title: Multicentre physiological reference intervals for serum concentrations of immunoglobulins A, G and M, complement C3c and C4 measured with Tina-Quant reagents systems.
abstract: BACKGROUND
  Clinical laboratories seeking accreditation for compliance with ISO 15189:2003 need to demonstrate that the physiological reference intervals communicated to all users of the laboratory service are appropriate for the patient population served and for the measurement systems used. In the case of immunological quantities, few articles have been published in peer-reviewed journals.
  
  
  METHODS
  A total of 21 clinical laboratories in different regions of Spain collaborated in identifying reference individuals and determining adult reference intervals for some immunological quantities measured using RD/Hitachi Modular Analytics analysers and Tina-Quant reagent systems. These immunological quantities are the mass concentrations of immunoglobulin A, immunoglobulin G, immunoglobulin M, complement C3c and complement C4 in serum. All the logistic work was carried out in co-operation with the supplier of the reagents and analysers (Roche Diagnostics España, S.L., Sant Cugat del Vallès, Catalonia, Spain). From the set of reference values obtained by each laboratory, multicentre reference limits were estimated non-parametrically.
  
  
  CONCLUSIONS
  The reference intervals estimated in this study for concentrations of serum components under consideration are: complement C3c, 0.62-1.64 g/L for women and men; complement C4, 0.14-0.72 g/L for women and men; immunoglobulin A, 0.89-4.80 g/L for women and men; immunoglobulin G, 6.5-14.3 g/L for women and men; and immunoglobulin M, 0.48-3.38 g/L for women and 0.41-2.46 g/L for men.
authors: Laboratori Clínic, IDIBELL--Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Catalonia, Spain. xfa@csub.scs.es
authors: Xavier
authors: X
authors: Fuentes-Arderiu
authors: Eduardo
authors: E
authors: Alonso-Gregorio
authors: Virtudes
authors: V
authors: Alvarez-Funes
authors: Carmen
authors: C
authors: Ambrós-Marigómez
authors: Lluís
authors: L
authors: Coca-Fábregas
authors: Marta
authors: M
authors: Cruz-Placer
authors: Julián
authors: J
authors: Díaz-Fernández
authors: María Pilar
authors: MP
authors: Pinel-Julián
authors: Beatriz
authors: B
authors: Gutiérrez-Cecchini
authors: Pilar
authors: P
authors: Herrero-Bernal
authors: Marcos
authors: M
authors: Sempere-Alcocer
authors: Francisca
authors: F
authors: García-Caballero
authors: María
authors: M
authors: Del Mar Larrea-Ortiz-Quintana
authors: Pedro
authors: P
authors: La-Torre-Marcellán
authors: María
authors: M
authors: Del Señor López-Vélez
authors: Carmen
authors: C
authors: Mar-Medina
authors: Javier
authors: J
authors: Martín-Oncina
authors: María Victoria
authors: MV
authors: Rodríguez-Hernández
authors: María Victoria
authors: MV
authors: Romero-Sotomayor
authors: Cándido
authors: C
authors: Serrano-López
authors: Adolfo
authors: A
authors: Sicilia-Enríquez-de-Salamanca
authors: Ana María
authors: AM
authors: Velasco-Romero
authors: Santiago
authors: S
authors: Juvé-Cuxart
mesh_terms: D003176:Complement C3 / Q000032:analysis*; D003181:Complement C4 / Q000032:analysis*; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood*; D007074:Immunoglobulin G / Q000097:blood*; D007075:Immunoglobulin M / Q000097:blood*; D007202:Indicators and Reagents; D012016:Reference Values; D013030:Spain
chemical_list: D003176:Complement C3; D003181:Complement C4; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D007202:Indicators and Reagents