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Six years of INSTAND e. V. sIgE proficiency testing: an evaluation of in vitro allergy diagnostics

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Abstract

Background

Even though allergies are an important health issue, wide manufacturer-dependent differences in the detected amounts of allergen-specific IgE (sIgE) have repeatedly been found. These discrepancies hinder diagnostics and research into clinically significant cutoff points for life-threatening symptoms.

Methods

To evaluate whether the reported differences have led to changes in diagnostic testing, we analyzed data from six years of round robin testing (RRT, also known as proficiency testing) at the Institute of Standardization and Quality Control in Medical Laboratories (INSTAND e. V.) for the important allergen sources bee venom, wasp venom, and birch pollen. The results of the four main suppliers of in vitro diagnostic sIgE testing were compared in a pseudo-anonymized form using overlay images of box plot graphs for the semiquantitative data and allergen class results. Coefficients of variation (CV) were obtained to study the development of interlaboratory comparability.

Results

We found that the large differences between the manufacturer collectives remained constant between January 2010 and April 2015 without any real improvement. The CVs were good for two of the four analyzed suppliers, one was marginal and one above the quality level of 20 %.

Conclusion

The numerous publications that have found discrepancies in the sIgE results of the different suppliers did not change the status quo within the last six years. Unfortunately, this is unlikely to change until there is a characterized standard material with known values of sIgE.

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Abbreviations

CCD:

Cross-reactive carbohydrate structure

CV:

Coefficient of variation

INSTAND:

Institute of Standardization and Quality Control in Medical Laboratories

RfB:

Reference Institute for Bioanalytics

RRT:

Round robin test

sIgE:

Specific IgE

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Authors and Affiliations

  1. Hochschule Anhalt, Bernburg, Germany

    Nathalie Wojtalewicz, Kathrin Kabrodt &  Ingo Schellenberg

  2. INSTAND e.V., Düsseldorf, Düsseldorf, Germany

    Sabine Goseberg

  3. Center of Life Sciences, AG IBAS, Hochschule Anhalt, Stenzfelder Allee 28, 06406, Bernburg (Saale), Germany

    Ingo Schellenberg

Authors
  1. Nathalie Wojtalewicz
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  2. Sabine Goseberg
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  3. Kathrin Kabrodt
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  4. Ingo Schellenberg
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Corresponding author

Correspondence to Ingo Schellenberg.

Additional information

Authors’ contributions

Wojtalewicz N. performed the statistical analysis, generated the figures, and wrote the paper. Goseberg S. collected and pooled the INSTAND e. V. data. Kabrodt K. corrected the paper and Schellenberg I. is the corresponding author as well as the EQA expert for in vitro allergy round robin tests. He is also vice president of INSTAND e. V.

Acknowledgements

We would like to thank King for proofreading the manuscript.

Conflict of interest

The authors declare that there are no conflicts of interest.

Cite this as

Wojtalewicz N, Goseberg S, Kabrodt K, Schellenberg I. Six years of INSTAND e. V. sIgE proficiency testing: an evaluation of in vitro allergy diagnostics. Allergo J Int 2017; 26: 43–52

DOI: 10.1007/s40629-016-0005-8

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Wojtalewicz, N., Goseberg, S., Kabrodt, K. et al. Six years of INSTAND e. V. sIgE proficiency testing: an evaluation of in vitro allergy diagnostics. Allergo J 26, 20–29 (2017). https://doi.org/10.1007/s15007-017-1297-9

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  • DOI: https://doi.org/10.1007/s15007-017-1297-9

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