Title: Certified reference material against PR3 ANCA IgG autoantibodies. From development to certification
Citation: CLINICAL CHEMISTRY AND LABORATORY MEDICINE vol. 57 no. 8 p. 1197-1206
Publication Year: 2018
JRC N°: JRC113342
ISSN: 1434-6621 (online)
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC113342
DOI: 10.1515/cclm-2018-1095
Type: Articles in periodicals and books
Abstract: The importance of the standardisation of immunoassays for autoantibodies has been widely discussed. The appropriate use of Certified Reference Materials (CRMs) could contribute to a more accurate diagnosis and follow-up of a series of diseases such as small vessel-associated vasculitis. This is a systemic autoimmune disorder that leads to necrosis of blood vessel walls and during which two autoantibodies can be present, MPO ANCA IgG and PR3 ANCA IgG. Results from different commercially available immunoassays used for PR3 ANCA IgG measurement can vary significantly. Therefore the potential for improvement using a certified reference material was assessed and led to the development of a CRM. The evaluation of two sets of 30 clinical samples with 10 assays showed that differences between assays can result in different interpretations for individual clinical samples. Most of the samples had the same classification in all assays. However, six of the samples tested did not. The correlation between results from 10 different assays was assessed in a pairwise manner. The correlation between results from clinical samples was systematically good for combinations of 8 of those assays. Therefore it should be possible to improve the comparability of results using a commutable certified reference material for calibration. Feasibility studies were conducted in order to find a reference material format most suitable for the preparation of such a Certified Reference Material. Based on these studies, a final format for the CRM was selected and eventually produced and certified for its PR3 ANCA IgG content.
JRC Directorate:Health, Consumers and Reference Materials

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