Biological variation database, and quality specifications for imprecision, bias and total error . The 2006 update

Carmen Ricós,1,2 José-Vicente García-Lario,1,3 Virtudes Alvarez,1,4 Fernando Cava,1,5 Marivi Domenech,1,6 Amparo Hernández,1,4 Carlos-Victor Jiménez,1,7 Joana Minchinela,1,7 Carmen Perich,1,8,Margarita Simón,1,9 Carmen Biosca10
1Analytical Quality Committee, Spanish Society of Clinical Chemistry and Molecular Pathology (SEQC),
2 Laboratoris Clínics Hospital Universitari Vall d’Hebron (Barcelona),
3 Hospital de Motril (Granada),
4 Laboratori Clínic de l’Hospitalet,
5 Fundación-Hospital Alcorcón (Madrid),
6 Laboratori Clínic Manso (Barcelona),
7 Laboratori Clínic de Badalona,
8 Laboratori Clínic Bon Pastor (Barcelona),
9 Laboratori Intercomarcal Vilafranca del Penedés,
10 Servei de Bioquímica Hospital Germans Trias i Pujol (Badalona)

This is the fourth edition of the analytical quality specifications for 289 analytes, derived from a database compiling articles on the within and between-subject biological variation (BV) components (CVI and CVG, respectively) in healthy subjects.

The first edition was presented at the Stockholm international consensus conference on Strategies to Set Global Analytical Quality Specifications in Laboratory Medicine and was published in the Scan J Clin Lab Invest 1999;59:475-586. It was also published on this website in June 2000. The second and third edition appeared at the end of 2001 and 2003, respectively on this website and were also published in Spanish at httlp://www.seqc.es/bd/vb.html.

This fourth edition has the following changes with respect to the previous edition:


Previous Guest Essays:

Understanding Quality -- Jerry Ehrmeyer 
Approaches to Clinical Laboratory Utilization -- Art Eggert, Ph.D. 
Tips on managing the quality of immunoassays -- R. Neill Carey, Ph.D. 
Defect rates, quality and productivity -- Robert Burnett, Ph.D. 
What's New with CLIA'88, JCAHO & CAP -- Sharon Ehrmeyer, Ph.D. 
European Approaches to Analytical Goal-Setting -- Per Hyltoft Petersen 
QC - The Regulations -- Sharon Ehrmeyer, Ph.D.  
Total Quality Management for Medical Laboratories: A European point of view -- Dr. Pharm. J.C. Libeer, Ph.D., Ph.D.
MV - The Regulations -- Sharon Ehrmeyer, Ph.D.
Biological variation data for setting quality specifications -- Callum G. Fraser, Ph.D.
QC Validation in Veterinary Laboratories -- Kathleen P. Freeman, DVM, MS, Ph.D.
Report of the Norwegian EQA Validator Workshop -- Dr. Heidi Steensland
Trueness and Uncertainty -- Dr Xavier Fuentes Arderiu Ph.D. Pharm.D.
Good Laboratory Practice versus CLIA -- Janine Denis Cook, Ph.D.
Biologic Variation and desirable specifications for quality control --Dr. Carmen Ricos
CLS: Victims of our own Success?-- Diana Mass M.A., CLS(NCA)
Biologic Variation: Principles & Practice --Callum Fraser Ph.D.
Pre-,Post- & Analytical Errors -- David Plaut
Biological Database Update -- Dr. Carmen Ricos et al
Quality Requirements Update 2002 -- Sharon Ehrmeyer, Ph.D.
Are "Scientific Statements" the Scientific Truth? by Callum G. Fraser, Ph.D.



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