[Standardization of specific laboratory methods within the framework of a therapeutic study of rheumatic diseases]

Immunological techniques and immunophenomena are acquiring an increasing significance in the diagnosis and control of rheumatic diseases. Alongside clinical, radiological, and biochemical investigations, they play an important role in the evaluation of a therapy and in the control of its benefits and side effects. It follows that immunological investigations and techniques should be taken into consideration when a multicenter trial is planned. However, this means that reproducible and thus comparable results must be obtained by the different laboratories participating in a multicenter therapeutic study. Exact standardization of the immunological test systems used is necessary, at least between the participants in the trial. Another critical point lies in the different clinical relevance and the distinct diagnostic value of the various immunophenomena and test systems. These differences must be strongly taken into account to minimize the effort and increase the effect of the investigations and the relevance of the results.