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Quality and best practice in medical laboratories: specific requests for autoimmunity testing
Ulrich Sack1, Xavier Bossuyt2, Hristina Andreeva3
1Medical Faculty, Institute of Clinical Immunology, University Leipzig, Leipzig, Germany. ulrich.sack@medizin.uni-leipzig.de.
Auto- Immunity Highlights
|September 5, 2020
Summary
Laboratory autoimmune testing faces challenges with current regulations and guidelines. This review by the European Autoimmunity Standardisation Initiative (EASI) aims to create a quality control framework for EN/ISO accreditation.
Area of Science:
- Clinical Immunology
- Laboratory Medicine
- Regulatory Science
Background:
- Autoimmune testing faces challenges adapting to new regulatory frameworks like EN/ISO 15189 and IVD-R.
- International guidelines for autoantibody testing lack specific requirements, creating ambiguity for laboratories.
Purpose of the Study:
- To identify quality issues in autoantibody testing and establish a consensus-based framework for EN/ISO accreditation.
- To unify national guidelines and provide a European handout on quality control for autoimmune testing laboratories.
Main Methods:
- A review of current publications and guidelines was conducted.
- Laboratory specialists from multiple European countries shared national experiences and identified quality issues.
- A consensus was sought on critical items for accreditation.
Main Results:
- Identified critical quality issues in autoantibody testing across various European countries.
- Found a strong, widespread commitment to quality assurance despite local variations.
Conclusions:
- A unified framework for quality control and accreditation in autoantibody testing is needed.
- The findings provide a basis for harmonizing national guidelines and improving laboratory accreditation processes.
