Representation and performance of CE-marked and in-house <i>in vitro</i> diagnostic tests for routine laboratory parameters in external quality assessment programmes
IH-IVDs accounted for only a minimal proportion of tests. EQA results obtained with them showed no inferiority to those obtained with CE-IVDs. Furthermore, our findings show that EQA data are a useful tool for examining the analytical landscape, possibly even beyond the national level. Studies on the use and performance of IH-IVDs should be conducted based on EQA programmes for laboratory diagnostic areas where their proportion is likely to be higher.
Authors
- Christoph Buchta (ORCID: https://orcid.org/0000-0002-4153-8195)
- Andreas Bietenbeck (ORCID: https://orcid.org/0000-0002-1228-0770)
- Folker Spitzenberger (ORCID: https://orcid.org/0000-0001-9434-0599)
- M. Neumaier
- Christian Schweiger
- Karina Hellbert
- Alireza Karimi
- Andrea Griesmacher
Institutions
- Bechtel (United States) (US)
- Heidelberg University (DE)
- University Hospital Heidelberg (DE)
- Agency for Quality Assurance and Accreditation Austria (AT)
- Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer (DE)
- Technical University of Applied Sciences Lübeck (DE)
- University Medical Centre Mannheim (DE)
- University Hospital Innsbruck (AT)
- Medical University of Vienna (AT)
Publication Details
- Journal
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Published
- 2026-03-17
- DOI
- https://doi.org/10.1515/cclm-2026-0288
- Primary Topic
- Quality and Safety in Healthcare
- Type
- article
- Field-Weighted Citation Impact
- 0.00