Allergy: Evaluation of 16 years (2007–2022) results of the shared external quality assessment program in Belgium, Finland, Portugal and The Netherlands

Author:

Heron Michiel1ORCID,Schreurs Marco W.J.2,Haagen Inez-Anne3,China Bernard4,Faria Ana Paula5,Vanhanen Anna-Riitta6,Thelen Marc78ORCID,Weykamp Cas W.9

Affiliation:

1. Medical Microbiology and Immunology, Diakonessenhuis , Utrecht , The Netherlands

2. Microvida Laboratory of Medical Microbiology and Immunology , Elisabeth-TweeSteden Ziekenhuis , Tilburg , The Netherlands

3. Department of Hematology and Clinical Chemistry Laboratory , OLVG Lab , Amsterdam , The Netherlands

4. Department of Quality of Laboratories , Sciensano , Brussel , Belgium

5. Department of Epidemiology , External Quality Assessment Unit Nacional Institute of Health, Doctor Ricardo Jorge , Lisbon , Portugal

6. Labquality , Helsinki , Finland

7. Department of Laboratory Medicine , Radboud University Medical Centre , Nijmegen , The Netherlands

8. Foundation for Quality Assurance in Laboratory Medicine (SKML) , Nijmegen , The Netherlands

9. Department of Clinical Chemistry , Queen Beatrix Hospital , Winterswijk , The Netherlands

Abstract

Abstract Objectives This paper evaluates 16 year results of the Allergy EQA program shared by EQA organisers in Belgium, Finland, Portugal, and The Netherlands. Methods The performance of Thermo Fisher and Siemens user groups (in terms of concordance between both groups, between laboratory CV, prevalence of clinically significant errors) and suitability of samples (stability and validity of dilution of patient samples) are evaluated using data of 192 samples in the EQA programs from 2007 to 2022. Measurands covered are total IgE, screens and mixes, specific IgE extracts and allergen components. Results There is perfect (53 %), acceptable (40 %) and poor (6 %) concordance between both method groups. In case of poor concordance the best fit with clinical data is seen for Thermo Fisher (56 %) and Siemens (26 %) respectively. The between laboratory CV evolves from 7.8 to 6.6 % (Thermo Fisher) and 7.3 to 7.7 % (Siemens). The prevalence of blunders by individual laboratories is stable for Siemens (0.4 %) and drops from 0.4 to 0.2 % for Thermo Fisher users. For IgE, the between year CV of the mean of both user groups is 1 %, and a fifteen-fold dilution of a patient sample has an impact of 2 and 4 % on the recovery of Thermo Fisher and Siemens user groups. Conclusions The analytical performance of Thermo Fisher is slightly better than that of Siemens users but the clinical impact of this difference is limited. Stability of the sample and the low impact of dilution on the recovery of measurands demonstrates the suitability for purpose of the EQA program.

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

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