The IV Immunochemistry Workshop supported by the 鈥淪ociedad Espa帽ola de Inmunolog铆a鈥?(SEI), consisted in a series of interlaboratory comparative studies to evaluate the homogeneity of the analytic methods in immunochemistry. The objective was to develop quality control tools to standardise diagnostic analytic procedures.
21 centres have participated in the Workshop. It comprised the quantification of IgG, IgA, IgM, and total IgE 魏 and 位 light chain Immunoglobulin; Complement C3 and C4; Rheumatoid Factor (RF); C-reactive protein (CRP), and Antiestreptolysin O (ASL) in commercial control serum samples. Monoclonal immunoglobulins present in serum and urine samples were also characterized. For the first time, the study of LCR oligoclonal bands in the serum and cerebrospinal fluid was incorporated. The study was performed using the routine methods currently used in each laboratory. The participant laboratories sent the records of the results to the workshop coordinators that proceeded to analyse them. Conclusions were presented at the XXXI Congress of the SEI.
Analytical parameters standardised by the International Federation of Clinical Chemistry (IFCC) showed a good homogeneity. Analytical parameters not standardised by IFCC showed higher heterogeneity. The identification of the monoclonal proteins in serum and urine was highly homogeneous. The quantitative results of monoclonal isotypes were more heterogeneous than those of polyclonal immunoglobulins. The results on oligoclonal bands reported in serum and cerebrospinal fluid were homogeneous.
Comparative studies are very useful to investigate the homogeneity among different laboratories. These results demonstrate the utility of standarization procedures developed by International Organizations, but also the need of quality controls, the evaluation of suppliers, and the elaboration of consensus working procedures.