Advertisement

Accreditation and Quality Assurance

, Volume 9, Issue 1–2, pp 112–114 | Cite as

Physiological reference values: a shared business? Report of the second European symposium on clinical laboratory and in vitro diagnostics industry

  • Núria Monge-Azemar
  • Luz María Cruz-Carlos
  • Xavier Fuentes-ArderiuEmail author
Meeting Report
  • 59 Downloads

Abstract

The Catalan Association of Clinical Laboratory Sciences, with the support of its corporative members, organized the second European symposium devoted to physiological reference values, in Barcelona. The objectives were: (i) to discuss ways to develop a common strategy among clinical laboratories and the in vitro diagnostic (IVD) industry for the generation of physiological reference values related to biological quantities of medical interest; and (ii) to establish consensus between both groups regarding the interpretation of the requirements related to physiological reference values contained in the European (EU) Directive 98/79-EC and in the EN-ISO 15189:2003 standard. The symposium was divided into four parts in which different aspects of the reference values were discussed: legal and normative aspects, alternatives to the production of own reference values, methodology, and diffusion and teaching. The main conclusions were the need to clarify the requirements described by the EU Directive 98/79-EC and EN-ISO 15189:2003 regarding reference values, and the need for cooperation between industry, clinical laboratories, and health authorities to achieve common reference intervals, including multicentric reference intervals.

Keywords

Reference values IVD industry EU Directive 98/79-EC EN-ISO 15189:2003 

References

  1. 1.
    European Parliament, Council of European Union. Directive 98/79 of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Official Journal of European Communities 1998;(7.12.98):L331/1-L331/37Google Scholar
  2. 2.
    ISO 15189 (2003) Medical laboratories—particular requirements for quality and competence. International Organization for Standardization (ISO), GenevaGoogle Scholar
  3. 3.
    Ferré-Masferrer M, Fuentes-Arderiu X, Gomà-Llongueras M, Alumà-Trullàs A, Aramendi-Ramos M, Castaño-Vidriales JL, Esteban-Salan M, Graells-Ferrer M, Jiménez-González A, Jiménez-Lobo C, López-Esparza M, Parés-Pollán L, Regúlez-Uranga M, Riesco-Prieto M, Rodríguez-Camba A, Vidal-Martínez J (2001) Clin Chem Lab Med 39:166–169PubMedGoogle Scholar
  4. 4.
    Fuentes-Arderiu X, Ferré-Masferrer, M, González-Alba JM, Escolà-Aliberas J, Balsells-Roselló D, Blanco-Cristobal C, González-Cruz E, Ibarz-Escuer M, Latorre-Marcellán P, Lugo-Arocena J, Mar-Medina C, Muros-de-Fuentes M, Vicens-Manero M (2001) Scand J Clin Lab Invest 61:273–276CrossRefPubMedGoogle Scholar
  5. 5.
    Fuentes-Arderiu X, Ferré-Masferrer, González-Alba JM, Villarino-González MI, Arrimadas-Esteban E, Cabrero-Olivé D, Cándenas-Arroyo M, García-García D, García-Lario JV, Idoate-Cervantes I, León-López C, López-Lazareno N, Mar-Medina C, Martí-Marcet I, Mauri-Dot M, Pérez-Valero V, Reta-Manterola A, Sánchez-Eixeres MR (2001) Clin Chim Acta 304:143–146CrossRefPubMedGoogle Scholar
  6. 6.
    Harris EK, Boyd JC (1990) Clin Chem 36:265–270PubMedGoogle Scholar
  7. 7.
    Harris EK, Boyd JC (1995) Statistical bases of reference values in laboratory medicine. Dekker, New YorkGoogle Scholar
  8. 8.
    International Federation of Clinical Chemistry, International Committee for Standardization in Haematology. Approved recommendation (1987) Clin Chim Acta 170:S13-S32Google Scholar

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  • Núria Monge-Azemar
    • 1
  • Luz María Cruz-Carlos
    • 1
  • Xavier Fuentes-Arderiu
    • 1
    Email author
  1. 1.Servei de Bioquímica ClínicaHospital Universitari de BellvitgeCataloniaSpain

Personalised recommendations