Startseite Medizin Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents
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Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents

  • Olivier Grunewald , Benjamin Lopez ORCID logo EMAIL logo , Séverine Brabant , Stéphanie Rogeau , Antoine Deschildre , Vassana Phrommavanh , Marie Lefort , Emmanuelle Moitrot , Dominique Gyselinckx , Anne-Sophie Deleplancque , Guillaume Lefevre , Myriam Labalette und Sylvain Dubucquoi
Veröffentlicht/Copyright: 9. April 2018

Abstract

Background:

Immunoglobulin G (IgG) and IgG subclass assays are indicated in patients with suspected primary immunodeficiency (PID). Commercially available assays for IgG subclass determination are calibrated against various preparations, and so specific reference values are required for each of them. Using Optilite® reagents from The Binding Site Group Ltd., we sought to determine the pediatric IgG and IgG subclass reference intervals with respect to the ERM-DA470k certified reference material.

Methods:

Levels of IgG and IgG subclasses were analyzed in serum samples collected from a large cohort of PID-free children and adolescents. Reference intervals were calculated for previously published age groups (6–12 months, 12–18 months, 18 months–2 years, 2–3 years, 3–4 years, 4–6 years, 6–9 years, 9–12 years and 12–18 years), according to the Clinical and Laboratory Standards Institute’s C28-A3c protocol.

Results:

A total of 456 serum samples were analyzed. The correlation between the total IgG and the sum of the IgG subclasses was good (r2=0.96). No statistically significant gender-specific differences were observed. Our results for the changes over time in IgG and IgG subclass levels are consistent with previous reports. The differences between our lower/upper reference limits and those in the literature are probably due to variations in calibration.

Conclusions:

Our present results provide a reliable basis for the diagnosis of PIDs in childhood and for the accreditation of laboratories using Optilite® immunoturbidimetric reagents for IgG subclass measurement. Laboratory scientists and clinicians should be aware of the need for manufacturer-specific IgG subclass reference intervals.


Corresponding author: Benjamin Lopez, MD, CHU Lille, Institut d’Immunologie, Centre de Biologie-Pathologie-Génétique, F-59000 Lille, France, Phone: +33-320-445-572, Fax: +33-320-446-954

Acknowledgments

We thank Dr. David Fraser (Biotech Communication SARL, Ploudalmezeau, France) for scientific editing services.

  1. Author contributions: OG, BL and SB designed the study, analyzed and interpreted the data, and drafted the manuscript. OG, AD, VP and ML contributed to patient recruitment and data acquisition, and critically revised the manuscript. EM and DG were responsible for parts of the data acquisition and helped to critically revise the manuscript. SR, ASD, ML, GL and SD helped to interpret data and revise the manuscript. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: The Binding Site Group Ltd. kindly provided Optilite® kits and reagents, and paid for scientific editing services. Study design, data analysis and manuscript preparation were performed independently of this support. BL received travel and accommodation support (for a congress) from The Binding Site Group Ltd. The authors have no other financial or commercial relationships to declare.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Supplementary Material:

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2018-0001).


Received: 2018-01-02
Accepted: 2018-02-15
Published Online: 2018-04-09
Published in Print: 2018-07-26

©2018 Walter de Gruyter GmbH, Berlin/Boston

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