First steps in the standardization of immunoglobulin IgG myeloperoxidase-anti-neutrophil cytoplasmic antibody measurements

The standardisation of immunoassays for IgG anti-MPO ANCA could contribute to a more accurate diagnosis and follow-up of small vessels-associated vasculitis, a systemic autoimmune disorder that leads to necrosis of blood vessel walls. Despite significant efforts by different groups, the level of comparability of results from commercially available immunoassays used for IgG anti-MPO detection is still poor. Therefore the potential for improvement using reference materials was assessed. The evaluation of a set of 30 patient samples with 11 assays showed that differences between assays result in different interpretations for individual patients. Only 10 out of 30 patient samples had the same clinical interpretation among 11 assays applying the cut-off values provided by each respective manufacturer. The correlation between results from 13 different assays was assessed in a pairwise manner. The correlation between results from patient samples was systematically very good for combinations of 7 of those assays The correlation of results ranged from reasonable to good for combinations with 4 other assays. Therefore it should be possible to improve the comparability of results using a commutable reference material for calibration. Feasibility studies were conducted in order to find a reference material format most suitable for a calibrator. Two sets of candidate reference materials were produced from different raw materials, and assessed according to their suitability. A final format was selected, and a candidate reference material was produced.

HUTU Dana Petronela;  TUDDENHAM Emma;  MONOGIOUDI Evanthia;  MERONI Pierluigi;  SCHIMMEL Heinz;  SHELDON Joanna;  ZEGERS Ingrid; 

2016-01-21

WILEY-BLACKWELL

JRC97260

0009-9104,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC97260,   

10.1111/cei.12707,