Multicentre physiological reference intervals for serum concentrations of immunoglobulins A, G and M, complement C3c and C4 measured with Tina-Quant reagents systems.
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.
Fuentes-Arderiu
Xavier
X
Laboratori Clínic, IDIBELL--Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Catalonia, Spain. xfa@csub.scs.es
Alonso-Gregorio
Eduardo
E
Alvarez-Funes
Virtudes
V
Ambrós-Marigómez
Carmen
C
Coca-Fábregas
Lluís
L
Cruz-Placer
Marta
M
Díaz-Fernández
Julián
J
Pinel-Julián
María Pilar
MP
Gutiérrez-Cecchini
Beatriz
B
Herrero-Bernal
Pilar
P
Sempere-Alcocer
Marcos
M
García-Caballero
Francisca
F
Del Mar Larrea-Ortiz-Quintana
María
M
La-Torre-Marcellán
Pedro
P
Del Señor López-Vélez
María
M
Mar-Medina
Carmen
C
Martín-Oncina
Javier
J
Rodríguez-Hernández
María Victoria
MV
Romero-Sotomayor
María Victoria
MV
Serrano-López
Cándido
C
Sicilia-Enríquez-de-Salamanca
Adolfo
A
Velasco-Romero
Ana María
AM
Juvé-Cuxart
Santiago
S
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
D003176:Complement C3; D003181:Complement C4; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D007202:Indicators and Reagents