scope:

CLSI document C49 provides guidance to the clinical laboratory director for the application of measurement procedures for testing body fluids, and for reporting and interpreting those results. The document emphasizes: the most common clinical situations; acceptable practice for measuring analytes without extended method verification for abnormal body fluids; the influence of biologic and analytic variation on interpretation of results; and the variability in comparing results between different instrument manufacturers.

This document does not consider serum, plasma, whole blood, or fluids for which assays typically have performance claims in the measurement procedure documentation.