Standardisation in clinical laboratory medicine: an ethical reflection
1 Laboratory Medicine, University Hospitals Leuven, Belgium
2 Governance and Ethics, Vlerick Leuven Gent Manangement School, Belgium
3 Department of Autoimmunity, Statens Serum Institute, Denmark
Correspondence to:
Xavier Bossuyt, Laboratory Medicine, Immunology, University Hospital Leuven, Herestraat 49, B-3000 Leuven, Belgium; xavier.bossuyt@uz.kuleuven.ac.be
Accepted 30 March 2008
| The first 150 words of the full text of this article appear below. |
Many efforts have been undertaken to standardise diagnostic tests. For example, the introduction of CRM-470, an international reference preparation for proteins in human serum1 has reduced the among-laboratory variance of protein quantification.2 (The examples provided are from the field of Clinical Laboratory Immunology and Protein Chemistry.) The Dutch Red Cross Institute together with the World Health Organization (WHO) prepared an international standard for quantification of antibodies to double-stranded DNA.3 The International Union of Immunological Societies (IUIS), together with the American Arthritis Foundation and the Centers of Disease Control (CDC), made available reference sera selected by the International Committee on Autoantibody Testing in Rheumatic Diseases and Related Disorders for detecting anti-nuclear antibodies.4 These initiatives improved worldwide harmonisation of laboratory test results.
However, despite efforts to harmonise laboratory tests, reference reagents are still lacking for many tests. For example, standardisation is unsatisfactory for IgG subclass determination.5
A number of promising new laboratory
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