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Multicentre physiological reference intervals for serum concentrations of immunoglobulins A, G and M, complement C3c
Xavier Fuentes-Arderiu1, Eduardo Alonso-Gregorio, Virtudes Alvarez-Funes
1Laboratori Clínic, IDIBELL--Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Catalonia, Spain. xfa@csub.scs.es
Insights
This study establishes crucial reference intervals for immunoglobulin A, G, M, and complement C3c and C4 in serum for adult populations in Spain. These findings aid clinical laboratories in meeting ISO 15189 accreditation standards for immunological testing.
Area of Science:
- Clinical Chemistry
- Immunology
- Laboratory Medicine
Background:
- ISO 15189:2003 accreditation requires validated physiological reference intervals for laboratory services.
- Establishing appropriate reference intervals for immunological quantities is critical but under-published.
- This study addresses the need for population-specific reference intervals for key serum proteins.
Purpose of the Study:
- To determine adult reference intervals for specific immunological quantities in serum.
- To support clinical laboratories in Spain with ISO 15189 accreditation requirements.
- To provide appropriate reference intervals for immunoglobulin A, G, M, and complement C3c and C4.
Main Methods:
- A multicentre study involving 21 clinical laboratories across Spain.
- Reference individuals were identified and adult reference intervals were determined for serum immunoglobulin A, G, M, and complement C3c and C4.
- Measurements were performed using RD/Hitachi Modular Analytics analysers and Tina-Quant reagent systems.
Main Results:
- Non-parametric estimation of multicentre reference limits was performed.
- Reference intervals were established for complement C3c (0.62-1.64 g/L), complement C4 (0.14-0.72 g/L), immunoglobulin A (0.89-4.80 g/L), immunoglobulin G (6.5-14.3 g/L), and immunoglobulin M (0.48-3.38 g/L for women, 0.41-2.46 g/L for men).
Conclusions:
- The study provides validated reference intervals for key serum immunological components.
- These reference intervals are essential for accurate clinical interpretation and laboratory accreditation.
- This work contributes valuable data for immunological testing in Spain.
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.
Results And 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.
