Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
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Elena García-González
Abstract
Background: Monoclonal (M) components can interfere with the direct bilirubin (D-Bil) assay on the AU Beckman Coulter instrumentation and produce spurious results, such as D-Bil values greater than total bilirubin (T-Bil) or very low/negative D-Bil values. If properly detected, this interference may uncover undiagnosed patients with monoclonal gammopathy (MG).
Methods: We investigated the interference rate on the D-Bil AU assay in serum samples known to contain M proteins along with their isotype and described the protocol set up in our laboratory to help with the diagnosis of MG based on D-Bil spurious results as first indication.
Results: During a period of 4 years, 15.4% (345 of 2235) of serum samples containing M immunoglobulins produced erroneous D-Bil results, although no clear relationship between the magnitude or isotype of the M component and interference could be found. In total 22 new patients were diagnosed with MG based on the analytical artefact with the D-Bil as first indication.
Conclusions: The D-Bil interference from MG on the Beckman AU analysers needs to be made known to laboratories in order to prevent clinical confusion and/or additional workup to explain the origin of anomalous results. Although this information may not add to the management of existing patients with serum paraproteins, it can benefit patients that have not been diagnosed with MG by triggering follow up testing to determine if M components are present.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organisation(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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©2016 by De Gruyter
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Articles in the same Issue
- Frontmatter
- Editorials
- Laboratory analytical quality – the process continues
- Measurement uncertainty – a revised understanding of its calculation and use
- Review
- Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
- Opinion Papers
- Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
- The problem with total error models in establishing performance specifications and a simple remedy
- Measurement uncertainty for clinical laboratories – a revision of the concept
- Uncertainty in measurement and total error – are they so incompatible?
- General Clinical Chemistry and Laboratory Medicine
- Using the hazard ratio to evaluate allowable total error in predictive measurands
- Performance of electrolyte measurements assessed by a trueness verification program
- Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
- Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
- Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
- Patient-performed extraction of faecal calprotectin
- Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
- Reference Values and Biological Variations
- Sex-related differences in the association of ghrelin levels with obesity in adolescents
- Gestation specific reference intervals for thyroid function tests in pregnancy
- Cancer Diagnostics
- SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
- Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
- Letters to the Editor
- Cancer dynamics and the success of cancer screening programs
- Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
- Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
- A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
- Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
- Low serum bilirubin values are associated with pulmonary embolism in a case-control study
- Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
- Adipocytes in venipunctures cause falsely elevated S-100B serum values
- Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
- Theranos phenomenon – part 4: Theranos at an International Conference
