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Bayesian analysis of an international ELISA comparability study

  • Katy Klauenberg EMAIL logo , Bernd Ebert , Jan Voigt , Monika Walzel , James E. Noble , Alex E. Knight and Clemens Elster
Published/Copyright: July 5, 2011
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 49 Issue 9

Abstract

Background: Immunoassays are biochemical tests applied to measure even very small amounts of substance using the highly specific binding between an antibody and its antigen. They have a wide range of applications. The measurement however, might be associated with substantial uncertainty; this can have significant consequences for any diagnosis, or clinical decision. An international comparability study was thus performed to assess the sources of uncertainty involved in the estimation of a protein cytokine concentration using a fluorescent ELISA.

Methods: In contrast to the original publication for this international comparability study, we reanalyse the data using Bayesian inference. This provides a statistically coherent approach to estimate ELISA concentrations and their associated uncertainties.

Results: The Bayesian uncertainties of individual ELISAs and laboratory estimates are considerably larger than previously reported uncertainties. The average concentrations estimated here differ from the ones estimated by each study participant. In general, this leads to different conclusions about the study. In particular, the inter- and intra-laboratory consistency is increased, and repeatability problems occur for fewer laboratories.

Conclusions: Decisions which are based on plausible ranges of measurements (such as credible intervals), are generally superior to those solely based on point estimates (such as the mean). Reliable uncertainties are thus vital, and not only in metrology. In this paper, a general method is developed to derive concentration estimates and valid uncertainties for ELISAs. Guidance on applying this Bayesian method is provided and the importance of reliable uncertainties associated with ELISAs is underlined. The applicability and virtues of the presented method are demonstrated in the context of an international comparability study.

Keywords: Bayesian inference; CCQM; fluorescent ELISA; uncertainty
Corresponding author: Katy Klauenberg, Physikalisch-Technische Bundesanstalt (PTB), Abbestr. 2-12, 10587 Berlin, Germany Phone: +49 30 3481 7614, Fax: +49 30 3481 69 7614
Received: 2011-1-24
Accepted: 2011-4-12
Published Online: 2011-07-5
Published in Print: 2011-09-01

©2011 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/CCLM.2011.648
Keywords for this article
Bayesian inference; CCQM; fluorescent ELISA; uncertainty

Articles in the same Issue

  1. Editorial
  2. Athlete's biological passport: to test or not to test?
  3. Review
  4. Prognostic value of cystatin C in acute coronary syndromes: enhancer of atherosclerosis and promising therapeutic target
  5. Opinion Papers
  6. The function of oxalic acid in the human metabolism
  7. Current limitations of the Athlete's Biological Passport use in sports
  8. Limits and pitfalls of Athlete's Biological Passport
  9. The Athlete Biological Passport from the perspective of an anti-doping organization
  10. Perspectives
  11. Genetics of infectious diseases: hidden etiologies and common pathways
  12. Guidelines and Recommendations
  13. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 9: Reference procedure for the measurement of catalytic concentration of alkaline phosphatase
  14. Genetics and Molecular Diagnostics
  15. A template for mutational data analysis of the CFTR gene
  16. High resolution melting analysis to genotype the most common variants in the HFE gene
  17. General Clinical Chemistry and Laboratory Medicine
  18. Bayesian analysis of an international ELISA comparability study
  19. Inflammatory markers in preeclamptic patients
  20. Pre-analytical effects of different lithium heparin plasma separation tubes in the routine clinical chemistry laboratory
  21. Pre-acquisition system assessment of the Sysmex® Coagulation System CS-2100i and comparison with end-user verification; a model for the regional introduction of new analysers and methods
  22. Evaluation of a commercially available rapid urinary porphobilinogen test
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  28. Infectious Diseases
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  30. Prognostic value of serum angiotensin-converting enzyme activity for outcome of community-acquired pneumonia
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  33. N-terminal pro-B-type natriuretic peptide in early and advanced phases of obesity
  34. Vaspin plasma concentrations and mRNA expressions in patients with stable and unstable angina pectoris
  35. Prospective study of first stroke in relation to plasma homocysteine and MTHFR 677C>T and 1298A>C genotypes and haplotypes – evidence for an association with hemorrhagic stroke
  36. Letters to the Editor
  37. Evaluation of the analytical performance of the Beckman Coulter AU680 automated analytical system based on quality specifications for allowable performance derived from biological variation
  38. Collagen peptides, interstitial remodelling and sudden cardiac death in hypertrophic cardiomyopathy
  39. Erratum
  40. Modified phosphatidylserine-dependent antiprothrombin ELISA enables identification of patients negative for other antiphospholipid antibodies and also detects low avidity antibodies
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