Studies in the Determination of Reference Values for In-Vitro Diagnostic Devices

摘要

This report contains an analysis of the contents of the open literature concerning reference values (or normal values) through July 30, 1979. The scope of the literature search is indicated in Appendix A. From over 1,000 citations in the literature, abstracts were reviewed and over 150 papers retrieved for use in the report. 'Reference value' is a term that has been defined only during the last decade and many worthwhile notions were introduced before the term came into use; and, therefore, many of the papers used in this report discuss 'normal values'. The relationship between these terms is examined by this report. The most active groups from the results of this survey appear to be the International Federation of Clinical Chemistry and the Scandinavian Society of Clinical Chemistry. Reports from both of these groups are reviewed.