Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter March 1, 2007

Multicentre physiological reference intervals for serum concentrations of immunoglobulins A, G and M, complement C3c and C4 measured with Tina-Quant® reagents systems

  • Xavier Fuentes-Arderiu , Eduardo Alonso-Gregorio , Virtudes Álvarez-Funes , Carmen Ambrós-Marigómez , Lluís Coca-Fábregas , Marta Cruz-Placer , Julián Díaz-Fernández , María Pilar Pinel-Julián , Beatriz Gutiérrez-Cecchini , Pilar Herrero-Bernal , Marcos Sempere-Alcocer , Francisca García-Caballero , María del Mar Larrea-Ortiz-Quintana , Pedro La-Torre-Marcellán , María del Señor López-Vélez , Carmen Mar-Medina , Javier Martín-Oncina , María Victoria Rodríguez-Hernández , María Victoria Romero-Sotomayor , Cándido Serrano-López , Adolfo Sicilia-Enríquez-de-Salamanca , Ana María Velasco-Romero and Santiago Juvé-Cuxart

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.

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. (According to ISO, IUPAC and IFCC recommendations, the comma is used as the decimal sign.)

Clin Chem Lab Med 2007;45:387–90.

:

Corresponding author: Xavier Fuentes-Arderiu, Laboratori Clínic, IDIBELL—Hospital Universitari de Bellvitge, Feixa Llarga s/n, 08907 l'Hospitalet de Llobregat, Catalonia, Spain Fax: +34-93-2607546,

References

1. National Center for Biotechnology Information. PubMed http://www.ncbi.nlm.nih.gov/entrez/query.fcgi. Accessed October 3, 2006.Search in Google Scholar

2. Herbeth B, Henny J, Siest G. Variations biologiques et valeurs de référence de transferrine, immunoglobuline A et orosomucoïde. Ann Biol Clin1983;41:23–32.Search in Google Scholar

3. Berth M, Delanghe J, Langlois M, De Irjala K, Koskinen P, Icen A, et al. Reference intervals for immunoglobulins IgA, IgG and IgM in serum in adults and in children aged 6 months to 14 years. Scand J Clin Lab Invest1990;50:573–7.10.1080/00365519009089173Search in Google Scholar PubMed

4. Buyzere M. Reference values of serum IgA subclasses in Caucasian adults by immunonephelometry. Clin Chem1999;45:309–10.10.1093/clinchem/45.2.309Search in Google Scholar

5. Bäck SE, Nilsson JE, Fex G, Jeppson JO, Rosén U, Tryding N, et al. Towards Common Reference Intervals in Clinical Chemistry. An attempt at harmonization between three hospital laboratories in Skåne, Sweden. Clin Chem Lab Med1999;37:573–92.10.1515/CCLM.1999.091Search in Google Scholar PubMed

6. International Organization for Standardization. Medical laboratories – particular requirements for quality and competence. ISO 15189. Geneva: ISO, 2003.Search in Google Scholar

7. Fuentes-Arderiu X, Mas-Serra R, Alumà-Trullà A, Martí-Marcet MI, Dot-Bach D. Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences. Clin Chem Lab Med2004;42:778–82.10.1515/CCLM.2004.130Search in Google Scholar PubMed

8. International Federation of Clinical Chemistry, International Committee for Standardization in Hematology. Approved recommendation on the theory of reference values. J Clin Chem Clin Biochem 1987;25:337–42; J Clin Chem Clin Biochem 1987;25:639–44; J Clin Chem Clin Biochem 1987;25:645–56; J Clin Chem Clin Biochem 1987;25:657–62; J Clin Chem Clin Biochem 1988;26:593–8; Eur J Clin Chem Clin Biochem 1991;29:531–5.Search in Google Scholar

9. Strike PW. Statistical methods in laboratory medicine. Oxford: Butterworth-Heinemann, 1991.Search in Google Scholar

10. Harris EK, Boyd JC. On dividing reference data into subgroups to produce separate reference ranges. Clin Chem1990;36:265–70.10.1093/clinchem/36.2.265Search in Google Scholar

11. Harris EK, Boyd JC. Statistical bases of reference values in laboratory medicine. New York: Marcel Dekker, 1995:77–90.10.1201/9781482273151Search in Google Scholar

12. Conover WJ. Practical nonparametric statistics, 2nd ed. New York: Wiley, 1980:229–37.Search in Google Scholar

13. Dixon DJ. Processing data for outliers. Biometrics1953;9:74–89.10.2307/3001634Search in Google Scholar

14. Henderson AR. Testing experimental data for univariate normality. Clin Chim Acta2006;366:112–29.10.1016/j.cca.2005.11.007Search in Google Scholar PubMed

15. Bundesärztekammer (Arbeitsgemeinschaft der Deutschen Ärztekammern). Richtline der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriumsmidizinischer Untersuchungen. Beschluss des Vorstandes der Bundesärztekammer. http://www.bundesaerztekammer.de/30/Ritchtlinien/Richtidx/Labor2002/RiliLabor.pdf, accessed December 8, 2006.Search in Google Scholar

16. Gowans EMS, Hyltoft Petersen P, Blaaberg O, Hørder M. Analytical goals for the acceptance of common reference intervals for laboratories throughout a geographical area. Scand J Clin Lab Invest1988;48:757–64.10.3109/00365518809088757Search in Google Scholar PubMed

17. Blaabjerg O, Hyltoft Petersen P, Blom M, Irjala K, Uldall A, Gry H, et al. Common reference intervals for plasma proteins in the Nordic countries. Upsala J Med Sci1994;99:357–62.10.3109/03009739409179379Search in Google Scholar

18. Ferré-Masferrer M, Fuentes-Arderiu X, Álvarez-Funes V, Güell-Miró R, Castiñeiras-Lacambra MJ. Multicentric reference values: shared reference limits. Eur J Clin Chem Clin Biochem1997;35:715–8.Search in Google Scholar

19. Bäck SE, Nilsson JE, Fex G, Jeppson JO, Rosén U, Tryding N, et al. Towards common reference intervals in clinical chemistry. Clin Chem Lab Med1999;37:573–92.10.1515/CCLM.1999.091Search in Google Scholar PubMed

20. Andrew CH, Hanning I, McBain AM, Moody D, Price A. A model for a multicentre approach to the derivation of reference intervals for thyroid hormones and testosterone for laboratories using identical analysers. Clin Chem Lab Med2000;38:1013–9.10.1515/CCLM.2000.150Search in Google Scholar PubMed

21. Rustard P, Felding P, Lahti A. Proposal for guidelines to establish common biological reference intervals in large geographical areas for biochemical quantities measured frequently in serum and plasma. Clin Chem Lab Med2004;42:783–91.10.1515/CCLM.2004.131Search in Google Scholar PubMed

22. Fuentes-Arderiu X. Biological reference intervals and ISO 15189. Clin Chim Acta2006;364:365–6.10.1016/j.cca.2005.07.014Search in Google Scholar PubMed

Published Online: 2007-03-01
Published in Print: 2007-03-01

©2007 by Walter de Gruyter Berlin New York

Downloaded on 28.3.2024 from https://www.degruyter.com/document/doi/10.1515/CCLM.2007.069/html
Scroll to top button