Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents
-
Olivier Grunewald
, Benjamin Lopez, Séverine Brabant
, Stéphanie Rogeau , Antoine Deschildre , Vassana Phrommavanh , Marie Lefort , Emmanuelle Moitrot , Dominique Gyselinckx , Anne-Sophie Deleplancque , Guillaume Lefevre , Myriam Labalette und Sylvain Dubucquoi
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.
Acknowledgments
We thank Dr. David Fraser (Biotech Communication SARL, Ploudalmezeau, France) for scientific editing services.
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.
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.
Employment or leadership: None declared.
Honorarium: None declared.
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).
©2018 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorials
- Procalcitonin for diagnosing and monitoring bacterial infections: for or against?
- Is it time to abandon the Nobel Prize?
- In Memoriam
- Norbert Tietz, 13th November 1926–23rd May 2018
- Reviews
- Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis
- Telomere biology and age-related diseases
- Opinion Paper
- Procalcitonin-guided antibiotic therapy: an expert consensus
- Genetics and Molecular Diagnostics
- mRNA expression profile in peripheral blood mononuclear cells based on ADRB1 Ser49Gly and Arg389Gly polymorphisms in essential hypertension — a case-control pilot investigation in South Indian population
- General Clinical Chemistry and Laboratory Medicine
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- Long-term stability of glucose: glycolysis inhibitor vs. gel barrier tubes
- Observational studies on macroprolactin in a routine clinical laboratory
- Anti-streptavidin IgG antibody interference in anti-cyclic citrullinated peptide (CCP) IgG antibody assays is a rare but important cause of false-positive anti-CCP results
- Point-of-care creatinine testing for kidney function measurement prior to contrast-enhanced diagnostic imaging: evaluation of the performance of three systems for clinical utility
- Hematology and Coagulation
- Analytical performance of an automated volumetric flow cytometer for quantitation of T, B and natural killer lymphocytes
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- Reference Values and Biological Variations
- Within-subject biological variation of activated partial thromboplastin time, prothrombin time, fibrinogen, factor VIII and von Willebrand factor in pregnant women
- Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects
- Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents
- Cancer Diagnostics
- Serum carbohydrate sulfotransferase 7 in lung cancer and non-malignant pulmonary inflammations
- Cardiovascular Diseases
- Clinical performance of a new point-of-care cardiac troponin I test
- Diabetes
- Testing for HbA1c, in addition to the oral glucose tolerance test, in screening for abnormal glucose regulation helps to reveal patients with early β-cell function impairment
- Effects of common hemoglobin variants on HbA1c measurements in China: results for α- and β-globin variants measured by six methods
- Infectious Diseases
- Serum procalcitonin concentration within 2 days postoperatively accurately predicts outcome after liver resection
- Predictive value of serum gelsolin and Gc globulin in sepsis – a pilot study
- Cerebrospinal fluid free light chains as diagnostic biomarker in neuroborreliosis
- Letter to the Editor
- Glucose and total protein: unacceptable interference on Jaffe creatinine assays in patients
- Interference of glucose and total protein on Jaffe-based creatinine methods: mind the covolume
- Interference of glucose and total protein on Jaffe based creatinine methods: mind the covolume – reply
- Measuring procalcitonin to overcome heterophilic-antibody-induced spurious hypercalcitoninemia
- Paraprotein interference in the diagnosis of hepatitis C infection
- Timeo apis mellifera and dona ferens: bee sting-induced Kounis syndrome
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- Detection of EDTA-induced pseudo-leukopenia using automated hematology analyzer with VCS technology
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Artikel in diesem Heft
- Frontmatter
- Editorials
- Procalcitonin for diagnosing and monitoring bacterial infections: for or against?
- Is it time to abandon the Nobel Prize?
- In Memoriam
- Norbert Tietz, 13th November 1926–23rd May 2018
- Reviews
- Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis
- Telomere biology and age-related diseases
- Opinion Paper
- Procalcitonin-guided antibiotic therapy: an expert consensus
- Genetics and Molecular Diagnostics
- mRNA expression profile in peripheral blood mononuclear cells based on ADRB1 Ser49Gly and Arg389Gly polymorphisms in essential hypertension — a case-control pilot investigation in South Indian population
- General Clinical Chemistry and Laboratory Medicine
- External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact
- Long-term stability of glucose: glycolysis inhibitor vs. gel barrier tubes
- Observational studies on macroprolactin in a routine clinical laboratory
- Anti-streptavidin IgG antibody interference in anti-cyclic citrullinated peptide (CCP) IgG antibody assays is a rare but important cause of false-positive anti-CCP results
- Point-of-care creatinine testing for kidney function measurement prior to contrast-enhanced diagnostic imaging: evaluation of the performance of three systems for clinical utility
- Hematology and Coagulation
- Analytical performance of an automated volumetric flow cytometer for quantitation of T, B and natural killer lymphocytes
- Lupus anticoagulant testing using two parallel methods detects additional cases and predicts persistent positivity
- Reference Values and Biological Variations
- Within-subject biological variation of activated partial thromboplastin time, prothrombin time, fibrinogen, factor VIII and von Willebrand factor in pregnant women
- Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects
- Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents
- Cancer Diagnostics
- Serum carbohydrate sulfotransferase 7 in lung cancer and non-malignant pulmonary inflammations
- Cardiovascular Diseases
- Clinical performance of a new point-of-care cardiac troponin I test
- Diabetes
- Testing for HbA1c, in addition to the oral glucose tolerance test, in screening for abnormal glucose regulation helps to reveal patients with early β-cell function impairment
- Effects of common hemoglobin variants on HbA1c measurements in China: results for α- and β-globin variants measured by six methods
- Infectious Diseases
- Serum procalcitonin concentration within 2 days postoperatively accurately predicts outcome after liver resection
- Predictive value of serum gelsolin and Gc globulin in sepsis – a pilot study
- Cerebrospinal fluid free light chains as diagnostic biomarker in neuroborreliosis
- Letter to the Editor
- Glucose and total protein: unacceptable interference on Jaffe creatinine assays in patients
- Interference of glucose and total protein on Jaffe-based creatinine methods: mind the covolume
- Interference of glucose and total protein on Jaffe based creatinine methods: mind the covolume – reply
- Measuring procalcitonin to overcome heterophilic-antibody-induced spurious hypercalcitoninemia
- Paraprotein interference in the diagnosis of hepatitis C infection
- Timeo apis mellifera and dona ferens: bee sting-induced Kounis syndrome
- Bacterial contamination of reusable venipuncture tourniquets in tertiary-care hospital
- Detection of EDTA-induced pseudo-leukopenia using automated hematology analyzer with VCS technology
- Early adjustment of antimicrobial therapy after PCR/electrospray ionization mass spectrometry-based pathogen detection in critically ill patients with suspected sepsis
- Thromboelastometry reveals similar hemostatic properties of purified fibrinogen and a mixture of purified cryoprecipitate protein components
- Bicarbonate interference on cobas 6000 c501 chloride ion-selective electrodes