scope:

Foreword

The current literature contains may examples of user and manufacturer product evaluations, with many different experimental and statistical procedures for comparing two methods that measure the same analyte. This methodologic variety has caused confusion, and users have reported that comparisons often lack sufficient data and description to be reproducible.

There has also been an increasing awareness that the scope of evaluation procedures appropriate for manufacturers of diagnostic devices is not always appropriate for their users. The manufacturer is concerned with establishing valid and achievable performance claims for bias when compared with a generally accepted standard or reference method. The user might wish to compare a candidate method with a different one than the manufacturer used in establishing the bias claims. The scope of the experimental and data-handling procedures for these two purposes can often differ.