Analytical validation of the Hevylite assays for M-protein quantification
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Joannes F.M. Jacobs
Abstract
Background:
The heavy/light chain (HLC) immunoassay quantifies the different heavy chain/light chain combinations of each immunoglobulin (Ig) class. This makes the HLC assay suited to quantify monoclonal immunoglobulins (M-protein) and for monitoring of patients with monoclonal gammopathies. This method is particularly advantageous for those samples in which electrophoretic quantification of the M-protein is not possible.
Methods:
In this study we tested the analytical performance of the HLC assay in 166 routine clinical samples and in 27 samples derived from the Dutch external quality assessment (EQA) for M-protein diagnostics (74 participating laboratories). Analytical accuracy was assessed by verification that the sum of the HLC-pairs equaled total Ig concentration. Sensitivity of the HLC assay was determined in a direct method comparison with immunofixation electrophoresis (IFE).
Results:
Comparison of HLC data with routine Ig diagnostics in 27 EQA samples showed very good correlation for both the quantification of polyclonal and monoclonal IgG, IgA and IgM (Pearson correlations [r] were 0.94, 0.99 and 0.99, respectively; slopes were 0.94, 1.07 and 0.98, respectively). The overall concordance between IFE and the HLC ratio was high (93%) with a Cohen κ coefficient of 0.84. Discrepancies between both assays were mainly caused by the higher sensitivity of IFE to detect monoclonality.
Conclusions:
We conclude that the HLC assay is an accurate method to quantify M-proteins that can improve monitoring of M-proteins in the beta fraction that cannot be quantified using electrophoretic techniques.
Acknowledgments
We would like to thank The Binding Site for providing reagents to perform this study. We would like to thank Dr. W.A.T. Slieker for assisting in the initial validation of the Hevylite tests.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: Kits and reagents were financially supported by The Binding Site. JFMJ received an NWO-Veni grant from The Netherlands Organization for Scientific Research (Funder Id: 10.13039/501100003246, #016.136.101) and a grant from the Dutch Cancer Society (Funder Id: 10.13039/501100004622, #10817).
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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©2018 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
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- CSF free light chain identification of demyelinating disease: comparison with oligoclonal banding and other CSF indexes
- Search for new biomarkers of pediatric multiple sclerosis: application of immunoglobulin free light chain analysis
- The importance of detecting anti-DFS70 in routine clinical practice: comparison of different care settings
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- Analytical validation of the Hevylite assays for M-protein quantification
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Free light chains in the cerebrospinal fluid. Do we still need oligoclonal IgG?
- Reviews
- Obese phenotype and natriuretic peptides in patients with heart failure with preserved ejection fraction
- Prognostic value of HE4 in patients with ovarian cancer
- Opinion Paper
- Laboratory hemostasis: from biology to the bench
- Genetics and Molecular Diagnostics
- Multicenter validation study for the certification of a CFTR gene scanning method using next generation sequencing technology
- General Clinical Chemistry and Laboratory Medicine
- IL8 and IL16 levels indicate serum and plasma quality
- “Send & hold” clinical decision support rules improvement to reduce unnecessary testing of vitamins A, E, K, B1, B2, B3, B6 and C
- CSF free light chain identification of demyelinating disease: comparison with oligoclonal banding and other CSF indexes
- Search for new biomarkers of pediatric multiple sclerosis: application of immunoglobulin free light chain analysis
- The importance of detecting anti-DFS70 in routine clinical practice: comparison of different care settings
- Higher D-lactate levels are associated with higher prevalence of small dense low-density lipoprotein in obese adolescents
- LC-MSMS assays of urinary cortisol, a comparison between four in-house assays
- Optimized angiotensin-converting enzyme activity assay for the accurate diagnosis of sarcoidosis
- Quantitative urine test strip reading for leukocyte esterase and hemoglobin peroxidase
- Performance evaluation of cobas HBV real-time PCR assay on Roche cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test
- Systematic comparison of routine laboratory measurements with in-hospital mortality: ICU-Labome, a large cohort study of critically ill patients
- Reference Values and Biological Variations
- Establishing reference intervals for sex hormones and SHBG in apparently healthy Chinese adult men based on a multicenter study
- Plasma midregional proadrenomedullin (MR-proADM) concentrations and their biological determinants in a reference population
- Cancer Diagnostics
- Analytical validation of the Hevylite assays for M-protein quantification
- Cardiovascular Diseases
- Assessing matrix, interferences and comparability between the Abbott Diagnostics and the Beckman Coulter high-sensitivity cardiac troponin I assays
- Infectious Diseases
- Evaluation of a novel prognostic score based on thrombosis and inflammation in patients with sepsis: a retrospective cohort study
- Letters to the Editor
- Independent evaluation using fresh patient samples under real clinical conditions is vital for confirming the suitability and marketability of any new HbA1c assay. An example
- Anti-streptavidin antibodies mimicking heterophilic antibodies in thyroid function tests
- Site-specific DNA methylation detection based on enzyme-linked immunosorbent assay using recombinant methyl-CpG binding protein
- 3q29 microduplication in a small family with complex metabolic phenotype from Southern Italy
- A D1424N mutation in the MYH9 gene results in macrothrombocytopenia and granulocytic inclusion bodies in a Chinese inherited macrothrombocytopenia pedigree
- Evaluation of analytical performance of a chemiluminescence enzyme immunoassay (CLEIA) for cTnI using the automated AIA-CL2400 platform
- Cellular markers of eryptosis are altered in type 2 diabetes
- Platelet serotonin is not elevated in patients with benign head and neck paragangliomas
