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Introduction and Scope

This document provides both users and manufacturers of clinical laboratory devices with guidance for designing an experiment to evaluate the bias between two methods that measure the same analyte. Ideally, a test (or candidate) method should be compared with a reference method. For users, the comparative method is often the current routine method, however, and the purpose of the evaluation is to determine if the two methods yield equivalent results within the statistical power of the experiment. In this case, determining whether the test method is a suitable replacement for a current method is the primary concern.

This guideline allows the estimation of the bias (expected difference) between two methods at various concentrations. If the comparative method is the same one used by the manufacturer in the statement of claims, it is possible to compare statistically the experimental results to the manufacturer's claims to verify acceptable performance.