scope:

C49 provides guidance to medical laboratories for the appropriate application of measurement procedures for body fluid testing and for reporting results. This guideline primarily focuses on the recommended practice for verification of measurement procedures for measurands in body fluids and is applicable for laboratory testing requests on body fluids that do not have performance claims in the manufacturer's package insert or an equivalent validated laboratory-developed test. C49 does not cover serum, plasma, whole blood, urine, or fluids (eg, cerebrospinal fluid) for which measurement procedures typically have performance claims in the manufacturer's package insert.