with alternatives A, B, C and/or D to verify whether the elements required to obtain reliable BV data, were present and appropriately documented. Grade A indicates compliance with all the QIs and D indicates non compliance. The sizes of the confidence interval (CI) around the CVI estimates were also compared. Johnson’s study received a BIVAC grade C, EuBIVAS a grade A. EuBIVAS is a large scale study, with 1609 and 1728 results for NSE and S100-β, respectively. In Johnson’s study, only 40 results were available. The EuBIVAS CVI estimates [NSE, 10.9% (10.3-11.5); S100-β , 10.2% (9.6-10.7)] were clearly lower than Johnson’s CVIs [NSE, 22.1% (9.9-34.3); S100-β, 18.9% (8.5-29.4)]. The overlapping CI between the two estimates are caused by Johnson’s CI being about 20 times larger than the corresponding EuBIVAS CI. It is likely that studies that do not comply with all BIVAC QI deliver less reliable, and possibly too high, CVI estimates. Adherence to the BIVAC ensures safe clinical application of BV estimates.