ABSTRACT

In a few years there will be a United Europe, and the European Community will gradually replace the old national regulations. Many problems should be solved before 1992, the year in which European harmonization should be a fact. This European harmonization includes agreement about qualities of products— not only in foods and drugs, but also in drug assays. The cost of an assay will become the European market price, which often will be in conflict with the quality of the results. Consequently, there should be a European control of laboratory performance. Perhaps there will be a European certification for laboratories to ensure the quality of their performance. In January 1990, some 300 laboratories in and outside Europe were invited to take part in this study. Approximately 200 of them answered positively, and to those laboratories serum specimens were sent.