CLSI C49-A

This document provides guidance for the application of widely available measurement procedures for testing body fluids and for reporting and interpreting those results. It emphasizes defining the common clinical situations for this use; acceptable practice for measuring analytes without extended method verification for abnormal body fluid; influence of biologic and analytic variation on interpretation of results; and 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.