A statistical basis for harmonization of thyroid stimulating hormone immunoassays using a robust factor analysis model
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Dietmar Stöckl
Abstract
Background: Between-method equivalence ideally is achieved by calibration against an SI-traceable reference measurement procedure. For measurement of thyroid stimulating hormone (TSH), it is unlikely to accomplish this goal in mid-term. Therefore, we investigated a statistical alternative based on a factor analysis (FA) model.
Methods: The FA model was applied to TSH results for 94 samples generated by 14 immunoassays (concentration range: 0.0005–78 mIU/L). The dataset did not fulfill the assumption of a homogeneous sample from an elliptically symmetric distribution, and, therefore, required standardization prior to application of the FA model. As outliers and missing values also occurred, the key quantities of the FA model had to be estimated with a method that can handle these complications. We selected a robust alternating regressions (RAR) method, which replaces in the minimization criterion of the fitting process the squared differences between results xij and model fit
Results: The quality of the estimated targets was reflected by their central position in the distributions, and description of the relationship between results and targets by a simple two-parameter regression equation with high correlation coefficients and low SDs of the percentage-residuals. Mathematical recalibration eliminated the method differences and improved the between-method CV from 11% to 6%.
Conclusions: RAR applied to a multimethod comparison dataset hampered by outliers and missing values, is fit to the purpose of harmonization.
Acknowledgments
The authors are indebted to the IFCCs Committee for Standardization of Thyroid Functions Test and the partners from the in-vitro diagnostic industry for the inspirational support to conduct this statistical study.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research support played no role in thestudy design; in the collection, analysis, and interpretationof data; in the writing of the report; or in the decision tosubmit the report for publication.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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©2014 by Walter de Gruyter Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Diagnosis of diabetes mellitus: reiterated responsibilities for the clinical laboratory
- Review
- The association between plasminogen activator inhibitor type 1 (PAI-1) levels, PAI-1 4G/5G polymorphism, and myocardial infarction: a Mendelian randomization meta-analysis
- Opinion Papers
- Harmonization of quality indicators in laboratory medicine. A preliminary consensus
- Cardiac biomarkers and risk assessment in patients undergoing major non-cardiac surgery: time to revise the guidelines?
- General Clinical Chemistry and Laboratory Medicine
- A statistical basis for harmonization of thyroid stimulating hormone immunoassays using a robust factor analysis model
- Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target
- Combined light chain immunofixation to detect monoclonal gammopathy: a comparison to standard electrophoresis in serum and urine
- Automated indirect immunofluorescence microscopy enables the implementation of a quantitative internal quality control system for anti-nuclear antibody (ANA) analysis
- Peripheral blood lymphocytes from patients with bipolar disorder demonstrate apoptosis and differential regulation of advanced glycation end products and S100B
- Coefficient of energy balance, a new parameter for basic investigation of the cerebrospinal fluid
- Interconversion of stone composition profiles from two recurrent stone episodes in stone formers
- Reference Values
- Complete blood count reference intervals and age- and sex-related trends of North China Han population
- Cancer Diagnostics
- The quantification of HER2 and MYC gene fragments in cell-free plasma as putative biomarkers for gastric cancer diagnosis
- Cardiovascular Diseases
- Novel sensitive cardiac troponin I immunoassay free from troponin I-specific autoantibody interference
- Interleukin-6 receptor Asp358Ala gene polymorphism is associated with plasma C-reactive protein levels and severity of aortic valve stenosis
- Diabetes
- Stability of glucose in plasma with different anticoagulants
- Plasma glucose measurement in diabetes: impact and implications of variations in sample collection procedures with a focus on the first hour after sample collection
- Changing from glucose to HbA1c for diabetes diagnosis: predictive values of one test and importance of analytical bias and imprecision
- System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems
- Letter to the Editors
- Reply to the article entitled “Identification of an 18 bp deletion in the TWIST1 gene by CO-amplification at lower denaturation temperature-PCR (COLD-PCR) for non-invasive prenatal diagnosis of craniosynostosis: first case report” by Galbiati et al., Clin Chem Lab Med 2014;52(4):505–9
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- Sensible use of laboratory testing requires active laboratory involvement
- Digoxin overdose – an accurate method for determining free digoxin concentrations on general chemistry analysers post DigiFab treatment
- Method-specific differences in β-isomerised carboxy-terminal cross-linking telopeptide of type I collagen and procollagen type I amino-terminal propeptide using two fully automated immunoassays
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