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Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents
Olivier Grunewald1, Benjamin Lopez2,3, Séverine Brabant1
1CHU Lille, Institut d'Immunologie, Lille, France.
Clinical Chemistry and Laboratory Medicine
|April 10, 2018
Summary
This study establishes pediatric reference intervals for Immunoglobulin G (IgG) and IgG subclasses using Optilite® reagents. These findings aid in diagnosing primary immunodeficiencies (PIDs) in children.
Area of Science:
- Clinical Immunology
- Pediatric Laboratory Medicine
Background:
- Immunoglobulin G (IgG) and IgG subclass assays are crucial for diagnosing primary immunodeficiencies (PIDs).
- Existing commercial assays for IgG subclasses use varied calibration methods, necessitating specific reference values for each assay.
- This study aimed to establish pediatric reference intervals for IgG and IgG subclasses using Optilite® reagents, calibrated against the ERM-DA470k certified reference material.
Purpose of the Study:
- To determine reliable pediatric reference intervals for IgG and IgG subclasses.
- To provide a basis for accurate PID diagnosis in children.
- To support laboratory accreditation for IgG subclass measurements using specific reagents.
Main Methods:
- Serum samples from a large cohort of children and adolescents without PIDs were analyzed.
- Reference intervals were calculated for defined pediatric age groups (6 months to 18 years).
- The Clinical and Laboratory Standards Institute's C28-A3c protocol was followed for interval calculation.
Main Results:
- Analysis of 456 serum samples showed a strong correlation between total IgG and the sum of IgG subclasses (r2=0.96).
- No significant gender-specific differences in IgG or IgG subclass levels were observed.
- Observed changes in levels over time align with previous reports, with discrepancies in reference limits attributed to calibration variations.
Conclusions:
- The established reference intervals offer a reliable foundation for diagnosing childhood PIDs.
- These results are vital for laboratories utilizing Optilite® immunoturbidimetric reagents for IgG subclass analysis.
- Awareness of manufacturer-specific reference intervals is essential for laboratory scientists and clinicians.
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